NCT05697120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
Last Updated

September 11, 2023

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

November 3, 2022

Last Update Submit

September 8, 2023

Conditions

Coronary Artery Disease

Keywords

Cardiac rehabilitationmHealthmobile phone appLifestyleSmartphone

Outcome Measures

Primary Outcomes (1)

  • Peak oxygen uptake

    Relative VO2peak (ml/kg/min)

    5 year post rehab

Secondary Outcomes (14)

  • Time to exhaustion

    5 year post rehab

  • Peak incline

    5 year post rehab

  • Peak velocity

    5 year post rehab

  • Bodyweight

    5 year post rehab

  • LDL cholesterol

    5 year post rehab

  • +9 more secondary outcomes

Eligibility Criteria

Age41 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo Metropolitan University

Oslo, Norway

Location

Related Publications (1)

  • Lunde P, Bye A, Grimsmo J, Pripp AH, Ritschel V, Jarstad E, Nilsson BB. Effects of Individualized Follow-Up With an App Postcardiac Rehabilitation: Five-Year Follow-Up of a Randomized Controlled Trial. J Med Internet Res. 2025 Feb 13;27:e60256. doi: 10.2196/60256.

    PMID: 39946716DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

January 25, 2023

Study Start

February 7, 2023

Primary Completion

September 7, 2023

Study Completion

September 7, 2023

Last Updated

September 11, 2023

Record last verified: 2022-10

Locations

NO(1)