Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06306235
Other study ID # 20.84-reva20.06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 12, 2020
Est. completion date July 31, 2021

Study information

Verified date October 2022
Source Jessa Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients who are eligible for cardiac rehabilitation but do not want to participate will be offered to participate in an interview (part A of the study) or a tablet questionnaire (part B of the study). Goal is to identify main barriers for conventional rehabilitation as well as to assess willingness to participate in cardiac telerehabilitation, main barriers and willingness-to-pay for cardiac telerehabilitation.


Description:

Cardiac rehabilitation (CR) is indicated in patients with a wide range of cardiovascular diseases. Its benefits are well-studied and participation in CR is thus stated as a Class IA recommendation in the 2016 European Guidelines on cardiovascular disease prevention in clinical practice. It is known however that participation rates are low. This is due to multiple factors such as health system barriers (e.g. lack of referral by doctors), as well as patient factors (eg. travelling time to hospital). Telerehabilitation is a modality of cardiac rehabilitation that is widely studied to overcome barriers in conventional cardiac rehabilitation. Most studies about telerehabilitation screen for potential rehabilitation candidates, ask which patients are prepared to start centre-based rehabilitation and then start randomisation for centre-based or home-based rehabilitation. The hypothesis is that by offering a home-based alternative for centre-based rehabilitation, patient participation rates will go up. However, this hypothesis has not been investigated. The willingness to participate in patients that refuse centre-based rehabilitation is thus scarcely studied. This study aims to assess the willingness to participate in telerehabilitation in patients that refuse conventional centre-based rehabilitation as well as the main reasons not to participate in centre-based rehabilitation. Methods Patients that are eligible for participating in cardiac rehabilitation will be offered to do so as usual. Those who do not wish to participate or are not sure whether they will participate in cardiac rehabilitation will be asked to participate in this study. The first part of this study is a pilot part in which 30 patients will be included. These patients will be interviewed by one of the researchers (dr. Maarten Falter or dr. Martijn Scherrenberg). A semi-structured interview of 20 minutes will be performed to assess the most important barriers for rehabilitation, willingness-to-pay and possible barriers for telerehabilitation, as well as patient profile and socio-economic background. Informed consent will also be asked to collect patient data from the hospital records (age, gender, cardiac disease, cardiac index event, cardiac device implanted, indication for rehabilitation, date of primary cardiac event, length of hospital stay, cardiac rehabilitation history, procedures performed, comorbidities, distance from home to hospital, Mobiscore, smoking status, length, weight, medication, ejection fraction) as these factors are possible determinants of the outcome of our study. The second part of this study is a survey that will assess the most important barriers in 300 patients. This survey will be constructed using the main barriers found in literature in combination with main barriers mentioned by the pilot population. The survey will consist of multiple-choice questions and will again assess main barriers for participating in rehabilitation and telerehabilitation. The survey will be completed using an iPad from the cardiology department using Qualtrics while the patient is still in the hospital. The Qualtrics license is obtained via Hasselt University. Informed consent will also be asked to collect patient data from the hospital records (see variables above). All study results will be stored on a secured drive of Jessa hospital (K-drive). Only the health professionals with a therapeutic relation, the principal investigator and the local investigator can access this list. Data will be converted into a pseudonymized database for further statistical analysis in collaboration with the University of Hasselt or for analysis in collaboration with bachelor students of the University of Hasselt. Patients will only be included in the Jessa hospital.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Eligible for conventional cardiac rehabilitation - Not willing to participate in conventional cardiac rehabilitation. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
Part A: 30 patients will be interviewed. Part B: 300 patients will complete written questionnaire on tablet.

Locations

Country Name City State
Belgium Jessa Hospital Hasselt Limburg

Sponsors (1)

Lead Sponsor Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Willingness to participate in telerehabilitation Is the patient willing to participate in telerehabilitation? Based on question asked in interview, response will be recorded and evaluated by two independent investigators. Immediate assessment of willingness during patient interview.
See also
  Status Clinical Trial Phase
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05773287 - Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation N/A
Completed NCT05551429 - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Completed NCT02542163 - Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR) N/A
Not yet recruiting NCT05989594 - Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing TAVR N/A
Active, not recruiting NCT05026957 - A Digitally-Supported Shared Decision Making Approach for Coronary Artery Disease Patients During Cardiac Rehabilitation N/A
Recruiting NCT03734185 - Cardiac Rehabilitation: From Hospital to Municipal Setting. N/A
Recruiting NCT05826587 - Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention N/A
Completed NCT03174106 - Longterm Follow-up of Cardiac Patients With an Smartphone-Application N/A
Recruiting NCT05725655 - Hot Water Immersion After Myocardial Infarction N/A
Not yet recruiting NCT05019157 - Cardiac Telerehabilitation Effectiveness Using Wearable Sensors N/A
Recruiting NCT06025526 - Effectiveness of the Aktivplan Digital Intervention (ACTIVE-CaRe Pilot) N/A
Recruiting NCT05099692 - CHD Patient's Concern on Cardiac Rehabilitation
Recruiting NCT06039969 - Evaluate Aerobic Exercise on Myocardial Fibrosis and Intestinal Flora in Dilated Cardiomyopathy Diagnosed First Time.
Not yet recruiting NCT06065319 - Wearables and Cardiac Rehabilitation
Recruiting NCT06127537 - Study on the Efficacy of HE and Therapeutic Group Factors on CR and QoL N/A
Completed NCT04738383 - Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation N/A
Active, not recruiting NCT03922529 - Modified Application of Cardiac Rehabilitation for Older Adults N/A
Completed NCT00956657 - Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial N/A
Completed NCT03991715 - Sustaining Physical Activity Following Cardiac Rehabilitation Completion N/A