Prospective Observational Trial for a Cardiac Rehabilitation eHealth Application in Post-ACS Patients; Assessment of the Effects on Sustainability and Participation Level (REHAB+)
试验速览
- 阶段
- 不适用
- 入组人数
- 900
- 试验地点
- 4
- 主要终点
- Change in Quality of Life measured by the SF-36 questionnaire.
研究概览
简要总结
Cardiac rehabilitation (CR) programmes are effective measures to reduce recurrent ischemic events in post-acute coronary syndrome (ACS) patients. However, participation rates in CR programmes following myocardial infarction remain low and their long-term effects are uncertain.
Home-based CR in combination with novel innovative e-Health applications could overcome barriers to accessibility and participation. Rehab+, a mobile cardiac rehabilitation (mCR) programme co-created with patients and rehabilitation centres, is designed to future-proof CR and to make CR more accessible to patients. Moreover, Rehab+ will be offered for 12 consecutive months after myocardial infarction and could therefore result in greater sustained effects.
This prospective, investigator-initiated, multicentre, matched control, observational trial intends to enroll 900 post-ACS patients. Subjects following ACS will be enrolled in the hospital if they meet all the eligibility criteria. Each subject will be able to choose between one of the 2 treatment groups, i.e. 12 months of mCR or 6-8 weeks of traditional centre-based CR. The follow-up for each subject will take 12 months for both groups.
The primary objective of this study is to assess whether mCR programme result in better sustained effects on physical, mental and social outcomes in post-ACS patients, as compared to post-ACS patients who follow the traditional CR programme.
The main hypothesis is that mCR is expected to result in greater improvement in Quality of Life at 12 months as compared to traditional CR.
详细描述
Subjects will be screened during hospitalisation following myocardial infarction. All eligible patients for CR will be informed about the study and requested to participate. Those fulfilling the eligibility criteria who have provided written informed consent will be allocated based upon patient preference to the mCR group with mobile tele-monitoring guidance or the control group following the regular CR programme.
Patient data will be collected at three different time points, T0 at inclusion (baseline), T1 after 3 months and T2 after 12 months. Data will be administered from the patient's (electronic) health record collected during usual care. Extra data will be administered through questionnaires.
Patients can leave the study at any time for any reason if they wish to do so without any consequences. The site investigator can decide to withdraw a patient from the study for urgent medical reasons.
In order to assess the effects on sustained physical fitness after participation in the mCR programme it was determined that an inclusion of 300 patients per group would be sufficient to examine the aim of this study.
This is based on the expected difference in increase in Quality of Life at 12 months between the mCR and matched traditional CR group with an estimated standard deviation of 7 units (Physical component score SF-36 questionnaire) in both groups. The base correlation is expected to be 0.5. Assuming 80% power and 5% two-sided significance level (alpha=0.05), the sample size (n) required to achieve a probability of 80% of detecting a difference in the QoL level between two groups, is n=268 per group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Quality of Life measured by the SF-36 questionnaire.
时间窗: At 12 months (T2) and baseline (T0)
Short Form 36 (SF-36) quality of life scale will be used to evaluate health-related quality of life between the end of follow-up (T2) and baseline (T0). Items are grouped in 8 scaled scores exploring multiple dimensions of health (vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health). Scoring will be performed as recommended by the SF-36 instruction manual to create the eight scale scores. Furthermore, these subscales sum to obtain the total SF-36 score and will be summarized into two composite scores (physical and mental quality of life).
次要结局
- Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ).(At 12 months (T2), 3 months (T1) and baseline (T0))
- Change in Quality of Life measured by the SF-36 questionnaire.(At 3 months (T1) and baseline (T0))
- Rate of re-hospitalization or visits to the emergency department.(At 12 months (T2))
- Self-reported impact of eHealth on its users measured by the e-Health Impact Questionnaire (eHIQ).(At 3 months (T1))
- Change in HbA1c(At 12 months (T2), at 3 months (T1) and at baseline (T0))
- Change in metabolic equivalent of task (MET) as calculated from treadmill or cycle ergometry.(At 12 months (T2) and baseline (T0))
- Change in lipid profile(At 12 months (T2), at 3 months (T1) and at baseline (T0))
- Change in smoking (tobacco addiction) according to the Fagerström test.(At 12 months (T2), at 3 months (T1) and at baseline (T0))
研究者
AWJ van t Hof
Professor of Cardiology, MD PhD
Maastricht University