Long-term Effects of Individualized Follow-up With an App for One Year
September 8, 2023 updated by: Oslo Metropolitan University
Effect of Using a Smartphone Application to Promote Adherence to Healthy Behaviour Post-cardiac Rehabilitation: Five Year Follow-up of a Randomized Controlled Trial
The aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-CR.
Study Overview
Status
Completed
Conditions
Detailed Description
Recently, our research group demonstrated that individualized follow-up with an app for one year post-Cardiac Rehabilitation (post-CR) significantly improved exercise capacity, exercise habits and self-perceived goal achievement compared to a control group receiving usual care.
To prepare for real-world implementation of an app to promote healthy behaviour post-CR, we will investigate the long-term effects (3-5 year post intervention).
The aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-CR.
We hypothesize that patients allocated to the intervention group post-CR have internalized healthy behaviour and therefore have significantly higher exercise capacity and lower bodyweight compared to the control group, 3-5year post intervention.
Study Type
Observational
Enrollment (Actual)
102
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway
- Oslo Metropolitan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
41 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients participating in cardiac rehabilitation.
The sample in this study will be the same as in the RCT of which this study is built on (ClinicalTrials.gov
NCT03174106)
Description
Inclusion Criteria:
- Included in the RCT of which this study is built on
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak oxygen uptake
Time Frame: 5 year post rehab
|
Relative VO2peak (ml/kg/min)
|
5 year post rehab
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to exhaustion
Time Frame: 5 year post rehab
|
Time on treadmill measured in seconds
|
5 year post rehab
|
|
Peak incline
Time Frame: 5 year post rehab
|
Incline (%) at treadmill in the end of the test
|
5 year post rehab
|
|
Peak velocity
Time Frame: 5 year post rehab
|
Kilometer per hour in the end of the test
|
5 year post rehab
|
|
Bodyweight
Time Frame: 5 year post rehab
|
Kilograms
|
5 year post rehab
|
|
Exercise habits
Time Frame: 5 year post rehab
|
Mean number of exercise sessions each week for the last year
|
5 year post rehab
|
|
Health related quality of life
Time Frame: 5 year post rehab
|
HeartQoL
|
5 year post rehab
|
|
Health status
Time Frame: 5 year post rehab
|
EQ5D
|
5 year post rehab
|
|
Cardiovascular events
Time Frame: 5 year post rehab
|
Number of new cardiovascular events in the last five years
|
5 year post rehab
|
|
Dietary habits
Time Frame: 5 year post rehab
|
"Hva spiser du" - a norwegian questionnaire developed to assess nutrional habits
|
5 year post rehab
|
|
LDL cholesterol
Time Frame: 5 year post rehab
|
Blood sample
|
5 year post rehab
|
|
HDL cholesterol
Time Frame: 5 year post rehab
|
Blood sample
|
5 year post rehab
|
|
Total cholesterol
Time Frame: 5 year post rehab
|
Blood sample
|
5 year post rehab
|
|
Triglycerides
Time Frame: 5 year post rehab
|
Bloodsample
|
5 year post rehab
|
|
Physical activity
Time Frame: 5 year post rehab
|
IPAQ
|
5 year post rehab
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2023
Primary Completion (Actual)
September 7, 2023
Study Completion (Actual)
September 7, 2023
Study Registration Dates
First Submitted
November 3, 2022
First Submitted That Met QC Criteria
January 16, 2023
First Posted (Actual)
January 25, 2023
Study Record Updates
Last Update Posted (Actual)
September 11, 2023
Last Update Submitted That Met QC Criteria
September 8, 2023
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OsloMetU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.