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职业发展奖将使乔纳森·沙弗（Jonathan Shaffer）博士能够建立独立的研究职业，具有心力衰竭患者（HF）的行为干预方面的专业知识。 Shaffer博士是一种临床心理学，其长期目标是优化行为干预措施，以改善HF患者的功能和心脏结局，但需要进一步培训才能实现这一目标。因此，他组建了一个多学科的导师团队，以提供以下方面的培训：（1）临床试验设计和行为； （2）HF的病理生理，管理，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和实践； （5）研究传播。职业发展计划包括哥伦比亚大学以患者为导向研究的硕士学位。对于他的研究项目，Shaffer博士将对HF和生活质量降低（QOL）进行剂量发现研究和解决问题疗法的RCT（PST）。先前的研究表明，HF患者的QOL通常会严重减少，这降低了QOL预测死亡率和发病率。鉴于先前试验的发现混合的结果，最少关注QOL作为主要终点，并建议将QOL视为高质量临床护理的一部分，因此需要采取新的干预措施来改善HF患者的QOL。此外，HF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，这些研究将共同​​确定稳定的HF和QoL稳定的门诊患者的可行性和患者接受。研究1是一项剂量调查研究，旨在确定在8周内产生临床意义的QoL改善所需的电话传递的PST的最小有效剂量（MED；数量）。 PST将对48名参与者进行3的参与者，并将使用持续的重新评估方法确定MED。研究2是另外44名参与者的两臂RCT，他们将以1：1的比例与PST或时间管理进行随机分配。研究2与时间管理相比，在8周内，PST的MED在8周内的峰值VO2的改善是否更大。研究2还将评估PST与时间管理在QOL，自我效能感，抑郁，每日体育锻炼以及在6分钟步行测试（6MWT）期间步行的疗效。将在基线和8周时进行6MWT和心肺运动测试。 QOL，抑郁和自我效能感将在基线，4、8和12周（以及研究2的16和20周）进行评估。在整个干预期间和随访期间，将记录由动作法评估的日常活动。 Shaffer博士将使用这些数据来设计较大的RCT，以用于随后的R01应用，功率为0.90，将PST与QOL和心脏结果作为主要终点，将PST与时间管理与时间管理进行比较。这些数据还将告知他对HF的更大研究计划。