Home-Based Health Management of COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Change in Number of Daily Steps Between the Intervention and Control Conditions
研究概览
简要总结
Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete home exercise as part of pulmonary rehabilitation (PR). The proposed system has two components: home-based activity monitoring and health coaching. The investigators will conduct a randomized, wait-list controlled clinical study to evaluate the effects of the activity monitoring system and health coaching on quality of life and daily steps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •diagnosis of GOLD stage II, III, or IV COPD
- •current or previous smoker with at least 10 pack-years of cigarette smoking
- •be hospitalized for an exacerbation of COPD
排除标准
- •high likelihood of being lost to follow-up or contact
- •inability to provide good data or follow commands
- •inability to do mild exercise
结局指标
主要结局
Change in Number of Daily Steps Between the Intervention and Control Conditions
时间窗: Steps measured at baseline (week 1) and week 9
Number of daily steps as measured by the SenseWear Pro ArmBand, which is an accepted criterion measure for daily physical activity in adults with Chronic Obstructive Pulmonary Disease.
Change in Physical Quality of Life Between the Intervention and Control Conditions
时间窗: Quality of Life measured at baseline (week 1) and week 9
Measure Description: The Chronic Respiratory Disease Questionnaire measures physical and emotional aspects with 20 items in four domains/categories. The two domains/categories used for physical summary were dyspnea and fatigue. The items are assessed numerically on a 7-point modified Likert scale (from 1 to 7). Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. Physical quality of life is obtained by adding the fatigue and dyspnea scores and dividing by two; hence, the score range is from 1 to 7. Higher scores indicate better health-related quality of life. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more.
次要结局
未报告次要终点
研究者
Sara Seifert
President
Minnesota HealthSolutions