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OpenTrials
Completed

NCT Number: NCT04933786

Digital Health Nudging in Adolescents With Congenital Heart Disease

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Munich, Bavaria, 80636, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Health Nudging

Behavioral

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

Primary outcomes

  1. Objectively measured physical activity

    Time frame: 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 outcomes

  1. Objectively measured daily step count

    Time frame: 25 weeks

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

  2. Activity-related self-efficacy

    Time frame: 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.

  3. Health-related quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • Stiftung KinderHerz Deutschland gGmbH
  • Technical University of Munich

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2021
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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