Contemporary clinical trials
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Contemp Clin Trials · Jul 2015
Randomized Controlled Trial Multicenter StudyFAmily CEntered (FACE) advance care planning: Study design and methods for a patient-centered communication and decision-making intervention for patients with HIV/AIDS and their surrogate decision-makers.
Although the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) has become a chronic illness, disease-specific advance care planning has not yet been evaluated for the palliative care needs of adults with HIV/AIDS. This prospective, longitudinal, randomized, two-arm controlled clinical trial aims to test the efficacy of FAmily CEntered advance care planning among adults living with AIDS and/or HIV with co-morbidities on congruence in treatment preferences, healthcare utilization, and quality of life. The FAmily CEntered intervention arm is two face-to-face sessions with a trained, certified facilitator: Session 1) Disease-Specific Advance Care Planning Respecting Choices Interview; Session 2) Completion of advance directive. ⋯ We hypothesize that this intervention will enhance patient-centered communication with a surrogate decision-maker about end of life treatment preferences over time, enhance patient quality of life and decrease health care utilization. We further hypothesize that this intervention will decrease health disparities for Blacks in completion of advance directives. If proposed aims are achieved, the benefits of palliative care, particularly increased treatment preferences about end-of-life care and enhanced quality of life, will be extended to people living with AIDS.
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Contemp Clin Trials · Jul 2015
Randomized Controlled Trial Multicenter StudyResearch aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial.
Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. ⋯ We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE's cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated-through a new model of accessible and integrative lifestyle medicine and mental health expertise-in primary care.
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Contemp Clin Trials · Jul 2015
Randomized Controlled Trial Multicenter StudyRationale and design of the RT-AF study: Combination of rivaroxaban and ticagrelor in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention.
Optimal antithrombotic strategy for patients with concomitant coronary artery disease and atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) is still controversial, and the role of novel antithrombotic agents has nerve been tested. Therefore, the aim of this study is to evaluate and overall safety and efficacy profile of the combination of rivaroxaban and ticagrelor in this particular population. ⋯ The study will be sufficiently powered to provide data primarily regarding the safety of dual therapy with rivaroxaban and ticagrelor over the traditional triple therapy in patients with AF undergoing PCI at 12 months. It will also provide important information regarding the efficacy of the two different antithrombotic regimens. (ClinicalTrials.gov identifier: NCT02334254).
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Contemp Clin Trials · May 2015
Randomized Controlled TrialMenstrual pain and quality of life in women with primary dysmenorrhea: Rationale, design, and interventions of a randomized controlled trial of effects of a treadmill-based exercise intervention.
Dysmenorrhea in the absence of pelvic abnormality is termed primary dysmenorrhea (PD). The health burden and social and economic costs of PD are high as it is reported to be the leading cause of recurrent absenteeism from school or work in adolescent girls and young adults. The belief that exercise works for relieving symptoms in women with PD is based on anecdotal evidence and non-experimental studies. ⋯ The secondary outcomes of the study are quality of life, functional limitation, sleep, global improvement with treatment, and protocol adherence. The outcomes assessments are done at first menstrual period (baseline, Week 0), 2nd menstrual period (Week 4) and at two additional time points (Week 16 and Week 28) during the trial. The results of the study will provide physiotherapists, medical practitioners, and researchers as well as the women who have PD with new insights, knowledge, and evidence about the use of exercise to manage pain in women with PD.
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Contemp Clin Trials · May 2015
Randomized Controlled TrialDoes cognitive behavioral therapy strengthen the effect of bariatric surgery for obesity? Design and methods of a randomized and controlled study.
(Extreme) obesity is a chronic harmful condition with high risk of medical comorbidities and negative social and emotional consequences. Bariatric surgery is an effective intervention for obesity, but approximately 20 to 30% of the patients experience adverse outcomes after surgery and there is a need for augmentation of current treatment strategies. This study examines the added value of pre-operative cognitive behavioral therapy (CBT) focused on modification of thoughts and behaviors in terms of eating behavior and physical exercise as well as preparation for surgery and postoperative life style. We hypothesize that pre-operative CBT will result in better weight loss maintenance, reduction of maladaptive eating behavior and better adherence to postoperative lifestyle on the long term as compared to bariatric surgery alone. ⋯ One hundred and twenty eight patients that are on a waiting list for bariatric surgery are randomly assigned to the control or treatment condition. Patients in the treatment condition receive 10 sessions of CBT before surgery aimed at modifying dysfunctional eating habits and behaviors and developing more rational weight and body-related beliefs in order to enable long term maintenance of a healthier lifestyle after surgery. Weight loss, eating behavior, eating disorders, depression, quality of life and psychological distress are assessed before and after treatment, as well as 1, 3, and 5 year following surgery.