Digital Health Nudging in Adolescents With Congenital Heart Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Behavioral: Digital Health Nudging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Health Nudging<br>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. | Behavioral: Digital Health Nudging<br>* Short daily text messages with information and motivation concerning physical activity.<br>|
| No Intervention: Control<br>During 12-week control period participants receive no text messages. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectively measured physical activity | 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. | 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectively measured daily step count | Daily step count is objectively assessed with the wrist worn wearable Garmin vivofit jr.. | 25 weeks | 
| Activity-related self-efficacy | 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. | Baseline, after 12 weeks, after 24 weeks | 
| Health-related quality of life | 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. | Baseline, after 12 weeks, after 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity Promotion, Digital Health Nudging