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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06813482




Registration number
NCT06813482
Ethics application status
Date submitted
22/01/2025
Date registered
7/02/2025

Titles & IDs
Public title
Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program
Scientific title
Heart Health at Home - Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program
Secondary ID [1] 0 0
321/21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Disease 0 0
Chronic Disease 0 0
Cardiovascular Disease Prevention 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
BEHAVIORAL - Digitally enabled cardiac rehabilitation
BEHAVIORAL - F2F-CR
BEHAVIORAL - Usual Care Group

DeCR - Heart Health at Home - Digitally enabled cardiac rehabilitation

F2F-CR - Traditional Face-to-Face Cardiac Rehabilitation

Usual Care - Usual Care - eligible for cardiac rehabilitation and who unlikely participated in any formal cardiac rehabilitation program


BEHAVIORAL: Digitally enabled cardiac rehabilitation
The intervention consists of an 8-week remotely delivered cardiac rehabilitation program. It includes an initial assessment during week 1, six weeks of participation in a digitally enabled cardiac rehabilitation (DeCR) program (weeks 2-7), and a final assessment in week 8. Participants will utilize a digital mobile application and receive weekly telehealth consultations with a cardiac nurse. The program is designed to facilitate behavior change and improve outcomes through the following modalities:

1. Telehealth - individualized coaching delivered via telephone by a cardiac nurse, to ensure that patient's take their medications as prescribed and to give health education and guidance on lifestyle changes.
2. Mobile application (called SmartCR) and nurse web portal - for remote monitoring and personalized care planning. The app monitors health and physical activity, has prompted tasks and delivers education via video, audio and written articles.

BEHAVIORAL: F2F-CR
Traditional Face-to-face cardiac rehabilitation

BEHAVIORAL: Usual Care Group
Usual Care - eligible for cardiac rehabilitation and who unlikely participated in any formal cardiac rehabilitation program
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hospital utilization
Timepoint [1] 0 0
30-day, 90-day and 12-month post discharge
Primary outcome [2] 0 0
Hospital utilization
Timepoint [2] 0 0
30-day, 90-day and 12-month post discharge
Primary outcome [3] 0 0
Mortality
Timepoint [3] 0 0
30-days and 12-month post discharge
Secondary outcome [1] 0 0
Blood pressure
Timepoint [1] 0 0
At completion of the intervention at 8 weeks.
Secondary outcome [2] 0 0
Body mass index
Timepoint [2] 0 0
At completion of the intervention at 8 weeks.
Secondary outcome [3] 0 0
Diet
Timepoint [3] 0 0
At completion of the intervention at 8 weeks
Secondary outcome [4] 0 0
Alcohol intake - average number of standard alcoholic drinks consumed per week
Timepoint [4] 0 0
At completion of the intervention at 8 weeks
Secondary outcome [5] 0 0
Physical activity
Timepoint [5] 0 0
At completion of the intervention at 8 weeks
Secondary outcome [6] 0 0
Patient Activation Measure
Timepoint [6] 0 0
At completion of the intervention at 8 weeks
Secondary outcome [7] 0 0
Functional capacity - Duke Activity Status Index
Timepoint [7] 0 0
At completion of the intervention at 8 weeks
Secondary outcome [8] 0 0
Kessler Psychological Distress Scale
Timepoint [8] 0 0
At completion of the intervention at 8 weeks.
Secondary outcome [9] 0 0
Quality of life - EuroQol-5 Dimension questionnaire
Timepoint [9] 0 0
At completion of the intervention at 8 weeks.
Secondary outcome [10] 0 0
Medication adherence - 4-item Morisky Medication Adherence Scale
Timepoint [10] 0 0
At completion of the intervention at 8 weeks.

Eligibility
Key inclusion criteria
1. Patients aged over 18 years AND
2. hold private health insurance with Medibank at a level that includes cover for hospital treatment AND
3. Discharged from hospital with a cardiovascular diagnosis and/or procedure eligible for cardiac rehabilitation, as defined by the National Heart Foundation of Australia AND
4. be able to give written consent to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with heart failure; OR
2. Patients attending an alternate cardiac rehab program for the corresponding index event; OR
3. Patients who do not have access to a smart phone and internet connection

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2022
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Medibank
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Melinda J Carrington
Address 0 0
Baker Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification and underlying published results, the data underlying the study may be shared on reasonable request to the Principal Investigator and approval by the Contributors. The deidentified data may only be available to researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Principal Investigator and study Contributors.
When will data be available (start and end dates)?
Following publication; no end date
Available to whom?
Access subject to approvals by Principal Investigator and study Contributors
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://baker.edu.au/research/laboratories/preclinical-disease-prevention


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06813482