Congenital Heart DiseaseCHASM in ACHDNCT04271358
Peer Coaching Intervention in Young Adults With Congenital Heart Disease
A study testing Peer Health Coaching in people with Congenital Heart Disease and Congenital Heart Defect, run by Duke University at 1 site in United States.
Trial summary
The purpose of the study is to evaluate a peer coaching intervention in young adults with congenital heart disease. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Congenital Heart Disease, Congenital Heart Defect
- What is being tested?
- Peer Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2020to 2 Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-26
- Diagnosis of congenital heart disease
- Patient at a Duke pediatric cardiology clinic
- Access to a smart phone
Who cannot join
- Cognitive delay
- Patient at an adult cardiology clinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer Coaching Adaptive Self-Management Interventions for Young Adults With Congenital Heart Disease
The purpose of the study is to evaluate a peer coaching intervention in young adults with congenital heart disease.
Read the detailed description
Our research team has developed a peer coaching intervention that has been deployed to promote activated self-management for AYAs with several conditions, and this has been modified adolescents and young adults (AYA) with with congenital heart disease (CHD). This study will be conducted over two years and pair AYA with CHD with a peer coach who also has CHD has successfully navigated the transition to adult medical care and over six months will work to promote the motivation for self-care as well as the development of self-management skills. This pilot study will test feasibility and acceptability, as well as preliminary efficacy and long-term effects on successful transfer to adult cardiology.
- Conditions
- Congenital Heart Disease, Congenital Heart Defect
- Being tested
- Peer Health Coaching
- 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.
Peer Health CoachingBehavioural
The Peer Coaching group will receive 6 months of peer health coaching via a secure telephone and text messaging system.
| Study group | Role | What they receive |
|---|---|---|
| Peer Coaching | Experimental | Participant receive a 6 month peer health coaching intervention. Receives: Behavioral: Peer Health Coaching |
| Education only | No intervention | Participants receive education-only material (newsletter) biweekly for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate number of participants enrolled
Evaluate the number of participants contacted about the study who actually enrolled
Measured: Up to 2 months after recruitment closes
Evaluate completion of study
Determine the number of participants who enrolled in the study who completed it
Measured: Up to 8 months after enrollment of each participant
Measure impact on health
Evaluate the number of participant who stated the intervention had a positive impact on their health
Measured: Up to 8 months after enrollment of each participant
Determine change in patient activation
Determine change in patient activation as measured by changes over time on the Patient Activation Measure (PAM)
Measured: baseline, 3 months, 6 months
Determine change in self-management
Determine change in self-management as measured by changes over time in the Partners in health Scale (PIH)
Measured: baseline, 3 months, 6 months
Secondary outcomes (4)
Determine change in transition readiness
Determine the change in transition readiness over 6 months as measured by the Transition Readiness Assessment Questionaire (TRAQ)
Measured: baseline, 3 months, 6 months
Determine change in health related quality of life
Determine the change in health related quality of life over 6 months as measured by the Short-From 12 (SF-12)
Measured: baseline, 3 months, 6 months
Determine change in emotional health
Determine the change in emotional health over 6 months as measured by the Brief Symptom Inventory (BSI)
Measured: baseline, 3 months, 6 months
Evaluate successful transfer of participants from pediatric to adult cardiology care
Evaluate number of participants that transfer from pediatric to adult cardiology care with at least consecutive visits 10 years post study
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start8 Oct 2020
- Primary completion18 Jan 2023
- Study completion2 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Adult Congenital Heart Association
- Responsible party
- Sponsor
- Investigators
- Richard A Krasuski, MD, Principal investigator, Duke UniversityGary Maslow, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271358
- Sponsor's protocol ID
- Pro00103600
- Acronym
- CHASM in ACHD
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2020
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Coaching Adaptive Self-Management Interventions for Young Adults With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT04271358
- Acronym / sponsor ID
- CHASM in ACHD / Pro00103600
- Conditions
- Congenital Heart Disease, Congenital Heart Defect
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Adult Congenital Heart Association
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 2 Mar 2032 (estimated)
- First posted
- 17 Feb 2020 (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.
The purpose of the study is to evaluate a peer coaching intervention in young adults with congenital heart disease.
Detailed description
Our research team has developed a peer coaching intervention that has been deployed to promote activated self-management for AYAs with several conditions, and this has been modified adolescents and young adults (AYA) with with congenital heart disease (CHD). This study will be conducted over two years and pair AYA with CHD with a peer coach who also has CHD has successfully navigated the transition to adult medical care and over six months will work to promote the motivation for self-care as well as the development of self-management skills. This pilot study will test feasibility and acceptability, as well as preliminary efficacy and long-term effects on successful transfer to adult cardiology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)
| Arm | Type | Receives |
|---|---|---|
| Peer Coaching | Experimental | Behavioral: Peer Health CoachingParticipant receive a 6 month peer health coaching intervention. |
| Education only | No intervention | –Participants receive education-only material (newsletter) biweekly for 6 months |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-26
- Diagnosis of congenital heart disease
- Patient at a Duke pediatric cardiology clinic
- Access to a smart phone
Key exclusion criteria (2 listed)
- Cognitive delay
- Patient at an adult cardiology clinic
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 |
|---|---|---|
| Peer Health CoachingThe Peer Coaching group will receive 6 months of peer health coaching via a secure telephone and text messaging system. | Behavioural | Peer Coaching |
Primary outcome
Evaluate number of participants enrolled
Time frame: Up to 2 months after recruitment closes
Evaluate the number of participants contacted about the study who actually enrolled
Evaluate completion of study
Time frame: Up to 8 months after enrollment of each participant
Determine the number of participants who enrolled in the study who completed it
Measure impact on health
Time frame: Up to 8 months after enrollment of each participant
Evaluate the number of participant who stated the intervention had a positive impact on their health
Determine change in patient activation
Time frame: baseline, 3 months, 6 months
Determine change in patient activation as measured by changes over time on the Patient Activation Measure (PAM)
Determine change in self-management
Time frame: baseline, 3 months, 6 months
Determine change in self-management as measured by changes over time in the Partners in health Scale (PIH)
4 secondary outcomes
Determine change in transition readiness
Time frame: baseline, 3 months, 6 months
Determine change in health related quality of life
Time frame: baseline, 3 months, 6 months
Determine change in emotional health
Time frame: baseline, 3 months, 6 months
Evaluate successful transfer of participants from pediatric to adult cardiology care
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- 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.
Richard A Krasuski, MD principal investigator
Duke University
Gary Maslow, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Health Coaching in people with Congenital Heart Disease and Congenital Heart Defect, run by Duke University at 1 site in United States.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluate number of participants enrolled (time frame: Up to 2 months after recruitment closes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.