Coronary Artery DiseaseNCT05697120
Long-term Effects of Individualized Follow-up With an App for One Year
An observational study of Coronary Artery Disease, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 102 participants
- Where
- 1 siteNorway
- Study dates
- 7 Feb 2023to 7 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Included in the RCT of which this study is built on
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac rehabilitation, mHealth, mobile phone app, Lifestyle, Smartphone
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
Relative VO2peak (ml/kg/min)
Measured: 5 year post rehab
Secondary outcomes (14)
Time to exhaustion
Time on treadmill measured in seconds
Measured: 5 year post rehab
Peak incline
Incline (%) at treadmill in the end of the test
Measured: 5 year post rehab
Peak velocity
Kilometer per hour in the end of the test
Measured: 5 year post rehab
Bodyweight
Kilograms
Measured: 5 year post rehab
LDL cholesterol
Blood sample
Measured: 5 year post rehab
HDL cholesterol
Blood sample
Measured: 5 year post rehab
Total cholesterol
Blood sample
Measured: 5 year post rehab
Exercise habits
Mean number of exercise sessions each week for the last year
Measured: 5 year post rehab
Health related quality of life
HeartQoL
Measured: 5 year post rehab
Health status
EQ5D
Measured: 5 year post rehab
Cardiovascular events
Number of new cardiovascular events in the last five years
Measured: 5 year post rehab
Dietary habits
"Hva spiser du" - a norwegian questionnaire developed to assess nutrional habits
Measured: 5 year post rehab
Triglycerides
Bloodsample
Measured: 5 year post rehab
Physical activity
IPAQ
Measured: 5 year post rehab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start7 Feb 2023
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697120
- Sponsor's protocol ID
- OsloMetU
- Status last verified
- Oct 2022
- First submitted
- 3 Nov 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lunde P, Bye A, Grimsmo J, Pripp AH, Ritschel V, Jarstad E, Nilsson BB. Effects of Individualized Follow-Up With an App Postcardiac Rehabilitation: Five-Year Follow-Up of a Randomized Controlled Trial. J Med Internet Res. 2025 Feb 13;27:e60256. doi: 10.2196/60256.
PubMed 39946716
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using a Smartphone Application to Promote Adherence to Healthy Behaviour Post-cardiac Rehabilitation: Five Year Follow-up of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05697120
- Acronym / sponsor ID
- OsloMetU
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac rehabilitation, mHealth, mobile phone app, Lifestyle, Smartphone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Included in the RCT of which this study is built on
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak oxygen uptake
Time frame: 5 year post rehab
Relative VO2peak (ml/kg/min)
14 secondary outcomes
Time to exhaustion
Time frame: 5 year post rehab
Peak incline
Time frame: 5 year post rehab
Peak velocity
Time frame: 5 year post rehab
Bodyweight
Time frame: 5 year post rehab
LDL cholesterol
Time frame: 5 year post rehab
HDL cholesterol
Time frame: 5 year post rehab
Total cholesterol
Time frame: 5 year post rehab
Exercise habits
Time frame: 5 year post rehab
Health related quality of life
Time frame: 5 year post rehab
Health status
Time frame: 5 year post rehab
Cardiovascular events
Time frame: 5 year post rehab
Dietary habits
Time frame: 5 year post rehab
Triglycerides
Time frame: 5 year post rehab
Physical activity
Time frame: 5 year post rehab
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 39946716Lunde P, Bye A, Grimsmo J, Pripp AH, Ritschel V, Jarstad E, Nilsson BB. Effects of Individualized Follow-Up With an App Postcardiac Rehabilitation: Five-Year Follow-Up of a Randomized Controlled Trial. J Med Internet Res. 2025 Feb 13;27:e60256. doi: 10.2196/60256.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (time frame: 5 year post rehab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.