Heart Failure NYHA Class IICHATTNCT05835063
A Study to Improve Physician-Youth Communication and Medical Decision Making
A study testing We Chatt communication tool in people with Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this study is improving patient-centered communication for young people with advanced heart disease. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- What is being tested?
- We Chatt communication tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 7 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Physician Inclusion Criteria:
- Physician participants will be recruited from the Division of Pediatric Cardiology at the University of Michigan. All physicians with dedicated clinical effort will be eligible.
- Eligible physicians must anticipate remaining on staff >1 year
Patient/Caregiver Inclusion Criteria:
- Patients 12-24 years old with heart failure symptoms meeting criteria for New York Heart Association (NYHA) Class II - IV heart failure
- One parent/caregiver of patient participants meeting inclusion criteria will also be eligible
Physician Exclusion Criteria:
- Not a physician at University of Michigan in the Division of Pediatric Cardiology
Patient/Caregiver Exclusion Criteria:
- Patients with significant cognitive/developmental delay with potential to impact study participation will be excluded from the study due to the focus on physician-youth communication.
- Parents and parent/caregivers that are non-English speaking will be excluded from this pilot study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: We Chatt (Communication, Hopes, Action, Tips and Team) A Study to Improve Physician-Youth Communication and Medical Decision Making
The goal of this study is improving patient-centered communication for young people with advanced heart disease.
- Being tested
- We Chatt communication tool, Usual/standard care
- Keywords
- Caregiver/parent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We Chatt communication toolBehavioural
This arm involves the collaborative completion of a 2-page communication preferences document between a primary physician and an adolescent/young adult patient. Physicians will participate in a 1-hour training led by study principal investigator featuring didactic, multimedia, and experiential-based learning to support the facilitation of the WE CHATT intervention with patients.
Usual/standard careBehavioural
Usual/standard care will be provided. Physicians randomized to the control arm will not receive training in the WE CHATT communication intervention.
| Study group | Role | What they receive |
|---|---|---|
| We Chatt communication tool | Experimental | Not described Receives: Behavioral: We Chatt communication tool |
| Usual care | Placebo comparator | Not described Receives: Behavioral: Usual/standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey
Satisfaction was based on the answers for 12 questions in which clinicians selected from a Likert scale from strongly disagree (1) -Strongly agree (5). The scores ranged from 12-60; higher scores indicated greater satisfaction.
Measured: 2 weeks (after intervention)
Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey
Parent/Caregiver completed 12 questions in which participants selected from a Likert scale from Strongly disagree (1) to Strongly agree (5). The scores ranged from 12-60; higher scores indicated greater satisfaction.
Measured: 2 weeks (after intervention)
Secondary outcomes (3)
Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey
Physicians answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best)
Measured: 2 weeks (after intervention)
Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey
Patient/Caregiver answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best)
Measured: 2 weeks (after intervention)
Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians
Number of minutes to complete the intervention was collected on clinician survey.
Measured: 30 minutes (approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start14 Sep 2023
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure NYHA Class IIStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 20 physicians will be recruited. 10 will be randomized to participate in the intervention arm and 10 will be randomized to the control arm. Participants and caretakers will account for approximately 60 enrolled participants that will not be randomized.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Melissa Cousino, University of Michigan
- Investigators
- Melissa Cousino, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835063
- Sponsor's protocol ID
- HUM00231699
- Other IDs
- 5K23HL145096-04
- Acronym
- CHATT
- Status last verified
- Jun 2025
- First submitted
- 17 Apr 2023
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- We Chatt (Communication, Hopes, Action, Tips and Team) A Study to Improve Physician-Youth Communication and Medical Decision Making
- ClinicalTrials.gov ID
- NCT05835063
- Acronym / sponsor ID
- CHATT / HUM00231699
- Keywords
- Caregiver/parent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Posted 18 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is improving patient-centered communication for young people with advanced heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 20 physicians will be recruited. 10 will be randomized to participate in the intervention arm and 10 will be randomized to the control arm. Participants and caretakers will account for approximately 60 enrolled participants that will not be randomized.
| Arm | Type | Receives |
|---|---|---|
| We Chatt communication tool | Experimental | Behavioral: We Chatt communication tool |
| Usual care | Placebo comparator | Behavioral: Usual/standard care |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| We Chatt communication toolThis arm involves the collaborative completion of a 2-page communication preferences document between a primary physician and an adolescent/young adult patient. Physicians will participate in a 1-hour training led by study principal investigator featuring didactic, multimedia, and experiential-based learning to support the facilitation of the WE CHATT intervention with patients. | Behavioural | We Chatt communication tool |
| Usual/standard careUsual/standard care will be provided. Physicians randomized to the control arm will not receive training in the WE CHATT communication intervention. | Behavioural | Usual care |
Primary outcome
Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey
Time frame: 2 weeks (after intervention)
Satisfaction was based on the answers for 12 questions in which clinicians selected from a Likert scale from strongly disagree (1) -Strongly agree (5). The scores ranged from 12-60; higher scores indicated greater satisfaction.
Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey
Time frame: 2 weeks (after intervention)
Parent/Caregiver completed 12 questions in which participants selected from a Likert scale from Strongly disagree (1) to Strongly agree (5). The scores ranged from 12-60; higher scores indicated greater satisfaction.
3 secondary outcomes
Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey
Time frame: 2 weeks (after intervention)
Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey
Time frame: 2 weeks (after intervention)
Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians
Time frame: 30 minutes (approximately)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Melissa Cousino, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing We Chatt communication tool in people with Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by University of Michigan 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?
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 18 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey (time frame: 2 weeks (after intervention)). The study lists 2 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 18 Jun 2025.