Improving QoL in Outpatients with Heart Failure: A Dose-Finding Study and RCT

改善心力衰竭门诊患者的生活质量：剂量探索研究和随机对照试验

• 批准号: 9210510
• 负责人: Jonathan A Shaffer
• 金额: $ 12.3万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-02-01 至 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9210510
• 关键词: Abbreviations; Address; American; Attention; Beck depression inventory; Behavior Therapy; Behavioral; Cardiac; Cardiomyopathies; Cardiopulmonary; Cardiovascular Diseases; Caring; Chronic Disease; Cities; Client satisfaction; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Clostridium perfringens epsilon toxin; Cognitive Therapy; Complex; Data; Development Plans; Disease Management; Dose; Economics; Educational process of instructing; Epidemiology; Evidence based treatment; Exercise Physiology; Exercise stress test; Functional disorder; Goals; Health Psychology; Heart; Heart failure; Hospitalization; Incidence; Intervention; K-Series Research Career Programs; Kansas; Master' s Degree; Mediating; Medical; Mental Depression; Mentors; Methods; Modeling; Morbidity - disease rate; New York; Observational Study; Outcome; Outpatients; Oxygen Consumption; Participant; Patient-Focused Outcomes; Patients; Pharmacotherapy; Physical Function; Physical activity; Practice Guidelines; Prevalence; Primary Health Care; Problem Solving; Program Evaluation; Quality of life; Quality-of-Life Assessment; Questionnaires; Randomized; Randomized Controlled Trials; Recommendation; Research; Research Project Grants; Self Efficacy; Staging; Structure; Symptoms; Telephone; Testing; Time Management; Training; United States; Universities; Walking; actigraphy; arm; cardiovascular health; career; career development; clinical care; clinically significant; cohort; cost; depressive symptoms; design; exercise capacity; follow-up; functional improvement; health care service utilization; improved; mortality; multidisciplinary; patient oriented research; primary outcome; problem solving therapy; programs; psychological distress; reduce symptoms; research data dissemination; screening; skills; tertiary care; theories

DESCRIPTION (provided by applicant): The proposed K23 Career Development Award will enable Dr. Jonathan Shaffer to establish an independent research career with expertise in behavioral interventions for patients with heart failure (HF). Dr. Shaffer is a clinical psychologit whose long-term goal is to optimize a behavioral intervention to improve functional and cardiac outcomes for patients with HF, but further training is required to accomplish this goal. As such, he has assembled a multidisciplinary team of mentors to provide training in: (1) clinical trial design and conduct; (2) the pathophysiology, management, epidemiology, and exercise physiology of HF; (3) quantitative methods for dose estimation and randomized controlled trials (RCT); (4) clinical health psychology theories and practice; and (5) research dissemination. The career development plan includes completion of a Master's degree in Patient-Oriented Research from Columbia University. For his research project, Dr. Shaffer will conduct a dose- finding study and RCT of Problem-Solving Therapy (PST) for outpatients with HF and reduced quality of life (QoL). Previous research has shown that QoL is often severely diminished among HF patients, and that reduced QoL predicts mortality and morbidity. Given the mixed findings of previous trials, the minimal focus on QoL as a primary endpoint, and recommendations to consider QoL as part of high-quality clinical care, there is a need for new interventions to improve QoL for HF patients. Moreover, the complexity and financial burden of routine pharmacotherapy for HF suggest a need for new non-pharmacologic interventions. This proposal consists of two interrelated studies that together will determine the feasibility and patient acceptance of telephone-delivered PST for outpatients with stable HF and reduced QoL. Study 1 is a dose-finding study to determine the minimally effective dose (MED; in number of sessions) of telephone-delivered PST needed to produce a clinically significant QoL improvement over 8 weeks. PST will be administered to 48 participants in cohorts of 3, and the MED will be determined using the Continual Reassessment Method. Study 2 is a two-arm RCT of 44 additional participants who will be randomized in a 1:1 ratio to PST or Time Management. Study 2 is adequately powered to determine whether the MED of PST is associated with greater improvements in peak VO2 over 8 weeks compared to Time Management. Study 2 will also evaluate the efficacy of PST versus Time Management with respect to QoL, self-efficacy, depression, daily physical activity, and distance walked during a 6-minute walk test (6MWT). A 6MWT and cardiopulmonary exercise testing will be conducted at baseline and at 8 weeks. QoL, depression, and self-efficacy will be assessed at baseline, 4, 8, and 12 weeks (and additionally at 16 and 20 weeks for Study 2). Actigraphy-assessed daily activity will be recorded throughout the intervention and follow-up period. Dr. Shaffer will use these data to design larger RCTs for subsequent R01 applications with power of 0.90 comparing PST to Time Management with QoL and cardiac outcomes as primary endpoints. These data will also inform his larger program of research on HF.

描述（由申请人提供）：拟议的 K23 职业发展奖将使 Jonathan Shaffer 博士能够建立独立的研究生涯，在心力衰竭 (HF) 患者的行为干预方面拥有专业知识。 Shaffer 博士是一位临床心理学家，其长期目标是优化行为干预，以改善心力衰竭患者的功能和心脏结局，但需要进一步的培训才能实现这一目标。因此，他组建了一支多学科导师团队，提供以下方面的培训：（1）临床试验设计和实施； (2) 心力衰竭的病理生理学、治疗、流行病学和运动生理学； （3）剂量估计和随机对照试验（RCT）的定量方法； （4）临床健康心理学理论与实践； (5) 研究传播。职业发展计划包括完成哥伦比亚大学以患者为导向的研究硕士学位。在他的研究项目中，Shaffer 博士将为患有心力衰竭且生活质量 (QoL) 降低的门诊患者进行剂量探索研究和问题解决疗法 (PST) 的随机对照试验。先前的研究表明，心力衰竭患者的生活质量往往严重下降，而生活质量的下降预示着死亡率和发病率。鉴于先前试验的结果好坏参半，对生活质量作为主要终点的关注程度最低，以及将生活质量视为高质量临床护理一部分的建议，需要采取新的干预措施来改善心力衰竭患者的生活质量。此外，心力衰竭常规药物治疗的复杂性和经济负担表明需要新的非药物干预措施。该提案由两项相互关联的研究组成，共同确定对稳定心力衰竭和生活质量下降的门诊患者进行电话 PST 的可行性和患者接受度。研究 1 是一项剂量探索研究，旨在确定在 8 周内产生临床显着的生活质量改善所需的电话传递 PST 的最低有效剂量（MED；以会话次数计）。 PST 将以 3 人为一组对 48 名参与者进行，MED 将使用持续重新评估方法确定。研究 2 是一项双臂随机对照试验，纳入了 44 名额外参与者，这些参与者将以 1:1 的比例随机分配到 PST 或时间管理组。研究 2 足以确定与时间管理相比，PST 的 MED 是否与 8 周内峰值摄氧量的更大改善相关。研究 2 还将评估 PST 与时间管理在生活质量、自我效能、抑郁、日常体力活动以及 6 分钟步行测试 (6MWT) 中步行距离方面的效果。将在基线和第 8 周时进行 6MWT 和心肺运动测试。将在基线、第 4、8 和 12 周（以及研究 2 的第 16 和 20 周）评估生活质量、抑郁和自我效能。在整个干预和随访期间将记录体动记录仪评估的日常活动。 Shaffer 博士将使用这些数据为后续 R01 应用设计更大的 RCT，将 PST 与时间管理进行比较，以 QoL 和心脏结果作为主要终点，功效为 0.90。这些数据还将为他更大的心力衰竭研究计划提供信息。