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

Acute Coronary Syndrome Clinical Trial

— REHAB+  

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+)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05207072
• Other study ID #: Z20210177
• Secondary ID: 210707
• Status: Recruiting
• Start date: December 6, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2022
• Source: Maastricht University
• Contact: Vital Houben, MD
• Phone: 088 - 459 9718
• Email: v.houben[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiac Rehabilitation
• Syndrome

Locations

Country	Name	City	State
Netherlands	Stichting Zuyderland Medisch Centrum	Heerlen	Limburg
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Virgen de la Victoria de Málaga	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Countries where clinical trial is conducted

Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 3 months (T1) 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 3 months (T1) and baseline (T0)
Secondary	Rate of re-hospitalization or visits to the emergency department.	The occurrence of re-hospitalizations or visits to the emergency department between baseline and the end of follow-up.	At 12 months (T2)
Secondary	Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ).	The IPAQ short form (IPAQ-sf) with an activity diary (in minutes/week) will be used to evaluate the physical activity level of the participants. Results will be reported in categories (low activity levels, moderate activity levels or high activity levels).	At 12 months (T2), 3 months (T1) and baseline (T0)
Secondary	Self-reported impact of eHealth on its users measured by the e-Health Impact Questionnaire (eHIQ).	The eHealth Impact Questionnaire (eHIQ) measures users' attitudes towards an application which they recently viewed. It is divided into the 11-item eHIQ-Part 1, asking for general attitudes towards using the internet to access health information and the 26-item eHIQ-Part 2, which is related to the effects of using a specific health-related application on three subscales: 1) confidence and identification, 2) information and presentation and 3) understanding and motivation. Both answering formats range from 1 (strongly disagree) to 5 (strongly agree). Part 1 will be assessed in both groups, while part 2 will only be assessed in the mCR group.	At 3 months (T1)
Secondary	Change in metabolic equivalent of task (MET) as calculated from treadmill or cycle ergometry.	Physical fitness level will be measured as number of MET during an incremental maximal exercise test (cycling or treadmill). The test will be performed under supervision. All tests will be performed by the same protocol. For patients who are not able to participate cycling test, this test will be replaced by the treadmill Test. The testing modality chosen per centre at T0, will remain the same at T2. To ensure a safe environment in which the tests can be performed, the test will be performed to applicable guidelines and regulations within each participating centre.	At 12 months (T2) and baseline (T0)
Secondary	Change in lipid profile	Blood samples as part of standard care will be obtained to assess changes in lipid profiles (in mmol/L).	At 12 months (T2), at 3 months (T1) and at baseline (T0)
Secondary	Change in HbA1c	Blood samples as part of standard care will be obtained to assess changes in HbA1c (in mmol/mol).	At 12 months (T2), at 3 months (T1) and at baseline (T0)
Secondary	Change in smoking (tobacco addiction) according to the Fagerström test.	The Fagerström test consists of six questions. The minimum value is 0 points and maximum values is 10 points. The higher score represents the greater nicotine dependence.	At 12 months (T2), at 3 months (T1) and at baseline (T0)

External Links

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