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

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: 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 Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo Metropolitan University

Participation Criteria

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

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	Relative VO2peak (ml/kg/min)	5 year post rehab

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University

Study record dates

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

• Keywords: Smartphone; Cardiac rehabilitation; mHealth; Lifestyle; mobile phone app
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• 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