Clinical trial NCT05697120: Long-term Effects of Individualized Follow-up With an App for One Year
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Cardiac rehabilitation
mHealth
mobile phone app
Lifestyle
Smartphone
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 102
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Peak oxygen uptake
timeFrame: 5 year post rehab
Secondary outcomes:
measure: Time to exhaustion
timeFrame: 5 year post rehab
measure: Peak incline
timeFrame: 5 year post rehab
measure: Peak velocity
timeFrame: 5 year post rehab
measure: Bodyweight
timeFrame: 5 year post rehab
measure: LDL cholesterol
timeFrame: 5 year post rehab
measure: HDL cholesterol
timeFrame: 5 year post rehab
measure: Total cholesterol
timeFrame: 5 year post rehab
measure: Exercise habits
timeFrame: 5 year post rehab
measure: Health related quality of life
timeFrame: 5 year post rehab
measure: Health status
timeFrame: 5 year post rehab
measure: Cardiovascular events
timeFrame: 5 year post rehab
measure: Dietary habits
timeFrame: 5 year post rehab
measure: Triglycerides
timeFrame: 5 year post rehab
measure: Physical activity
timeFrame: 5 year post rehab
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Metropolitan University
Study officials:
References: