Long-term Effects of Individualized Follow-up With an App for One Year

Sponsor

Oslo Metropolitan University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05697120

Collaborator

(none)

113

Enrollment

Location

3.9

Anticipated Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease

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

Study Type:

Observational

Anticipated Enrollment :

113 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

Peak oxygen uptake [5 year post rehab]
Relative VO2peak (ml/kg/min)

Secondary Outcome Measures

Time to exhaustion [5 year post rehab]
Time on treadmill measured in seconds
Peak incline [5 year post rehab]
Incline (%) at treadmill in the end of the test
Peak velocity [5 year post rehab]
Kilometer per hour in the end of the test
Bodyweight [5 year post rehab]
Kilograms
LDL cholesterol [5 year post rehab]
HDL cholesterol [5 year post rehab]
Total cholesterol [5 year post rehab]
Exercise habits [5 year post rehab]
Mean number of exercise sessions each week for the last year
Health related quality of life [5 year post rehab]
HeartQoL
Health status [5 year post rehab]
EQ5D
Cardiovascular events [5 year post rehab]
Number of new cardiovascular events in the last five years
Dietary habits [5 year post rehab]
"Hva spiser du" - a norwegian questionnaire developed to assess nutrional habits

Eligibility Criteria

Criteria

Ages Eligible for Study:

41 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Included in the RCT of which this study is built on

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo Metropolitan University	Oslo		Norway

Sponsors and Collaborators

Oslo Metropolitan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oslo Metropolitan University

ClinicalTrials.gov Identifier:

NCT05697120

Other Study ID Numbers:

OsloMetU

First Posted:

Jan 25, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Oslo Metropolitan University

Cardiac rehabilitation

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Jan 25, 2023