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Digital Health Nudging in Adolescents With Congenital Heart Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04933786
Enrollment
97
Registered
2021-06-22
Start date
2021-06-01
Completion date
2022-11-01
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

Physical Activity Promotion, Digital Health Nudging

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.

Interventions

BEHAVIORALDigital Health Nudging

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

Sponsors

Technical University of Munich
CollaboratorOTHER
Stiftung KinderHerz Deutschland gGmbH
CollaboratorUNKNOWN
Deutsches Herzzentrum Muenchen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Objectively measured physical activity25 weeksPhysical 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

MeasureTime frameDescription
Objectively measured daily step count25 weeksDaily step count is objectively assessed with the wrist worn wearable Garmin vivofit jr..
Activity-related self-efficacyBaseline, after 12 weeks, after 24 weeksPerceived 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 lifeBaseline, after 12 weeks, after 24 weeksHealth-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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026