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Clinical Trials/NCT04933786
NCT04933786
Completed
Not Applicable

Digital Health Nudging - Daily Smartphone Messages to Increase Physical Activity in Adolescents With Congenital Heart Disease

Deutsches Herzzentrum Muenchen1 site in 1 country97 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Deutsches Herzzentrum Muenchen
Enrollment
97
Locations
1
Primary Endpoint
Objectively measured physical activity
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

In adolescents with congenital heart disease physical activity level is reduced which is why promotion to a more active lifestyle with an age-appropriate and modern intervention is needed. In healthy subjects digital health nudging was shown to increase physical activity. However, in adolescents with congenital heart disease such studies have not been conducted yet. In this RCT participants receive daily, short smartphone messages with the primary purpose to increase daily physical activity, which is monitored with a "Garmin vivofit jr." wearable.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
November 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Deutsches Herzzentrum Muenchen
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adolescents aged 12 to 18 years inclusive
  • Presence of a congenital heart defect (must be moderate or complex according to ACC criteria)
  • Presence of written informed consent

Exclusion Criteria

  • Cognitive impairments that inhibit patients from understanding the tasks

Outcomes

Primary Outcomes

Objectively measured physical activity

Time Frame: 25 weeks

Physical activity is objectively assessed with the wrist worn wearable "Garmin vivofit jr.". Daily physical activity is measured on the basis of active minutes in moderate-to-vigorous intensity.

Secondary Outcomes

  • Objectively measured daily step count(25 weeks)
  • Activity-related self-efficacy(Baseline, after 12 weeks, after 24 weeks)
  • Health-related quality of life(Baseline, after 12 weeks, after 24 weeks)

Study Sites (1)

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