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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05697120
• Other study ID #: OsloMetU
• Status: Completed
• Start date: February 7, 2023
• Est. completion date: September 7, 2023

Study information

• Verified date: October 2022
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 7, 2023
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
Norway	Oslo Metropolitan University	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen uptake	Relative VO2peak (ml/kg/min)	5 year post rehab
Secondary	Time to exhaustion	Time on treadmill measured in seconds	5 year post rehab
Secondary	Peak incline	Incline (%) at treadmill in the end of the test	5 year post rehab
Secondary	Peak velocity	Kilometer per hour in the end of the test	5 year post rehab
Secondary	Bodyweight	Kilograms	5 year post rehab
Secondary	LDL cholesterol	Blood sample	5 year post rehab
Secondary	HDL cholesterol	Blood sample	5 year post rehab
Secondary	Total cholesterol	Blood sample	5 year post rehab
Secondary	Exercise habits	Mean number of exercise sessions each week for the last year	5 year post rehab
Secondary	Health related quality of life	HeartQoL	5 year post rehab
Secondary	Health status	EQ5D	5 year post rehab
Secondary	Cardiovascular events	Number of new cardiovascular events in the last five years	5 year post rehab
Secondary	Dietary habits	"Hva spiser du" - a norwegian questionnaire developed to assess nutrional habits	5 year post rehab
Secondary	Triglycerides	Bloodsample	5 year post rehab
Secondary	Physical activity	IPAQ	5 year post rehab