Digital Health Nudging in Adolescents With Congenital Heart Disease

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Behavioral: Digital Health Nudging

• Registration Number: NCT04933786
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Digital Health Nudging	Digital Health Nudging	During 12-week intervention period participants receive daily text messages via WhatsApp on their smartphone to encourage them to be physically active in their daily lives.

Primary Outcome Measures

Name	Time	Method
Objectively measured physical activity	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 Outcome Measures

Name	Time	Method
Objectively measured daily step count	25 weeks	Daily step count is objectively assessed with the wrist worn wearable "Garmin vivofit jr.".
Activity-related self-efficacy	Baseline, after 12 weeks, after 24 weeks	Perceived self-efficacy in the context of physical activity is measured using the German version of the Physical Activity Self-Efficacy Scale. The scale consists of eight items, each of which is answered on a five-point Likert scale.
Health-related quality of life	Baseline, after 12 weeks, after 24 weeks	Health-related quality of life is self-assessed via the KINDL® questionnaire. The KINDL® is a generic instrument for assessing health-related quality of life in children and adolescents. The KINDL® is a short, methodologically tested and flexible measurement instrument consisting of 24 questions on the six areas of body/physis, feelings/psychology, self-assessment, family, friends and school.

Trial Locations

Locations (1)

Department of Congenital Heart Defects and Pediatric Cardiology, German Heart Center; 🇩🇪 Munich, Bavaria, Germany