1,830 results match your criteria Contemporary clinical trials[Journal]


YMCA exercise intervention to augment smoking cessation treatment in adults with high anxiety sensitivity: Study protocol for a randomized controlled trial.

Contemp Clin Trials 2018 Dec 14. Epub 2018 Dec 14.

Department of Psychology, Institute for Mental Health Research, University of Texas at Austin, Austin, TX, United States.

Extant evidence suggests that exercise can reduce anxiety related vulnerability factors, such as anxiety sensitivity (AS), or fear of bodily sensations related to anxiety, that negatively impact smoking cessation outcomes. Building upon emerging evidence supporting the efficacy of exercise as an aid for smoking cessation in adults with high AS, we are conducting a trial to examine the efficacy and feasibility of this clinical application when implemented in a community setting. Partnering with the YMCA, this study aims to enroll 150 adults in a standard smoking cessation protocol (i. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.001DOI Listing
December 2018

Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors.

Contemp Clin Trials 2018 Dec 12. Epub 2018 Dec 12.

Moores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, 9300 Campus Pointe Drive, MC 7433, La Jolla, CA 92037, USA. Electronic address:

Background: Young breast cancer survivors (YBCS) have unmet needs for managing hot flashes, fertility-related concerns, sexual health and contraception.

Purpose: Describe the design and participant characteristics of a randomized controlled trial testing the efficacy of the survivorship care plan on reproductive health (SCP-R) intervention on improving hot flashes, fertility-related concerns, sexual health, and contraception in YBCS.

Methods: SCP-R is a web-based intervention with text message support encompassing evidence- based practices on four reproductive health issues. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.002DOI Listing
December 2018

Telephone-delivered cognitive behavioral therapy for veterans with chronic pain following traumatic brain injury: Rationale and study protocol for a randomized controlled trial study.

Contemp Clin Trials 2018 Dec 13;76:112-119. Epub 2018 Dec 13.

Department of Rehabilitation Medicine, Box 356490, University of Washington, Seattle, Washington 98195-6490, USA; VA Puget Sound Healthcare System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, USA. Electronic address:

Background And Objectives: Chronic pain is a highly prevalent and potentially disabling condition in Veterans who have had a traumatic brain injury (TBI) and access to non-pharmacological pain treatments such as cognitive behavioral therapy is limited and variable. The purpose of this randomized controlled trial (RCT) is to evaluate the efficacy of a telephone-delivered cognitive behavioral therapy (T-CBT) for pain in Veterans with a history of TBI.

Methods: Veterans with a history of TBI and chronic pain of at least six months duration (N = 160) will be randomized to either T-CBT or a telephone-delivered pain psychoeducational active control condition (T-Ed). Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183044
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http://dx.doi.org/10.1016/j.cct.2018.12.004DOI Listing
December 2018
2 Reads

Design and methodology of a cluster-randomized trial in early care and education centers to meet physical activity guidelines: Sustainability via Active Garden Education (SAGE).

Contemp Clin Trials 2018 Dec 11. Epub 2018 Dec 11.

Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.

Strategies are needed to help early care and education centers (ECEC) comply with policies to meet daily physical activity and fruit and vegetable guidelines for young children. This manuscript describes the design and methodology of Sustainability via Active Garden Education (SAGE), a 12-session cluster-randomized controlled crossover design trial using community-based participatory research (CBPR) to test a garden-based ECEC physical activity and fruit and vegetables promotion intervention for young children aged 3-5 years in 20 sites. The SAGE curriculum uses the plant lifecycle as a metaphor for human development. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183033
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http://dx.doi.org/10.1016/j.cct.2018.12.003DOI Listing
December 2018
2 Reads

Remission from chronic opioid use-Studying environmental and socio-economic factors on recovery (RECOVER): Study design and participant characteristics.

Contemp Clin Trials 2018 Nov 30;76:93-103. Epub 2018 Nov 30.

Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States. Electronic address:

Few opioid use disorder (OUD) treatment studies measure meaningful life changes during long-term recovery, focusing instead on retention and abstinence. Here, we report on the design and participant characteristics of the RECOVER study, a study exploring life changes in persons with OUD for up to 24 months following participation in a Phase III trial evaluating buprenorphine extended-release monthly injection for subcutaneous use (known as RBP-6000 during development). This multisite, observational, cohort study tracks clinical, environmental, and socio-economic changes using self-administered assessments, urine drug screens (UDS), and public databases. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183057
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http://dx.doi.org/10.1016/j.cct.2018.11.015DOI Listing
November 2018
2 Reads

Diabetes sleep treatment trial: Premise, design, and methodology.

Contemp Clin Trials 2018 Dec 2;76:104-111. Epub 2018 Dec 2.

University of Pittsburgh School of Nursing, 3500 Victoria Street, Pittsburgh, PA, United States.

The Diabetes Sleep Treatment Trial (DSTT) is a multi-site, double-blinded, randomized, sham-controlled trial. The study objective is to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) treatment results in improved glycemic control and diabetes self-management behavior compared to participants on a sham-CPAP (sub-therapeutic) device in participants with type 2 diabetes mellitus (T2DM) and co-morbid OSA. The purpose of this paper is to describe the premise for the DSTT, the study design, and the methodology used in this on-going trial. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.014DOI Listing
December 2018
2 Reads

The weWomen and ourCircle randomized controlled trial protocol: A web-based intervention for immigrant, refugee and indigenous women with intimate partner violence experiences.

Contemp Clin Trials 2018 Dec 2;76:79-84. Epub 2018 Dec 2.

Johns Hopkins University School of Nursing, 525 N Wolfe Street, Baltimore MD-21205, USA. Electronic address:

Intimate partner violence (IPV), including homicides is a widespread and significant public health problem, disproportionately affecting immigrant, refugee and indigenous women in the United States (US). This paper describes the protocol of a randomized control trial testing the utility of administering culturally tailored versions of the danger assessment (DA, measure to assess risk of homicide, near lethality and potentially lethal injury by an intimate partner) along with culturally adapted versions of the safety planning (myPlan) intervention: a) weWomen (designed for immigrant and refugee women) and b) ourCircle (designed for indigenous women). Safety planning is tailored to women's priorities, culture and levels of danger. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.013DOI Listing
December 2018

Shake Rattle & Roll - Design and rationale for a pragmatic trial to improve blood pressure control among blacks with persistent hypertension.

Contemp Clin Trials 2018 Nov 28;76:85-92. Epub 2018 Nov 28.

Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.

Background: In Kaiser Permanente Northern California (KPNC), members had similar access to care and a very high overall rate of hypertension control. However, blacks had poorer blood pressure (BP) control than whites. The Shake Rattle & Roll (SRR) trial aimed to improve BP control rates in blacks and to reduce disparities in hypertension control. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.012DOI Listing
November 2018
1 Read

Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET).

Contemp Clin Trials 2018 Nov 22. Epub 2018 Nov 22.

Division of Medical Oncology, Duke University, Durham, NC, United States. Electronic address:

Adjuvant endocrine therapy (AET) is used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem and contributes to increased medical costs and mortality. A variety of problematic symptoms associated with AET are related to non-adherence and early discontinuation of treatment. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.010DOI Listing
November 2018
5 Reads

Pediatric continuity care intensivist: A randomized controlled trial.

Contemp Clin Trials 2018 Nov 20;76:72-78. Epub 2018 Nov 20.

Children's Hospital of Philadelphia, Philadelphia, PA, United States.

Introduction: Long-stay critically ill patients in the Pediatric Intensive Care Unit (PICU) may be at risk for inconsistencies in treatment plan, delay in plan progression, and patient/family dissatisfaction with communication. This article describes the development and evaluation of an intervention designed to improve continuity and communication delivered by continuity PICU attendings.

Methods And Analysis: A randomized controlled trial of an intervention in one PICU that was randomized at the patient level. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.011DOI Listing
November 2018
3 Reads

The Healthy Weigh study of lottery-based incentives and environmental strategies for weight loss: Design and baseline characteristics.

Contemp Clin Trials 2018 Oct 26;76:24-30. Epub 2018 Oct 26.

University of Pennsylvania Center for Health Incentives and Behavioral Economics, 423 Guardian Drive, 11th Floor Blockley Hall, Philadelphia, PA 19104, United States. Electronic address:

Identifying effective strategies for treating obesity is a clinical challenge and a public health priority. The present study is an innovative test of the relative effectiveness of lottery-based financial incentives and environmental strategies on weight loss and maintenance. The Healthy Weigh study is evaluating the comparative effectiveness of behavioral economic financial incentives and environmental strategies, separately and together, in achieving initial weight loss and maintenance of weight loss, in obese urban employee populations. Read More

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http://dx.doi.org/10.1016/j.cct.2018.10.013DOI Listing
October 2018
2 Reads

Rationale and design for eHealth Familias Unidas Primary Care: A drug use, sexual risk behavior, and STI preventive intervention for hispanic youth in pediatric primary care clinics.

Contemp Clin Trials 2018 Nov 17;76:64-71. Epub 2018 Nov 17.

Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Prevention Implementation Methodology (Ce-PIM), Northwestern University, Chicago, IL, USA.

Family-based behavioral interventions are efficacious and effective in preventing drug use and sexual risk behaviors; unfortunately, they have not been evaluated and disseminated in pediatric primary care practice, where they can have a significant impact. There is an increased focus on integrating parenting interventions into primary care to reduce health disparities among ethnic minorities such as Hispanics. Although Hispanic youth demonstrate higher levels of drug use and sexual risk behaviors than their non-Hispanic counterparts, few parenting interventions are available for Hispanic youth, and none have been delivered specifically to Hispanic adolescents in primary care. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183037
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http://dx.doi.org/10.1016/j.cct.2018.11.005DOI Listing
November 2018
6 Reads

Fit & quit: An efficacy trial of two behavioral post-cessation weight gain interventions.

Contemp Clin Trials 2018 Nov 13;76:31-40. Epub 2018 Nov 13.

Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N. Pauline St., Memphis, TN 38163, USA.

While smoking cessation leads to significant improvements in both mortality and morbidity, post-cessation weight gain partially attenuates this benefit. Even though post-cessation weight gain is small (4.7 kg on average), it is a stated reason to delay cessation attempts and is associated with smoking relapse. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.009DOI Listing
November 2018

Rationale and design of the Hepatocellular carcinoma Early Detection Strategy study: A multi-center longitudinal initiative of the National Cancer Institute's Early Detection Research Network.

Contemp Clin Trials 2018 Nov 12;76:49-54. Epub 2018 Nov 12.

Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd 7S, Philadelphia, PA, 19104, USA. Electronic address:

Background: Hepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is presently the leading risk factor for developing HCC. Abdominal imaging, with or without alpha-fetoprotein (AFP) testing, every 6 months is the current surveillance strategy for patients at risk. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.008DOI Listing
November 2018
2 Reads
1.990 Impact Factor

Attentional bias modification treatment for depression: Study protocol for a randomized controlled trial.

Contemp Clin Trials 2018 Dec 26;75:59-66. Epub 2018 Oct 26.

University of Texas at Austin, USA.

Theoretical models and empirical research point to negatively biased attention as a maintaining factor in depression. Although preliminary studies suggest experimentally modifying attentional biases (i.e. Read More

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http://dx.doi.org/10.1016/j.cct.2018.10.014DOI Listing
December 2018
1 Read

Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials.

Contemp Clin Trials 2018 Nov 8;76:1-8. Epub 2018 Nov 8.

Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Introduction: The most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by encouraging enrollment preferentially among the poor. Neither of these concerns has been shown to manifest in studies testing the effects of incentives on decisions to participate in hypothetical randomized clinical trials (RCTs), but neither has been assessed in real RCTs.

Methods And Analyses: We are conducting randomized trials of real incentives embedded within two parent RCTs. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183051
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http://dx.doi.org/10.1016/j.cct.2018.11.007DOI Listing
November 2018
9 Reads

Design of ChooseWell 365: Randomized controlled trial of an automated, personalized worksite intervention to promote healthy food choices and prevent weight gain.

Contemp Clin Trials 2018 Dec 7;75:78-86. Epub 2018 Nov 7.

Harvard Medical School, Boston, MA, United States; Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, United States. Electronic address:

Background/aims: Behavioral nudges in the food environment increase healthy choices, but it is unknown if they improve diet and health. The ChooseWell 365 study will determine if an automated, personalized worksite intervention to nudge healthier choices improves overall diet and cardiometabolic health.

Design: Randomized controlled trial of 602 hospital employees who regularly use on-site cafeterias and pay with an employee ID. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183041
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http://dx.doi.org/10.1016/j.cct.2018.11.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6258180PMC
December 2018
5 Reads

Design of the Rural LEAP randomized trial: An evaluation of extended-care programs for weight management delivered via group or individual telephone counseling.

Contemp Clin Trials 2018 Nov 6;76:55-63. Epub 2018 Nov 6.

University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA.

Obesity is a major contributor to the greater prevalence of chronic disease morbidity and mortality observed in rural versus nonrural areas of the U.S. Nonetheless, little research attention has been given to modifying this important driver of rural/urban disparities in health outcomes. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183043
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http://dx.doi.org/10.1016/j.cct.2018.11.006DOI Listing
November 2018
6 Reads

European paediatric non-alcoholic fatty liver disease registry (EU-PNAFLD): Design and rationale.

Contemp Clin Trials 2018 Dec 5;75:67-71. Epub 2018 Nov 5.

Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle Upon Tyne, United Kingdom; Liver Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, United Kingdom.

Non-alcoholic fatty liver disease (NAFLD) is the most common liver disorder in children and has the potential to progress to advanced fibrosis/cirrhosis, end-stage liver disease and hepatocellular carcinoma. However, the natural history of the condition is poorly understood and there are no approved treatments. The European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD) is a multi-centre registry of paediatric NAFLD that will serve as a prospective, observational, natural history study and provide a tractable back-bone to support recruitment into subsequent interventional trials. Read More

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https://www.journals.elsevier.com/contemporary-clinical-tria
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https://linkinghub.elsevier.com/retrieve/pii/S15517144183042
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http://dx.doi.org/10.1016/j.cct.2018.11.003DOI Listing
December 2018
5 Reads

Methods to improve the noninvasive diagnosis and assessment of disease severity in children with suspected nonalcoholic fatty liver disease (NAFLD): Study design.

Contemp Clin Trials 2018 Dec 27;75:51-58. Epub 2018 Oct 27.

Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.

Background: Nonalcoholic fatty liver disease (NAFLD) is strongly associated with obesity and is the most common liver disease in the developed world. In children with suspected NAFLD, present guidelines suggest consideration of alternative diagnoses via extensive blood testing, though the yield of this work up is unknown. Furthermore, the gold standard diagnostic test for NAFLD remains liver biopsy, making the development of non-invasive tests critically important. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183039
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http://dx.doi.org/10.1016/j.cct.2018.10.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249118PMC
December 2018
3 Reads

Improving quality of life among latino cancer survivors: Design of a randomized trial of patient navigation.

Contemp Clin Trials 2018 Nov 3;76:41-48. Epub 2018 Nov 3.

Department of Medicine, Division of Population Health and Computational Medicine, University of Miami at the Miller School of Medicine, Miami, FL, USA.

Latino cancer survivors have lower survival rates for most cancers relative to non-Latino whites, including, colorectal, prostate, and breast. In addition, Latinos experience health disparities in both access to care and quality of care. Experts recommend providing psychosocial services as an integral part of quality cancer care; however, there continues to be a paucity of information on the efficacy of Patient Navigators (PNs) in linking Latino cancer survivors to appropriate psychosocial services. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183052
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http://dx.doi.org/10.1016/j.cct.2018.11.002DOI Listing
November 2018
7 Reads

Enrollment and assessment of a first-year college class social network for a controlled trial of the indirect effect of a brief motivational intervention.

Contemp Clin Trials 2018 Nov 1;76:16-23. Epub 2018 Nov 1.

Oregon Research Institute, Eugene, OR, 97403, United States.

Heavy drinking and its consequences among college students represent a serious public health problem, and peer social networks are a robust predictor of drinking-related risk behaviors. In a recent trial, we administered a Brief Motivational Intervention (BMI) to a small number of first-year college students to assess the indirect effects of the intervention on peers not receiving the intervention.

Objectives: To present the research design, describe the methods used to successfully enroll a high proportion of a first-year college class network, and document participant characteristics. Read More

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http://dx.doi.org/10.1016/j.cct.2018.10.015DOI Listing
November 2018

The Integrating Pharmacogenetics in Clinical Care (I-PICC) Study: Protocol for a point-of-care randomized controlled trial of statin pharmacogenetics in primary care.

Contemp Clin Trials 2018 Dec 24;75:40-50. Epub 2018 Oct 24.

VA Boston Healthcare System, Boston, MA, USA.

Background: The association between the SLCO1B1 rs4149056 variant and statin-associated muscle symptoms (SAMS) is well validated, but the clinical utility of its implementation in patient care is unknown.

Design: The Integrating Pharmacogenetics in Clinical Care (I-PICC) Study is a pseudo-cluster randomized controlled trial of SLCO1B1 genotyping among statin-naïve primary care and women's health patients across the Veteran Affairs Boston Healthcare System. Eligible patients of enrolled primary care providers are aged 40-75 and have elevated risk of cardiovascular disease by American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183036
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http://dx.doi.org/10.1016/j.cct.2018.10.010DOI Listing
December 2018
8 Reads

Applications of general multistage gatekeeping and graphical multiple testing strategies in a clinical trial setting.

Contemp Clin Trials 2018 Oct 19;76:9-15. Epub 2018 Oct 19.

Data and Statistical Sciences, AbbVie Inc., 1 North Waukegan Road, North Chicago, IL 60064, USA.

Multiplicity adjustment plays a critical role for testing multiple endpoints and/or multiple doses in clinical trials. Under the clinical trial setting, multiple hypotheses are usually grouped into primary and secondary families and hierarchically ordered between and within families. The determination of the order and grouping of the hypotheses depends on the objectives of the trial. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144173081
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http://dx.doi.org/10.1016/j.cct.2018.10.004DOI Listing
October 2018
4 Reads

"Wellness Champions for Change," a multi-level intervention to improve school-level implementation of local wellness policies: Study protocol for a cluster randomized trial.

Contemp Clin Trials 2018 Dec 18;75:29-39. Epub 2018 Oct 18.

University of Maryland School of Medicine, Department of Pediatrics, Growth and Nutrition Division, 737 West Lombard Street, Baltimore, MD 21201, USA; University of Maryland School of Medicine, Department of Epidemiology and Public Health, 737 West Lombard Street, Baltimore, MD 21201, USA. Electronic address:

Schools are a recommended place for childhood obesity prevention. Local Wellness Policies (LWPs) establish guidelines for schools to provide opportunities for students to access nutritious foods and be physically active. Little is known about the impact of LWPs, when implemented, on students' behavior and body mass index (BMI). Read More

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http://dx.doi.org/10.1016/j.cct.2018.10.008DOI Listing
December 2018
1 Read

Design of a randomized controlled trial to decrease depression and improve insulin sensitivity in adolescents: Mood and INsulin sensitivity to prevent Diabetes (MIND).

Contemp Clin Trials 2018 Dec 17;75:19-28. Epub 2018 Oct 17.

Department of Pediatrics, Section of Endocrinology, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, United States.

Background: Depressive symptoms often manifest in adolescence and predict worsening insulin sensitivity, a key precursor in the path to β-cell failure and type 2 diabetes (T2D).

Objective: To assess the efficacy of a six-week cognitive-behavioral group versus six-week health education group for improving insulin sensitivity and preserving β-cell function in adolescent girls at-risk for T2D with depressive symptoms and evaluate mechanisms underlying the association between depression and insulin dynamics.

Design: Randomized controlled trial of N = 150 12-17-year-old girls with overweight/obesity (body mass index [BMI; kg/m2] ≥85th percentile), elevated depressive symptoms (Center for Epidemiologic Studies-Depression Scale [CES-D] total score > 20), and diabetes family history. Read More

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http://dx.doi.org/10.1016/j.cct.2018.10.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249074PMC
December 2018

School-based secondary prevention of overweight and obesity among 8- to 12-year old children: Design and sample characteristics of the SNAPSHOT trial.

Contemp Clin Trials 2018 Dec 18;75:9-18. Epub 2018 Oct 18.

Temple University, College of Public Health, Department of Nursing, 3307 North Broad Street, Philadelphia, PA 19103, United States.

Rising levels of severe obesity among children, worsening disparities by race and ethnicity and reluctance of primary care clinicians' to provide obesity management to children are compelling reasons to consider alternatives to primary care management of childhood obesity. The Students Nurses and Parents Seeking Healthy Options Together (SNAPSHOT) trial will test the efficacy of an elementary school-based, school nurse-led, healthy weight management program to reduce excess weight gain among children, 8- to 12-years old with a body mass index (BMI) ≥75th percentile, by increasing healthy dietary practices and physical activity and decreasing sedentary behaviors. SNAPSHOT has enrolled and randomized 132 child/parent dyads to either the: (1) 9-month SNAPSHOT intervention that includes four home visits, 14 kid groups held during out-of-school time and five parent groups or (2) a newsletter program consisting of monthly mailings and family-focused healthy lifestyle information. Read More

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http://dx.doi.org/10.1016/j.cct.2018.10.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249099PMC
December 2018

Results of a feasibility study of a patient informed, racially tailored home-based exercise program for black persons with multiple sclerosis.

Contemp Clin Trials 2018 Dec 18;75:1-8. Epub 2018 Oct 18.

Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.

Background: Exercise training is a promising approach for managing multiple sclerosis (MS), but existing research has not focused on black individuals with MS. This is important as black individuals with MS may experience a more aggressive disease course, increased comorbidities, and have a poorer prognosis with disease modifying therapies.

Materials And Methods: Thirty-two black adults with mild-to-moderate MS related disability participated in a patient-informed, three-month, home-based, racially tailored, exercise program. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183038
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http://dx.doi.org/10.1016/j.cct.2018.10.009DOI Listing
December 2018
4 Reads

iCanCope with Sickle Cell Pain: Design of a randomized controlled trial of a smartphone and web-based pain self-management program for youth with sickle cell disease.

Contemp Clin Trials 2018 Nov 11;74:88-96. Epub 2018 Oct 11.

The Hospital for Sick Children, Child Health Evaluative Sciences, Canada; Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada.

Many adolescents with sickle cell disease (SCD) experience recurrent and chronic pain, which has a negative impact on their health-related quality of life (HRQL). Cognitive-behavioral therapy (CBT) interventions can lead to improvement in pain and HRQL, yet due to barriers to care, most youth with SCD will not receive these interventions. To address this need for innovative programs targeting youth with SCD pain, we developed iCanCope, a tailored smartphone and web-based program that delivers a pain self-management intervention to youth with SCD. Read More

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http://dx.doi.org/10.1016/j.cct.2018.10.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218943PMC
November 2018
1 Read

Peer support and mobile health technology targeting obesity-related cardiovascular risk in young adults with serious mental illness: Protocol for a randomized controlled trial.

Contemp Clin Trials 2018 Nov 11;74:97-106. Epub 2018 Oct 11.

The Mongan Institute, Massachusetts General Hospital, Cambridge, MA, United States.

Background: Individuals with serious mental illness (SMI) such as schizophrenia and bipolar disorder face a higher risk of early death due to cardiovascular disease and other preventable chronic illnesses. Young adulthood is a critical window of development for lifestyle interventions to improve the long-term health and quality of life in this population. Fit Forward is an NIH-funded randomized clinical trial examining the effectiveness of a group lifestyle intervention (PeerFIT) enhanced with mobile health technology compared to one-on-one mobile lifestyle coaching with Basic Education in fitness and nutrition supported by a wearable Activity Tracking device (BEAT) in achieving clinically significant weight loss and improved cardiorespiratory fitness in young adults with SMI. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183045
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http://dx.doi.org/10.1016/j.cct.2018.10.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6217796PMC
November 2018
4 Reads

Implementing community health worker-patient pairings at the time of hospital discharge: A randomized control trial.

Contemp Clin Trials 2018 Nov 4;74:32-37. Epub 2018 Oct 4.

Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address:

Background: In 2011, there were approximately 3.3 million adult 30-day all-cause hospital readmissions in the US generating $41.3 billion in hospital costs. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183047
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http://dx.doi.org/10.1016/j.cct.2018.09.013DOI Listing
November 2018
3 Reads

A randomised trial of real-time video counselling for smoking cessation in regional and remote locations: study protocol.

Contemp Clin Trials 2018 Nov 2;74:70-75. Epub 2018 Oct 2.

Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305, Australia.

Background: Real-time video communication technology (e.g. Skype) may be an effective mode for delivering smoking cessation treatment to regional and remote residents. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183040
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http://dx.doi.org/10.1016/j.cct.2018.10.001DOI Listing
November 2018
8 Reads

Mobile health intervention for self-management of adolescent chronic pain (WebMAP mobile): Protocol for a hybrid effectiveness-implementation cluster randomized controlled trial.

Contemp Clin Trials 2018 Nov 2;74:55-60. Epub 2018 Oct 2.

Department of Anesthesiology & Pain Medicine, University of Washington School of Medicine, United States; Center for Child Health, Behavior & Development, Seattle Children's Research Institute, United States.

Introduction: Approximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, most youth do not have access to psychological intervention. Our prior studies demonstrate that an existing internet-delivered pain self-management program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183032
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http://dx.doi.org/10.1016/j.cct.2018.10.003DOI Listing
November 2018
2 Reads

A web-based program to improve treatment adherence in patients with type 2 diabetes: Development and study protocol.

Contemp Clin Trials 2018 Nov 2;74:38-45. Epub 2018 Oct 2.

Department of Health Promotion, School CAPHRI, Maastricht University, Maastricht, the Netherlands. Electronic address:

Background: Many patients with type 2 diabetes mellitus (T2DM) sub-optimally adhere to core treatment recommendations, such as healthy diets, sufficient physical activity and pharmacological support. This paper describes the development of the web-based computer-tailored program My Diabetes Profile (MDP), incorporating identified success factors of web-based interventions, and the protocol for testing the effectiveness of this program in a randomized multicentre trial.

Methods: Formative research - including the input of a program committee, qualitative and quantitative studies with patients and health professionals and a literature search - yielded input for the development of the MDP program. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183033
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http://dx.doi.org/10.1016/j.cct.2018.10.002DOI Listing
November 2018
5 Reads

The Anorexia Nervosa Genetics Initiative (ANGI): Overview and methods.

Contemp Clin Trials 2018 Nov 1;74:61-69. Epub 2018 Oct 1.

University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, PO Box 281, SE-171 77 Stockholm, Sweden. Electronic address:

Background: Genetic factors contribute to anorexia nervosa (AN); and the first genome-wide significant locus has been identified. We describe methods and procedures for the Anorexia Nervosa Genetics Initiative (ANGI), an international collaboration designed to rapidly recruit 13,000 individuals with AN and ancestrally matched controls. We present sample characteristics and the utility of an online eating disorder diagnostic questionnaire suitable for large-scale genetic and population research. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183027
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http://dx.doi.org/10.1016/j.cct.2018.09.015DOI Listing
November 2018
20 Reads
1.990 Impact Factor

Community Study of Outcome Monitoring for Emotional Disorders in Teens (COMET): A comparative effectiveness trial of a transdiagnostic treatment and a measurement feedback system.

Contemp Clin Trials 2018 Nov 30;74:18-24. Epub 2018 Sep 30.

University of Connecticut School of Medicine, 65 Kane Street Room 3022, West Hartford, CT 06119, USA.

Emotional disorders, encompassing a range of anxiety and depressive disorders, are the most prevalent and comorbid psychiatric disorders in adolescence. Unfortunately, evidence-based psychosocial therapies typically focus on single disorders, are rarely adopted by community mental health center clinicians, and effect sizes are modest. This article describes the protocol for a comparative effectiveness study of two novel interventions designed to address these challenges. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249684PMC
November 2018

Vitamin D and omega-3 trial to prevent and treat diabetic kidney disease: Rationale, design, and baseline characteristics.

Contemp Clin Trials 2018 Nov 30;74:11-17. Epub 2018 Sep 30.

Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Harvard T.H. Chan School of Public Health, Boston, MA, United States.

Diabetic kidney disease (DKD), defined as reduced glomerular filtration rate (GFR), elevated urine albumin excretion, or both that is clinically attributable to diabetes, is a common and morbid diabetes complication. Animal-experimental data, observational human studies, and short-term clinical trials suggest that vitamin D and omega-3 fatty acid supplements may be safe and inexpensive interventions to reduce the incidence and progression of DKD. The Vitamin D and Omega-3 Trial to Prevent and Treat DKD (VITAL-DKD) was designed as an ancillary study to the VITAL trial of 25,871 US adults. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6203639PMC
November 2018
18 Reads

Working to Increase Stability through Exercise (WISE): Study protocol for a pragmatic randomized controlled trial of a coached exercise program to reduce serious fall-related injuries.

Contemp Clin Trials 2018 Nov 24;74:1-10. Epub 2018 Sep 24.

Penn State College of Medicine, United States.

Approximately one-third of older adults fall each year and fall-related injuries are a leading cause of death and disability among this rapidly expanding age group. Despite the availability of bisphosphonates to reduce fractures, concerns over side effects have dramatically reduced use, suggesting that other treatment options are needed. Though many smaller studies have shown that physical activity programs can reduce falls, no study has been adequately powered to detect a reduction in fall-related injuries. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.006DOI Listing
November 2018

The LURN Research Network Neuroimaging and Sensory Testing (NIST) Study: Design, protocols, and operations.

Contemp Clin Trials 2018 Nov 21;74:76-87. Epub 2018 Sep 21.

Departments of Anesthesiology and Internal Medicine-Rheumatology, University of Michigan, Ann Arbor, MI, United States.

The Neuroimaging and Sensory Testing (NIST) Study of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) is a cross-sectional, case-control study designed to investigate whether disrupted brain connectivity and sensory processing are associated with abnormal lower urinary tract symptoms (LUTS) in patients with overactive bladder syndrome (OAB). The NIST Study tests the hypotheses that patients with urinary urgency will demonstrate: (1) abnormal functional and structural connectivity of brain regions involved in urinary sensation on magnetic resonance imaging (MRI), and (2) hypersensitivity to painful (pressure) and non-painful (auditory) sensory stimuli on quantitative sensory testing (QST), compared to controls. Male and female adults (18 years or older) who present at one of the six participating LURN clinical centers for clinical care of their LUTS, with symptoms of urinary urgency with or without urgency urinary incontinence, are eligible to participate. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6203612PMC
November 2018
3 Reads

Rationale and development of a randomized pragmatic trial to improve diabetes outcomes in patient-centered medical homes serving rural patients.

Contemp Clin Trials 2018 Oct 20;73:152-157. Epub 2018 Sep 20.

Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Highway, Shreveport, LA 71130-3932, USA.

Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that can be readily implemented and sustained in rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on our team developed an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care that includes: 1) the American College of Physicians (ACP) Diabetes Guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change; 2) a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans'); and 3) a training module for health coaches that prepares them to assume educator/counselor roles with the Diabetes Guide as a teaching tool. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6179446PMC
October 2018

Home-based, square-stepping exercise program among older adults with multiple sclerosis: results of a feasibility randomized controlled study.

Contemp Clin Trials 2018 Oct 19;73:136-144. Epub 2018 Sep 19.

Department of Physical Therapy, University of Alabama, Birmingham, United States.

There is very little known about exercise rehabilitation approaches for older adults with multiple sclerosis (MS), yet this growing segment of the MS population experiences declines in cognition and mobility associated with disease progression and aging. We conducted a RCT examining the feasibility of a 12-week, home-based Square-Stepping Exercise (SSE) program in older adults with MS. Older adults with MS (N = 26) with mild-to-moderate levels of disability were recruited and randomized into the intervention (i. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.008DOI Listing
October 2018
1 Read

Optimal treatment for women with a persisting pregnancy of unknown location, a randomized controlled trial: The ACT-or-NOT trial.

Contemp Clin Trials 2018 Oct 20;73:145-151. Epub 2018 Sep 20.

Department of Biostatistics, Yale University School of Public Health, New Haven, CT, United States.

Objective: Pregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, including expectant or active management. Active management can include uterine cavity evacuation or systemic administration of methotrexate. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231403PMC
October 2018
1 Read

Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial.

Contemp Clin Trials 2018 Oct 18;73:123-135. Epub 2018 Sep 18.

Department of Health Behavior and Health Systems, University of North Texas Health Science Center, School of Public Health, Fort Worth, TX, United States.

Background: Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment.

Methods: This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6214814PMC
October 2018
1 Read

Putting patients at the center of kidney care transitions: PREPARE NOW, a cluster randomized controlled trial.

Contemp Clin Trials 2018 Oct 12;73:98-110. Epub 2018 Sep 12.

Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address:

Care for patients transitioning from chronic kidney disease to kidney failure often falls short of meeting patients' needs. The PREPARE NOW study is a cluster randomized controlled trial studying the effectiveness of a pragmatic health system intervention, 'Patient Centered Kidney Transition Care,' a multi-component health system intervention designed to improve patients' preparation for kidney failure treatment. Patient-Centered Kidney Transition Care provides a suite of new electronic health information tools (including a disease registry and risk prediction tools) to help providers recognize patients in need of Kidney Transitions Care and focus their attention on patients' values and treatment preferences. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183029
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http://dx.doi.org/10.1016/j.cct.2018.09.004DOI Listing
October 2018
5 Reads

Improving the cardiometabolic health of people with psychosis: A protocol for a randomised controlled trial of the Physical Health Nurse Consultant service.

Contemp Clin Trials 2018 Oct 9;73:75-80. Epub 2018 Sep 9.

Research Cluster Leader - Muscular and Skeletal Health, School of Health, Medical and Applied Sciences, Central Queensland University, Australia. Electronic address:

Background: Over 690,000 Australians experience psychosis annually, significantly impacting cardiometabolic illness and healthcare costs. Current models of care are fragmented and a critical implementation gap exists regarding the delivery of coordinated physical healthcare for Australians with psychosis.

Objectives: To describe a trial implementing a Physical Health Nurse Consultant (PHNC) role to coordinate physical health care in a community mental health setting. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.001DOI Listing
October 2018
1 Read

Rationale and design of technology assisted stepped collaborative care intervention to improve patient-centered outcomes in hemodialysis patients (TĀCcare trial).

Contemp Clin Trials 2018 Oct 9;73:81-91. Epub 2018 Sep 9.

Renal and Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States. Electronic address:

Most hemodialysis (HD) patients experience symptoms of depression, pain and fatigue that impair their health-related quality of life (HRQOL) significantly. These symptoms are associated with increased hospitalization and mortality, mediated by behavioral factors (e.g. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6168366PMC
October 2018

Evaluating the clinical implementation of structured exercise: A randomized controlled trial among non-insulin dependent type II diabetics.

Contemp Clin Trials 2018 Nov 8;74:25-31. Epub 2018 Sep 8.

Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, California, United States.

Background: The American Diabetes Association (ADA) currently recommends 150 min of moderate-intensity aerobic exercise per week and resistance exercise at least twice per week in individuals with type 2 diabetes (T2DM) to improve overall health [1]. However, approximately 38% of patients with T2DM do not exercise at recommended levels and 31% do not exercise at all [2]. The efficacy of structured exercise interventions has been proven effective in reducing glycosylated hemoglobin A1c (HbA1c) levels in patients, but practical approaches are needed to translate these findings into the clinical setting [3-7]. Read More

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http://dx.doi.org/10.1016/j.cct.2018.09.003DOI Listing
November 2018
1 Read

Design of a randomized controlled trial comparing a mobile phone-based hypertension health coaching application to home blood pressure monitoring alone: The Smart Hypertension Control Study.

Contemp Clin Trials 2018 Oct 29;73:92-97. Epub 2018 Aug 29.

Omron Healthcare Co., Ltd., Kyoto, Japan.

Background: Hypertension is a major cause of morbidity and mortality but frequently remains uncontrolled. A smartphone application that provides coaching regarding home blood pressure monitoring and other aspects of hypertension self-care and related behavior change may be a scalable way to help manage hypertension.

Methods/design: The Smart Hypertension Control Study is a prospective, randomized controlled trial to assess the effects of a hypertension personal control program (HPCP), which consists of an automated artificial intelligence smartphone application that provides individualized support and coaching to promote home monitoring and healthy behavior changes related to hypertension self-management. Read More

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http://dx.doi.org/10.1016/j.cct.2018.08.013DOI Listing
October 2018

Veteran peer Coaches Optimizing and Advancing Cardiac Health (Vet-COACH); design and rationale for a randomized controlled trial of peer support among Veterans with poorly controlled hypertension and other CVD risks.

Contemp Clin Trials 2018 Oct 29;73:61-67. Epub 2018 Aug 29.

VA Puget Sound Healthcare System, General Internal Medicine Service, USA; University of Washington, School of Medicine, Department of Medicine, USA.

Background: Peer support can improve health for patients with chronic conditions; however, evidence for disease prevention is less clear and peer recruitment strategies are not well described. This paper describes a study protocol to evaluate a peer support intervention to improve hypertension control and reduce cardiovascular disease (CVD) risk.

Methods & Research Design: Target enrollment for this two-site study is n = 400. Read More

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http://dx.doi.org/10.1016/j.cct.2018.08.011DOI Listing
October 2018
4 Reads