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

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT05697120
• Lead Sponsor: Oslo Metropolitan University

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.

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 Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-25
• Study Start: 2023-02-07
• Primary Completion: 2023-09-07
• Study Completion: 2023-09-07
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Included in the RCT of which this study is built on

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak oxygen uptake	5 year post rehab	Relative VO2peak (ml/kg/min)

Secondary Outcome Measures

Name	Time	Method
Peak incline	5 year post rehab	Incline (%) at treadmill in the end of the test
Time to exhaustion	5 year post rehab	Time on treadmill measured in seconds
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	Blood sample
HDL cholesterol	5 year post rehab	Blood sample
Total cholesterol	5 year post rehab	Blood sample
Exercise habits	5 year post rehab	Mean number of exercise sessions each week for the last year
Triglycerides	5 year post rehab	Bloodsample
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
Physical activity	5 year post rehab	IPAQ

Trial Locations

Locations (1)

Oslo Metropolitan University; 🇳🇴 Oslo, Norway