Leveraging Technology to Address Access and Adherence to Conventional Hospital-Based Pulmonary Rehabilitation in Veterans With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Physical Activity measured as Daily Step Count
研究概览
简要总结
Persons with COPD have significant functional disability but cannot access rehabilitative treatment at hospital-based conventional pulmonary rehabilitation (PR) programs. This project will determine whether an Internet-mediated, pedometer-based walking program can increase physical activity in persons with COPD who qualify for but cannot access PR, compared to usual care. This proposal has high potential to deliver an immediate solution to a pressing clinical need. The proposed research addresses Rehabilitation R&D Service's current priority area of improving disabled Veterans' health-related quality of life by reducing disease burden and maximizing functional recovery.
详细描述
Conventional pulmonary rehabilitation (PR) programs are highly effective and the standard of care in patients with chronic obstructive pulmonary disease (COPD). PR faces two significant problems: (1) most patients with COPD who would benefit from PR cannot access it, and 2) there is no effective long-term strategy to maintain physical activity (PA) and benefits after completing PR. The investigators propose a randomized controlled trial (RCT) to test the efficacy of a technology-mediated intervention to increase PA in persons with COPD who qualify for but cannot access conventional, hospital-based PR. COPD is a leading cause of death in the United States; an estimated 16 million Americans have COPD. Despite maximal medical therapy, patients with COPD characteristically experience breathlessness, which leads to a downward spiral of sedentary behavior, physical inactivity, deconditioning, and functional disability. Low physical activity is associated with poor outcomes in COPD--increased risk of acute exacerbations, hospitalizations, and death, independent of lung function. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend regular PA for all patients with COPD. Conventional, supervised PR programs clearly reduce breathlessness, and improve health-related quality of life (HRQL) and exercise capacity. However, PR programs face significant challenges of access and adherence. The investigators developed Every Step Counts (ESC), a technology-mediated intervention based on the Behavioral Theory of Self-Regulation, to target sedentary behavior, promote PA, and alleviate deconditioning. ESC couples a website with a pedometer to directly monitor step counts. The website provides individualized step-count goals, iterative feedback, education on disease self-management, motivation, and an online community of social support. In two randomized studies in Veterans with COPD, the investigators demonstrated ESC's safety, feasibility, and efficacy to increase PA. Accessible via the internet and available at any time from home, ESC could be an ideal low-cost platform to address the limitations of conventional PR. The investigators hypothesize that ESC may be an efficacious strategy to promote PA in the many patients who cannot attend a PR program.
Primary Aim 1: Determine the efficacy of a web-based intervention, ESC, to increase PA (measured directly with an accelerometer and a questionnaire that assesses intensity), compared to usual care, in persons with COPD who are referred to or eligible for conventional PR but who cannot access it.
Secondary Aim 2: Estimate the effect of the ESC intervention on (a) exercise self-efficacy, (b) HRQL, (c) dyspnea, (d) depression, and (e) risk of acute exacerbations and COPD-related hospitalizations, compared to usual care.
All study visits are performed either in-person or remotely starting September, 2021.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study staff communicating randomization assignments to subjects will be different from study staff conducting follow-up outcome assessments.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, greater than or equal to 40 years of age
- •Clinical diagnosis of COPD defined as either a ratio of FEV1 to forced vital capacity (FVC) < 0.70 or chest CT evidence of emphysema or prior documentation of FEV1/FVC ratio of < 0.7 and clinical evidence of COPD
- •defined as 10 pack-year cigarette smoking history
- •or on bronchodilators
- •Have declined participation in or cannot access a conventional pulmonary rehabilitation program
- •Medical clearance from healthcare provider to participate in an exercise program
- •Have access to a computer with Internet connection, a USB port or Bluetooth capability, and Windows XP/Vista/7/8/10 or higher, or Mac OSX 10.5 or higher operating system, or willing to come to VA Medical Center to use study computers
- •Competent to provide informed consent
- •Willingness to make return visits and be available by telephone for duration of study
排除标准
- •COPD exacerbation in the previous 1 month
- •Inability to ambulate with or without assistance (if remote)
- •On supplemental oxygen (if remote)
- •Use of walking assistive device (if remote)
- •Inability to complete questionnaires
- •Inability to collect at least 7 of 10 days of baseline step counts
- •Participation in a pulmonary rehabilitation program at time of screening or within the previous 3 months
- •Participation in another exercise-related research study at time of screening
- •Plans to participate in an exercise-related research study in the next 3 months
- •Average baseline step counts of greater than or equal to 10,000 steps per week
结局指标
主要结局
Physical Activity measured as Daily Step Count
时间窗: 12 weeks
Daily Step Count directly measured with a monitoring device.
次要结局
- Amount of Depression experienced by the participant(12 weeks and 6 months)
- Exercise Self-Regulatory Efficacy(12 weeks)
- Health-Related Quality of Life using a disease specific questionnaire(12 weeks)
- Shortness of Breath rating as perceived by the participant(12 weeks)
- Healthcare Utilization represented by number of Acute Exacerbations and Hospitalizations over timeframe(12 weeks)