Back to resultsDigital Health Nudging in Adolescents With Congenital Heart Disease
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Digital Health Nudging
Sponsored by
About this trial
This is an interventional prevention trial for Congenital Heart Disease focused on measuring Physical Activity Promotion, Digital Health Nudging
Eligibility Criteria
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
Sites / Locations
- Department of Congenital Heart Defects and Pediatric Cardiology, German Heart Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Digital Health Nudging
Control
Arm Description
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.
During 12-week control period participants receive no text messages.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Objectively measured daily step count
Daily step count is objectively assessed with the wrist worn wearable "Garmin vivofit jr.".
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.
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.
Full Information
NCT ID
NCT04933786
First Posted
June 14, 2021
Last Updated
January 2, 2023
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Institute of Preventive Pediatrics, Technical University of Munich, Stiftung KinderHerz Deutschland gGmbH
1. Study Identification
Unique Protocol Identification Number
NCT04933786
Brief Title
Digital Health Nudging in Adolescents With Congenital Heart Disease
Official Title
Digital Health Nudging - Daily Smartphone Messages to Increase Physical Activity in Adolescents With Congenital Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Institute of Preventive Pediatrics, Technical University of Munich, Stiftung KinderHerz Deutschland gGmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Physical Activity Promotion, Digital Health Nudging
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digital Health Nudging
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
During 12-week control period participants receive no text messages.
Intervention Type
Behavioral
Intervention Name(s)
Digital Health Nudging
Intervention Description
Short daily text messages with information and motivation concerning physical activity.
Primary Outcome Measure Information:
Title
Objectively measured physical activity
Description
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.
Time Frame
25 weeks
Secondary Outcome Measure Information:
Title
Objectively measured daily step count
Description
Daily step count is objectively assessed with the wrist worn wearable "Garmin vivofit jr.".
Time Frame
25 weeks
Title
Activity-related self-efficacy
Description
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.
Time Frame
Baseline, after 12 weeks, after 24 weeks
Title
Health-related quality of life
Description
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.
Time Frame
Baseline, after 12 weeks, after 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Müller, PD Dr.rer.nat
Organizational Affiliation
Technical university munich, Chair of preventive perdiatrics
Official's Role
Study Director
Facility Information:
Facility Name
Department of Congenital Heart Defects and Pediatric Cardiology, German Heart Center
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80636
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Digital Health Nudging in Adolescents With Congenital Heart Disease
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