Clinical trial NCT05207072: Mobile Tele-Monitoring Guided Cardiac Rehabilitation in Post-Acute Coronary Syndrome Patients
Official title: Prospective Observational Trial for a Cardiac Rehabilitation eHealth Application in Post-ACS Patients; Assessment of the Effects on Sustainability and Participation Level (REHAB+)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Rehabilitation
Acute Coronary Syndrome
Keywords: Cardiac Telerehabilitation
Acute Coronary Syndrome
Cardiac Rehabilitation
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of 18 years or older following acute myocardial infarction.

Brief summary: 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.

Detailed description: 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.

Based on 10% withdrawal or incomplete data, the investigators aim for a group size of n= 300 per group (n=600 in total). In order to find a control group of 300 matched patients, 600 consecutive patients following regular CR will be registered. The investigators expect patients choosing for mCR versus regular CR in a ratio of 1:2. Therefore a total of 900 patients will be included in the study.

Eligibility criteria: During admission after myocardial infarction all eligible patients for CR will be informed about the study and requested to participate.

Inclusion Criteria

Subjects of 18 years or older who are a candidate for CR with the following criteria:

* Patients with a myocardial infarction (both STEMI and NSTEMI);
* Signed written informed consent.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Contraindication to CR;
* Mental impairment leading to inability to cooperate;
* Severe impaired ability to exercise;
* participating in a cardiac rehabilitation programme at the time of inclusion;
* Insufficient knowledge of the native language;
* Participating in CR elsewhere.

Primary outcomes:
measure: Change in Quality of Life measured by the SF-36 questionnaire.
timeFrame: At 12 months (T2) and baseline (T0)
Secondary outcomes:
measure: Change in Quality of Life measured by the SF-36 questionnaire.
timeFrame: At 3 months (T1) and baseline (T0)
measure: Rate of re-hospitalization or visits to the emergency department.
timeFrame: At 12 months (T2)
measure: Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ).
timeFrame: At 12 months (T2), 3 months (T1) and baseline (T0)
measure: Self-reported impact of eHealth on its users measured by the e-Health Impact Questionnaire (eHIQ).
timeFrame: At 3 months (T1)
measure: Change in metabolic equivalent of task (MET) as calculated from treadmill or cycle ergometry.
timeFrame: At 12 months (T2) and baseline (T0)
measure: Change in lipid profile
timeFrame: At 12 months (T2), at 3 months (T1) and at baseline (T0)
measure: Change in HbA1c
timeFrame: At 12 months (T2), at 3 months (T1) and at baseline (T0)
measure: Change in smoking (tobacco addiction) according to the Fagerström test.
timeFrame: At 12 months (T2), at 3 months (T1) and at baseline (T0)
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Stichting Zuyderland Medisch Centrum
state: Limburg
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria de Málaga
Study officials:
affiliation: Maastricht University
name: Arnoud van 't Hof, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: