Ignite Creation Date:
2024-05-06 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05207072
Status:
UNKNOWN
Last Update Posted:
2022-01-26
First Post:
2021-12-24
Brief Title:
Mobile Tele-Monitoring Guided Cardiac Rehabilitation in Post-Acute Coronary Syndrome Patients
Sponsor:
Maastricht University
Organization:
Maastricht University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REHAB
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 ie 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
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 ie 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 patients 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 05 Assuming 80 power and 5 two-sided significance level alpha005 the sample size n required to achieve a probability of 80 of detecting a difference in the QoL level between two groups is n268 per group
Based on 10 withdrawal or incomplete data the investigators aim for a group size of n 300 per group n600 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 12 Therefore a total of 900 patients will be included in the study
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 patients 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 05 Assuming 80 power and 5 two-sided significance level alpha005 the sample size n required to achieve a probability of 80 of detecting a difference in the QoL level between two groups is n268 per group
Based on 10 withdrawal or incomplete data the investigators aim for a group size of n 300 per group n600 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 12 Therefore a total of 900 patients will be included in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 210707 | OTHER_GRANT | The European Institute of Innovation and Technology | None |