Future Patient - Telerehabilitering af Patienter Med Hjertesvigt II
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Health-related quality of life
研究概览
简要总结
The aim of the study is to test and evaluate the use of video consultations and an algorithm for weight gain and loss in the Future Patient Telerehabilitation program for HF patients in an RCT.
详细描述
Next steps The Future Patient study - telerehabilitation of HF patients II
Based on the preliminary results from FP I (being published fall 2020) and a review of literature, the investigators would like to improve our telerehabilitation program and technologies in order to prepare for implementation of the FTP and technologies.
- The HF patients in FP I expressed that the KCCQ was too long when having to complete the questionnaire every other week. Therefore, the investigators would like to test a shorter questionnaire HeartQoL (ESC) as a patient-reported outcome tool every month.
- Video consultations instead of physical meetings with doctors and nurses at the hospital. Currently, there is a lack of evidence regarding the use of video to decrease physical visits at the hospitals instead of video consultations.
- Test of algorithms for detecting an increase in weight on two days following clinical cardiac guidelines (Ponikowski et al 2016).
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
- None
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
- •Patients diagnosed with HF NYHA Class II-IV, who have a current hospitalization for acute decompensated HF or a visit to the HF outpatient clinic within the past two weeks
- •Patients with an EF of 40% or less
- •Adults (18 years or older); no upper age limit
- •Patients living in Viborg and Skive Municipality
- •Patients living at home and capable of caring for themselves
- •Have basic computer skills or a relative who have basic computer skills
排除标准
- •Pregnancy
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •Present and previous neurologic, musculoskeletal or cognitive disability or active psychiatric history (as noted in the medical record) other than depression or anxiety related to cardiac or other chronic illness
- •Lack of ability to cooperate
- •Does not speak/read/understand Danish
结局指标
主要结局
Health-related quality of life
时间窗: Intervention: at baseline, after 1 month, after 2 months, after 3 months, after 4 months, after 5 months, after 6 months. Control: baseline, after 3 months, after 6 months
15 % increase in health-related quality of life measured by HeartQoL
次要结局
- Testing an algorithm on weight based on adherence(Intervention group: at baseline, week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26)
- Number of readmissions(For both intervention and control group: 6 months)
- Degree of depression(For both intervention and control group: at baseline, 3 months, and 6 months)
- Experiences of HF patients and healthcare professionals with the use of video consultations(Intervention group: at month 6)
- Reduction of the number of visits to the outpatient clinic(For both intervention and control group: 6 months)
- Number of tele-communicational (phone and video) contacts(For both intervention and control group: 6 months)
- Use of the website "Hjerteportalen.dk"(Intervention group: 6 months)
研究者
Birthe Dinesen
Professor, PhD, Master in Political Science, RN, Head of Laboratory of Welfare Technology - Telehealth & Telerehabilitation
Aalborg University