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 · Jul 2015
Multicenter StudyLipiodol lOcalization for Ground-glass opacity mInimal Surgery: Rationale and design of the LOGIS trial.
The diagnosis and treatment of ground-glass opacity (GGO) lesions have become important issues because subsolid nodules including GGO are known to frequently represent the histologic spectrum of lung adenocarcinoma. Because small GGO lesions cannot usually be palpated or visualized during surgery, several marking techniques have been reported for localization during thoracoscopic surgery, such as lipiodol and hook-wire localization. This study is designed to demonstrate the usefulness and safety of the lipiodol localization technique for individuals undergoing GGO VATS resection compared to the hook-wire localization technique. ⋯ If the aims of this study are achieved, then the use of lipiodol localization technique will be widespread in the localization of non-palpable pulmonary lesions that are indicated for surgical resection. (ClinicalTrials.gov: NCT02180568).