Digital Health Nudging in Adolescents With Congenital Heart Disease

NCT ID: NCT04933786

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Digital Health Nudging

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.

Group Type EXPERIMENTAL

Digital Health Nudging

Intervention Type BEHAVIORAL

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital Health Nudging

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role collaborator

Stiftung KinderHerz Deutschland gGmbH

UNKNOWN

Sponsor Role collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Müller, PD Dr.rer.nat

Role: STUDY_DIRECTOR

Technical university munich, Chair of preventive perdiatrics

Locations

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

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 37030491 (View on PubMed)

Other Identifiers

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265/21 S

Identifier Type: -

Identifier Source: org_study_id

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