Digital Health Nudging in Adolescents With Congenital Heart Disease

NCT04933786 | Completed

• 1 other identifier: 265/21 S
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Physical Activity Promotion; Digital Health Nudging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Objectively measured daily step count

  25 weeks

• Activity-related self-efficacy

  Baseline, after 12 weeks, after 24 weeks

• Health-related quality of life

  Baseline, after 12 weeks, after 24 weeks

Study Arms (2)

Digital Health Nudging

EXPERIMENTAL

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

Control

NO INTERVENTION

During 12-week control period participants receive no text messages.

Interventions

Digital Health Nudging BEHAVIORAL

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

Digital Health Nudging

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairments that inhibit patients from understanding the tasks

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Technical University of Munich: collaborator
• Stiftung KinderHerz Deutschland gGmbH: collaborator

Study Sites (1)

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

Munich, Bavaria, 80636, Germany

Location

Related Publications (1)

• Willinger L, Oberhoffer-Fritz R, Ewert P, Muller J. Digital Health Nudging to increase physical activity in pediatric patients with congenital heart disease: A randomized controlled trial. Am Heart J. 2023 Aug;262:1-9. doi: 10.1016/j.ahj.2023.04.001. Epub 2023 Apr 7.

  PMID: 37030491 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jan Müller, PD Dr.rer.nat

  Technical university munich, Chair of preventive perdiatrics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: June 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)