Congenital Heart DiseaseNCT04933786
Digital Health Nudging in Adolescents With Congenital Heart Disease
A study testing Digital Health Nudging in people with Congenital Heart Disease, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Digital Health Nudging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairments that inhibit patients from understanding the tasks
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Congenital Heart Defects and Pediatric Cardiology, German Heart Center
Munich, Bavaria, 80636
About this study
Official title: Digital Health Nudging - Daily Smartphone Messages to Increase Physical Activity 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Digital Health Nudging
- Keywords
- Physical Activity Promotion, Digital Health Nudging
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health NudgingBehavioural
Short daily text messages with information and motivation concerning physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital Health Nudging |
| Control | No intervention | During 12-week control period participants receive no text messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 25 weeks
Secondary outcomes (3)
Objectively measured daily step count
Daily step count is objectively assessed with the wrist worn wearable "Garmin vivofit jr.".
Measured: 25 weeks
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.
Measured: Baseline, after 12 weeks, after 24 weeks
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.
Measured: Baseline, after 12 weeks, after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, Stiftung KinderHerz Deutschland gGmbH
- Responsible party
- Sponsor
- Investigators
- Jan Müller, PD Dr.rer.nat, Study director, Technical university munich, Chair of preventive perdiatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933786
- Sponsor's protocol ID
- 265/21 S
- Status last verified
- Jan 2023
- First submitted
- 14 Jun 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37030491
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Nudging - Daily Smartphone Messages to Increase Physical Activity in Adolescents With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT04933786
- Acronym / sponsor ID
- 265/21 S
- Conditions
- Congenital Heart Disease
- Keywords
- Physical Activity Promotion, Digital Health Nudging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Technical University of Munich, Stiftung KinderHerz Deutschland gGmbH
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Health Nudging | Experimental | Behavioral: Digital Health NudgingDuring 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. |
| Control | No intervention | –During 12-week control period participants receive no text messages. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Cognitive impairments that inhibit patients from understanding the tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health NudgingShort daily text messages with information and motivation concerning physical activity. | Behavioural | Digital Health Nudging |
Primary outcome
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.
3 secondary outcomes
Objectively measured daily step count
Time frame: 25 weeks
Activity-related self-efficacy
Time frame: Baseline, after 12 weeks, after 24 weeks
Health-related quality of life
Time frame: Baseline, after 12 weeks, after 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 37030491Willinger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Müller, PD Dr.rer.nat study director
Technical university munich, Chair of preventive perdiatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Nudging in people with Congenital Heart Disease, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively measured physical activity (time frame: 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04933786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.