A Randomized Controlled Trial to Reduce Hopelessness through Enhanced Physical Activity in Adults with Ischemic Heart Disease

一项通过增强缺血性心脏病成人体力活动来减少绝望的随机对照试验

• 批准号: 10178175
• 负责人: SUSAN L DUNN
• 金额: $ 15.99万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10178175
• 关键词: Accelerometer; Adult; Adverse event; Anxiety; Behavioral; COVID-19; COVID-19 pandemic; Cardiac rehabilitation; Caring; Cessation of life; Characteristics; Chronic Disease; Climacteric; Communities; Containment; Coronavirus; Data; Data Collection; Diagnosis; Effectiveness; Emotional; Employment; Enrollment; Equipment and supply inventories; Event; Exercise; Extended Family; Feeling hopeless; Feeling suicidal; Food; Funding; Future; Goals; Health; Health Professional; Health behavior; Healthcare; Heart; Heart Diseases; Home environment; Hospitals; Income; Individual; Informal Social Control; Institutional Review Boards; Intervention; Investments; Knowledge; Lead; Life; Link; Measures; Mediating; Medical; Mental Depression; Mental Health; Midwestern United States; Morbidity - disease rate; Motivation; Multi-Ethnic Study of Atherosclerosis; Myocardial Infarction; Myocardial Ischemia; Nurses; Outcome; Parents; Participant; Patient Care; Patients; Personal Satisfaction; Persons; Physical Function; Physical activity; Populations at Risk; Positioning Attribute; Protocols documentation; Psyche structure; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Reporting; Research; Science; Self Determination; Self Management; Shelter facility; Social Distance; Social support; Stress; Stress and Coping; Symptoms; Teaching Hospitals; Telephone; Testing; Time; United States National Institutes of Health; Videoconferencing; Vulnerable Populations; Work; actigraphy; arm; attentional control; base; behavioral health; comparative; effectiveness testing; high risk; high risk population; improved; innovation; instrument; longitudinal design; mHealth; moderate-to-vigorous physical activity; mortality; mortality risk; motivational intervention; pandemic disease; programs; public health emergency; response; social; symposium; theories; therapy design; three-arm study; trait; treatment arm

ABSTRACT (R01-funded parent RCT) Hopelessness is associated with a 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27–52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. Low levels of PA independently contribute to increased death and adverse events in patients with IHD. Rates of PA in IHD patients continue to be unacceptably low in both hospital-based cardiac rehabilitation and home settings. Hopelessness frequently compounds this issue. The links among hopelessness, PA, and mortality and morbidity for patients with IHD remain unknown. While research has investigated strategies to increase PA among IHD patients in general, we are the only group to design an intervention to promote PA specifically in hopeless IHD patients. Our work, based on Self Determination Theory and Cohen’s Stress and Coping Social Support Theory, has shown feasibility and preliminary efficacy for a motivational intervention that integrates social support from both the patient’s nurse and significant other to promote increased PA. The purpose of this randomized controlled trial is to establish the effectiveness of our 6-week mHealth intervention (Heart Up!) to promote increased PA in hopeless patients with IHD. We will enroll 225 hopeless IHD patients from a large community teaching hospital in the Midwest. Patients will be randomized (75 per group) to one of three groups: 1) motivational social support (MSS) from a nurse, 2) MSS from a nurse with additional significant other support (SOS), or 3) attention control (AC). Data will be collected at baseline, 8 and 24 weeks using an accelerometer for PA and valid and reliable instruments of physical and emotional health and behaviors. The specific aims are to: 1) test the effectiveness of 6 weeks of MSS and MSS with SOS on increasing mean minutes per day of moderate to vigorous PA, measured by an ActiGraph accelerometer; 2) determine the effects of change in minutes per day of moderate to vigorous PA on state hopelessness, measured by the State-Trait Hopelessness Scale; and 3): determine if social support (measured by the ENRICHD Social Support Inventory) and motivation (measured by the Exercise Self- Regulation Questionnaire) mediate the effects of the Heart Up! intervention on PA. The findings from this study could transform care for IHD patients who are hopeless by promoting self-management of important PA goals that can contribute to better health outcomes. This proposal supports NINR’s investment in self-management to improve the quality of life for individuals with chronic illness.

摘要（R 01资助的母RCT） 绝望与死亡率或非致命性心肌梗死风险增加3.4倍相关， 缺血性心脏病（IHD）患者，独立于抑郁症。绝望被认为是 27-52%的IHD患者在出院后可持续长达12个月。绝望，a 对未来的消极看法和无助感，可能是对事件（状态）的暂时反应 或习惯性的观点（特质）。绝望与身体功能下降和身体机能下降有关。 活动（PA）水平与IHD的个人。低水平的PA独立地导致死亡增加， IHD患者的不良事件。IHD患者中PA的发生率在两组中仍然低得不可接受， 以医院为基础的心脏康复和家庭环境。绝望常常使这个问题复杂化。的 IHD患者的绝望、PA和死亡率及发病率之间的联系尚不清楚。而 研究调查了增加IHD患者PA的策略，我们是唯一一组 设计干预措施，特别是在无望的IHD患者中促进PA。我们的工作，基于自我 决心理论和科恩的压力和应对社会支持理论，已显示出可行性， 动机干预的初步疗效，整合了来自患者护士和 和显著其他促进PA增加。这项随机对照试验的目的是建立 我们为期6周的移动健康干预措施的有效性（Heart Up！）促进无望患者的PA增加 关于IHD我们将从中西部的一家大型社区教学医院招募225名无望的IHD患者。 将患者随机（每组75人）分为三组：1）来自一个社区的动机性社会支持（MSS）， 护士，2）来自护士的MSS与其他重要支持（SOS），或3）注意力控制（AC）。数据 将在基线、第8周和第24周使用PA加速计和有效可靠的仪器收集 身体和情绪健康和行为。具体目的是：1）测试6周的有效性 MSS和MSS伴SOS对中度至剧烈PA每天平均分钟数增加的影响，通过 ActiGraph加速计; 2）确定中度至剧烈PA每天分钟数变化对 状态绝望，通过状态-特质绝望量表测量;和3）：确定社会支持是否 （由ENRICHD社会支持量表测量）和动机（由锻炼自我测量） 调节问卷）介导的影响，心脏了！介入PA。这项研究的结果 通过促进重要PA目标的自我管理，可以改变对无望的IHD患者的护理 可以促进更好的健康结果。该提案支持NINR在自我管理方面的投资 改善慢性病患者的生活质量。