Digital Health Nudging in Adolescents With Congenital Heart Disease

Deutsches Herzzentrum Muenchen97 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Congenital Heart Disease

Interventions

Digital Health NudgingBEHAVIORAL

Short daily text messages with information and motivation concerning physical activity.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Congenital Heart Defects and Pediatric Cardiology, German Heart Center

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

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.

Time frame: 25 weeks

Secondary Outcomes

Objectively measured daily step count

Daily step count is objectively assessed with the wrist worn wearable "Garmin vivofit jr.".

Time frame: 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.

Time frame: 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.

Time frame: Baseline, after 12 weeks, after 24 weeks

Data from ClinicalTrials.gov

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