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Mobile Tele-Monitoring Guided Cardiac Rehabilitation in Post-Acute Coronary Syndrome Patients

NCT05207072 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2022-01-26

No results posted yet for this study

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.

Conditions

  • Cardiac Rehabilitation
  • Acute Coronary Syndrome

Sponsors & Collaborators

  • Maastricht University

    lead OTHER

Principal Investigators

  • Arnoud van 't Hof, MD PhD · Maastricht University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2023-09-01
Completion
2023-12-01

Countries

  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05207072 on ClinicalTrials.gov