Future Patient - Telerehabilitation of Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Increased quality of life
研究概览
简要总结
The idea behind the Future Patient research project is to develop a telerehabilitation program and tools for patients with heart failure.
The hypothesis for this study is that participation in a telerehabilitation program for patients with heart failure will increase the patients' quality of life and multi-parametric (subjective and objective) individualized monitoring in a telerehabilitation program for patients with heart failure will increase detection of worsening of symptoms and avoid future hospitalization of the HF-patients.
详细描述
The overall aim is to test, implement and evaluate a telerehabilitation program for patients with heart failure from clinical, psychosocial, health literacy and e-health literacy, inter-organizational, health economic and technical perspectives.
Furthermore, this study has sub aims:
- To increase the quality of life for patients with Heart Failure (HF)
- To optimize the medical treatment of patients with HF
- To perform multi-parametric (subjective and objective) individualized monitoring in order to detect worsening of symptoms and avoid hospitalizations
- To increase physical activities for patients with heart failure in everyday life in a telerehabilitation program
- To facilitate patient-initiated self-care management actions upon the following early detection of changes in source data (steps taken, weight, blood pressure, pulse, sleep, illness perception, motivation, anxiety and depression)
- To evaluate patients health literacy and e-health literacy participating in a telerehabilitation program and rehabilitation program
- To test and evaluate the Heart Portal - a digital toolbox for improved self-management for patients with heart failure and their relatives
- To explore the experiences and perspectives of the patients and their relatives when being part of a telerehabilitation program
- To test and evaluate a cross sector communication platform from a patient and healthcare professional perspective
- To perform a cost-effectiveness analysis of total costs of healthcare and rehabilitation services
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 according to New York Heart Association (NYHA) Class I-IV with max 20 % in class I or who have a current hospitalization for acute decompensated HF within the past two weeks
- •Adults (18 years or older); no upper age limit
- •Patients living in Viborg and Skive Municipality
- •Living at home and capable of caring for him/herself
- •Have basic computer skills or a relative who have basic computer skills
- •Informed consent to participate in a telerehabilitation program
- •May have a pacemaker
排除标准
- •Pregnancy
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •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 Danish
结局指标
主要结局
Increased quality of life
时间窗: Intervention group: At baseline, week 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32, 34,36,38,40,42,44,46,48,50,52 Control group: Baseline, 6 & 12 months
Increased quality of life as measured by a moderate change (10 points) in quality of life measured by Kansas City Questionnaire (KCCQ)
次要结局
- Steps taken(Intervention group: Everyday for 12 months)
- Development of pulse(Intervention group: Pulse from date of randomization and every day in 12 months)
- Development of weight(Intervention group: Weight from date of randomization and every day in 12 months)
- All cause hospitalization(For both intervention and control group: 6 months)
- Development of bloodpressure(Intervention group: Blood pressure (mmHG) from date of randomization twice a week assessed up to 3 months)
- Sleep(Intervention group: Sleep from date of randomization and accessed up to 12 months)
- Anxiety and depression(For both intervention and control group: At baseline, 6 & 12 months)
- eHealth literacy(For both intervention and control group: At baseline, 6 & 12 months)
- Experiences of using the Heart portal(For intervention group: 6 & 12 months)
- Costs of healthcare and rehabilitation services(For both intervention and control group: 6 months)
- Time from baseline to optimized medical treatment(For both intervention and control group: From date of randomization until the date of first documented progression with medical treatment, assessed up to 4 months)
- Illness perception(For Intervention and control group: At baseline, 6 & 12 months)
- Motivation(For both intervention and control group: At baseline, 6 & 12 months)
- Health- literacy(For both intervention and control group: At baseline)
研究者
Birthe Dinesen
Professor
Aalborg University