Heart Failure Activity Coach Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CareLigo AB
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Study design
研究概览
简要总结
An application (app) called the activity coach will be tested to see if it can increase physical activity and decrease sedentary behaviuor, as well as increase quality of life and lead to personal goal attainment in physically inactive heart failure (HF) patients. This pilot randomized controlled trial (RCT) will test the study design and recruitment process, as well as outcomes for a future efficacy RCT.
HF-patients equipped with the mHealth-tool Optilogg will be screened for physical inactivity and then recruited and randomized to either have the activity coach app added to their Optilogg or remain with the standard Optilogg. The study will go on for 12 weeks. Weeks 1 and 12 physical activity using an accelerometer will be recorded, as well as health-related quality of life. At the start of the study the patients will list goals relating to physical activity which the wish to attain, and the level of attainment will be evaluated at the end of the study.
The activity coach educated the patient about physical activity, offers means of manually tracking physical activity, and provides trends of registered activity. Furthermore, it provides weekly summaries of registered physical activity and provides means of setting goals for the following week.
详细描述
Study design:
---------------- The activity coach is to be developed using a scientific approach based on the Medical Research Council guidelines, including a small pilot (ethical approval Dnr 2020-01444) which is to be published separately.
This is the first step and the second step is the randomized controlled pilot study (pilot-RCT), to be performed in a primary care setting in Sweden (ethical approval Dnr 2021-05366-01). The purpose is to test the newly developed application (app) called the activity coach, to see if it can improve physical activity, health and quality of life in physically inactive hert failure (HF) patients, but more importantly test the study design and recruitment process, as well as outcomes for a future efficacy RCT.
The patients included will already be equipped with the mHealth tool Optilogg, and then screened for physical inactivty through a self-report question (Blomqvist, 2020, ESC Heart Fail, Utility of single-item questions to assess physical inactivity in patients with chronic heart failure), and then randomized to either receive or not receive the activity coach app.
After randomization the patients will be equipped with an accelerometer for one week. The intervention will go on for 12 weeks, and week twelve the patients will once again carry an acceleroemter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed heart failure
- •Equipped with Optilogg
- •Physically inactive (screening)
排除标准
- •Does not consent to using accelerometer
- •Does not consent to home-visit
- •Current participation in another study relating to physical activity
- •Life-expectancy less than six months
结局指标
主要结局
Study design
时间窗: 12 weeks
Analyze the number of patients needed to be screened to find appropriate and willing participants for the study.
次要结局
- Physical activity(12 weeks)
- Kansas City Cardiomyopathy Questionnaire(12 weeks)
- Sedentary time(12 weeks)
- Goal attainment score(12 weeks)