A novel behavioral intervention to promote adherence in heart failure

一种促进心力衰竭患者依从性的新型行为干预

基本信息

批准号：
10292856
负责人：
Christopher M Celano
金额：
$ 80.09万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-01 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10292856
关键词：
Accelerometer Adherence Affect Algorithms Ambulatory Care Facilities American Anxiety Attention Behavior Behavior Therapy Blood Pressure Body mass index Cardiac Cardiac health Cardiac rehabilitation Cardiology Cardiovascular system Chronic Clinical Clinical Trials Complex Control Locus Counseling Diagnosis Diet Disease Progression Event Fostering Foundations Glucose Goals Health Health behavior Healthcare Heart Heart failure Hospitalization Impaired health Impairment Individual Intake Intention Intervention Letters Lipids Logistics Measures Medical Mental Depression Mental Health Minority Modeling Monitor Motivation New York Outcome Outcome Study Patients Personal Satisfaction Pharmaceutical Preparations Physical activity Population Psychological Factors Psychology Quality of life Randomized Randomized Clinical Trials Regimen Research Self Care Self Efficacy Sodium Sodium-Restricted Diet Standardization Symptoms System Telephone Testing Text Messaging Time Treatment Efficacy Treatment Failure United States National Institutes of Health Well in self Writing base behavior change behavioral adherence cardiovascular disorder risk cardiovascular health comorbidity dietary adherence efficacy evaluation efficacy testing flexibility functional outcomes good diet gratitude health related quality of life heart disease risk high risk population hospital readmission improved innovation intervention effect medication compliance moderate-to-vigorous physical activity mortality motivational enhancement therapy novel optimism pill pilot trial primary outcome programs prospective psychologic psychological outcomes randomized trial skills urinary

项目摘要

Heart failure (HF) affects nearly 6 million Americans and leads to significant impairments in functioning, quality of life, and survival. Health behaviors (e.g., physical activity, low-sodium diet, medications) are associated with improved health, including survival, in HF, but most HF patients do not adhere adequately to these behaviors. Existing health behavior programs have had limited impact on adherence and cardiac outcomes, are inaccessible to many patients, and do not target psychological factors independently associated with heart health. Motivational interviewing- (MI-) based programs have been shown to increase engagement in HF self-care behaviors but may not be sufficient to improve downstream health outcomes in HF patients. Positive psychology (PP), which utilizes systematic activities (e.g., using strengths, expressing gratitude) to cultivate well-being, may be an important component of a health behavior program in HF. Positive psychological constructs are prospectively and independently associated with both health behavior adherence and improved cardiovascular health, and PP interventions have been shown to improve these constructs and increase health behavior adherence in patients with or at risk for cardiovascular disease. Furthermore, PP could be combined with MI to promote self-efficacy, motivation, and intention to engage in health behaviors. We recently completed a multi-stage project (REACH for Health) to develop a 12-week, telephone- delivered, combined positive psychology-motivational interviewing (PP-MI) intervention to promote physical activity, diet, and medication adherence in HF. We now aim to examine the efficacy of this program, with additional twice weekly PP and health behavior text messages for a total of 24 weeks, compared to an MI- based educational control condition, in an NIH Stage II, randomized clinical trial in 280 patients with New York Heart Association class I-III HF and suboptimal adherence to physical activity, diet, or medications. The primary study outcome will be change in objectively measured health behavior adherence (composite outcome of moderate to vigorous physical activity [measured via accelerometer], sodium intake [24h urinary sodium], and medication adherence [Medication Event Monitoring System electronic pill bottle]), and we hypothesize that PP-MI will lead to greater improvements in adherence compared to the MI-based educational condition. We also will measure the intervention’s impact on psychological health, quality of life, functional outcomes, markers of cardiovascular health (e.g., body mass index, lipids, glucose), and major adverse cardiac events. We will utilize our team’s expertise in clinical trials, cardiology, and PP- and MI-based interventions to effectively and efficiently perform the proposed trial, which—consistent with the goals of PA-18-722—aims to “test [an] innovative approach…for maintaining individuals’…adherence to complex health care regimens.” If effective, we will examine the intervention’s effects on cardiovascular health outcomes in a larger trial and will begin to explore ways to implement this potentially highly scalable intervention in clinical settings.

心力衰竭（HF）影响近600万美国人，并导致功能障碍，生活质量和生存。健康行为（例如体育锻炼，低钠饮食，药物）是与HF中的健康相关，包括生存，包括生存，但大多数HF患者并未适当遵守这些行为。现有的健康行为计划对依从性和心脏的影响有限结果，许多患者无法访问，并且不针对独立相关的心理因素与心脏健康。励志采访 - 基于基于的（MI-）计划可以增加参与度在HF自我保健行为中，但可能不足以改善HF患者的下游健康结果。积极心理学（PP），利用系统活动（例如，使用优势，表达感激）要培养幸福感，这可能是HF健康行为计划的重要组成部分。积极的心理结构前瞻性和独立地与健康行为遵守并改善了心血管健康和PP干预措施可改善这些结构，并且增加患有或处于心血管疾病风险的患者的健康行为依从性。此外，pp 可以与MI结合起来，以促进自我效能，动力和参与健康行为的意图。我们最近完成了一个多阶段项目（健康范围），以开发一个为期12周的电话 - 交付积极的心理动机访谈（PP-MI）干预以促进身体 HF的活动，饮食和药物依从性。现在，我们旨在研究该计划的效率，并与MI-I-Mi相比基于NIH II期的基于教育控制条件，280例纽约患者的随机临床试验心脏协会I-III级HF和次优遵守体育锻炼，饮食或药物。这基本研究结果将在客观测量的健康行为依从性（综合结果）中改变中度至剧烈的体育活动[通过加速度计测量]，钠摄入量[24h尿钠]，和药物依从性[药物监测系统电子药瓶]），我们假设与基于MI的教育条件相比，PP-MI将导致依从性的改善。我们还将衡量干预对心理健康，生活质量，功能结果的影响，心血管健康的标记（例如体重指数，脂质，葡萄糖）和重大的不良心脏事件。我们将利用团队在临床试验，心脏病学以及基于PP和MI的干预措施方面的专业知识有效，有效地执行拟议的试验，该试验与PA-18-722的目标相吻合 - “测试一种创新的方法……用于维持个人……遵守复杂的医疗保健方案。”如果有效，我们将在更大的试验中检查干预措施对心血管健康结果的影响，并将开始探索在临床环境中实施这种潜在的高度可扩展干预措施的方法。