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

NCT05207072 | Unknown

• 2 other identifiers: Z20210177210707
• Study Type: observational
• Target: 900
• Locations: 2 countries
• Sites: 4

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.

Conditions

Cardiac Rehabilitation; Acute Coronary Syndrome

Keywords

Cardiac Telerehabilitation; Acute Coronary Syndrome; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life measured by the SF-36 questionnaire.

  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).

  At 12 months (T2) and baseline (T0)

Secondary Outcomes (8)

• 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)

• Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ).

  At 12 months (T2), 3 months (T1) and baseline (T0)

• Self-reported impact of eHealth on its users measured by the e-Health Impact Questionnaire (eHIQ).

  At 3 months (T1)

• Change in metabolic equivalent of task (MET) as calculated from treadmill or cycle ergometry.

  At 12 months (T2) and baseline (T0)

Study Arms (2)

Mobile Cardiac Rehabilitation (mCR) group

The mCR programme involves a home-based programme for 12 months in which patients are supplied with a smartphone/application with a data subscription from LIVA. Through this application patients are able to measure and register physical activity, heart frequency and intensity (BORG scale) and can monitor progress. A healthcare professional (coach) also has access to a portal to monitor progress of different patients, advice on rehabilitation approach and stimulate compliance. Together with their coaches every patient makes their own rehabilitation programme. Patients will be coached for 12 months starting intensively with decreasing amounts of contacts over time.

Traditional Cardiac Rehabilitation (CR) group

The traditional CR programme involves standard a standard CR programme over a 6-8 weeks period. Subjects receive no advice or coaching after the end of the traditional CR program.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects of 18 years or older following acute myocardial infarction.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Insufficient knowledge of the native language;
• Participating in CR elsewhere.

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (4)

Stichting Zuyderland Medisch Centrum

Heerlen, Limburg, 6419PC, Netherlands

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, Spain

NOT YET RECRUITING

Hospital Virgen de la Victoria de Málaga

Málaga, Spain

NOT YET RECRUITING

Related Publications (1)

• van Mierlo RFR, Houben VJG, Rikken SAOF, Gomez-Doblas JJ, Lozano-Torres J, van 't Hof AWJ. Cardiac (tele)rehabilitation in routine clinical practice for patients with coronary artery disease: protocol of the REHAB + trial. Front Cardiovasc Med. 2024 Jul 29;11:1387148. doi: 10.3389/fcvm.2024.1387148. eCollection 2024.

  PMID: 39224752 DERIVED

Related Links

• Links to the REHAB+ project on the website of the grant funding organization (European Institute of Innovation and Technology).

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Arnoud van 't Hof, MD PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vital Houben, MD

CONTACT

088 - 459 9718; v.houben@zuyderland.nl

Sem Rikken, MD

CONTACT

088 - 459 9718; a.rikken@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology, MD PhD

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 26, 2022
• Study Start: December 6, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); ES (3)