HeartHab: a Prospective Cross-over Trial Investigating the Effectiveness of an App Based Telerehabilitation Program on Exercise Capacity, Lifestyle and Risk Factors in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in VO2peak
研究概览
简要总结
The recurrence of major cardiac events after infarction is very high, in some populations up to 20% in the first year. Optimal secondary prevention as organized in cardiac rehabilitation centers is effective in reducing both morbidity and mortality. However, many studies have shown that the participation and adherence rate in CR-programs is low in most European countries. Therefore, novel ways of delivering secondary prevention using information technology and self-monitoring are being explored. Hence, this study will investigate the effectiveness of a mobile, patient tailored, app based multidisciplinary telerehabilitation program (HeartHab app) in improving exercise capacity, lifestyle and risk factors in patients with coronary artery disease in a post-rehabilitation setting.
详细描述
Study design and population This study is a prospective double-arm, non-pragmatic, cross-over, randomized controlled trial. Approximately 30 subjects will be selected retrospectively from the cardiology database of the Jessa Hospital Hasselt. Subjects who do not violate any of the predefined exclusion criteria and have provided informed consent will be randomly assigned in a 1:1 ratio to the treatment strategies (AB sequence or BA sequence).
After two months, each individual will be switched to the other treatment strategy.
Measurements At baseline, after two months (+14 days) and after four months (+14 days), a clinical assessment, medical history, current medication therapy, fasting blood sample, maximal cardiopulmonary exercise test, pulmonary function and three completed questionnaires (HeartQol, IPAQ and EQ-5D) will be collected of all patients. A fourth questionnaire will be completed by all the patients, focusing on the usability of the HeartHab-application.
Statistical analysis Data analysis will be performed using SPSS version 22 (SPSS Inc, Chicago, IL, USA) according to the intention-to-treat principle by assigned treatment group. Nonparametric alternatives will be used for parametric statistics in case assumptions for the latter are violated. The Shapiro-Wilk test will be used to assess normality. Paired t tests (parametric) or Wilcoxon signed rank tests (nonparametric) will be used for within-group analysis; independent t tests (parametric) or Mann-Whitney U tests (nonparametric) for between-group analysis. Chi-square tests will be used in case of categorical variables; Fisher's exact tests will be used when expected frequencies are small. The significance level for tests is 2-sided α=.05.
The cost-effectiveness evaluation will be conducted from a society and patient perspective, taking into account both intervention and health care resource costs. As the majority of patients will be retired, productivity losses due to illness-related absence from the workplace will not be taken into account.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •History of coronary artery disease with or without intervention (PCI/CABG/conservative)
- •History of a cardiac rehabilitation (CR) program
- •Clinically stable without inducible ischemia or high risk ventricular arrhythmia, confirmed by the last available maximal ergospirometry test
- •Age ≥18 years
- •Willing and physically able to follow an app based telerehabilitation program and other study procedures in a four months follow-up period
- •Evidence of a personally signed and dated informed consent, indicating that the subject (or legally-recognised representative) has been informed of all pertinent aspects of the study
- •Possession of and/or able to use an Android smartphone
- •Dutch speaking and understanding
排除标准
- •Recent PCI or CABG procedure, and still included in a CR program
- •Orthopedic, neurologic or any other pathologic condition which makes the patient physically unable to follow an app based telerehabilitation program
- •Planned interventional procedure or surgery in the next four months
- •Pregnant females
- •Present cardiovascular complaints
- •Participation in other cardiac rehabilitation program trials, focusing on exercise outcome
- •Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than 4 months based on investigators judgement
研究组 & 干预措施
AB sequence
Usual care followed by use of HeartHab application: Treatment A comprises the usual care (i.e. one information session on the importance of medication adherence, risk factor control and healthy lifestyle), followed by telemonitoring during treatment B. The tele-intervention will consist of two months telerehabilitation and telecoaching concerning physical activity, healthy lifestyle and medication adherence.
干预措施: Usual care followed by the use of HeartHab application (Other)
BA sequence
Use of HeartHab application followed by usual care: patients will be followed by telemonitoring during treatment B. The tele-intervention will consist of two months telerehabilitation and telecoaching concerning physical activity, healthy lifestyle and medication adherence, followed by treatment A comprises the usual care (i.e. one information session on the importance of medication adherence, risk factor control and healthy lifestyle)
干预措施: Use of HeartHab application followed by usual care (Other)
结局指标
主要结局
Change in VO2peak
时间窗: month 4 + 14 days
Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)
Change in VO2peak
时间窗: day1
Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)
Change in VO2peak
时间窗: month 2 + 14 days
Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)
次要结局
- Risk factor profile: physiological parameter(month 4 + 14 days)
- Exercise capacity: questionnaire(month 4 + 14 days)
- Quality of life: questionnaire(month 4 + 14 days)
- Generic health status: questionnaire(month 4 + 14 days)
- Cardiovascular events: clinical assessment(month 4 + 14 days)
- Generic health status: questionnaire(day 1)
- Risk factor profile: physiological parameter(day 1)
- Generic health status: questionnaire(month 2 + 14 days)
- Risk factor profile: physiological parameter(month 2 + 14 days)
- Exercise capacity: questionnaire(month 2 + 14 days)
- Exercise capacity: questionnaire(day 1)
- Quality of life: questionnaire(day 1)
- Quality of life: questionnaire(month 2 + 14 days)
- Cardiovascular events: clinical assessment(day 1)
- Cardiovascular events: clinical assessment(month 2 + 14 days)
研究者
prof. dr. Paul Dendale
Principal Investigator
Hasselt University