Digital Health Nudging in Adolescents With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04933786
• Other study ID #: 265/21 S
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2023
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Behavioral:
• Digital Health Nudging
Short daily text messages with information and motivation concerning physical activity.

Locations

Country	Name	City	State
Germany	Department of Congenital Heart Defects and Pediatric Cardiology, German Heart Center	Munich	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Institute of Preventive Pediatrics, Technical University of Munich, Stiftung KinderHerz Deutschland gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objectively measured daily step count	Daily step count is objectively assessed with the wrist worn wearable "Garmin vivofit jr.".	25 weeks
Secondary	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
Secondary	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