CClinicalTrials.gg
CompletedNCT05835063CHATTUpdated Jun 18, 2025Results posted

A Study to Improve Physician-Youth Communication and Medical Decision Making

An interventional study of We Chatt communication tool and Usual/standard care in Heart Failure NYHA Class II, Heart Failure NYHA Class III and Heart Failure NYHA Class IV, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

The goal of this study is improving patient-centered communication for young people with advanced heart disease.

02

Conditions studied

  • Heart Failure NYHA Class II
  • Heart Failure NYHA Class III
  • Heart Failure NYHA Class IV

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Keywords

  • Caregiver/parent
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 62 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    We Chatt communication tool

    Behavioral: We Chatt communication tool

  • Placebo comparator
    Usual care

    Behavioral: Usual/standard care

Interventions

  • BehavioralWe Chatt communication tool

    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.

  • BehavioralUsual/standard care

    Usual/standard care will be provided. Physicians randomized to the control arm will not receive training in the WE CHATT communication intervention.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks (after intervention)

  2. 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.

    Time frame: 2 weeks (after intervention)

Secondary outcomes

  1. 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)

    Time frame: 2 weeks (after intervention)

  2. 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)

    Time frame: 2 weeks (after intervention)

  3. Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians

    Number of minutes to complete the intervention was collected on clinician survey.

    Time frame: 30 minutes (approximately)

07

Results

Posted Jun 18, 2025

Participant flow

Participant flow — Overall Study
MilestoneClinician Intervention ArmClinician Control ArmPatientsParent Caregiver
Started1010109
Completed1010109
Not completed0000

Outcome measures

PrimaryPhysician 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.

Time frame:
2 weeks (after intervention)
Reported as:
Mean · score on a scale
Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey
score on a scaleClinicians Intervention
Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey57.4 ± 2.7
PrimaryPatient/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.

Time frame:
2 weeks (after intervention)
Reported as:
Mean · score on a scale
Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey
score on a scalePatientsCaregivers
Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey49.5 ± 5.853.4 ± 5.2
SecondaryPhysician 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)

Time frame:
2 weeks (after intervention)
Reported as:
Median · score on a scale
Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey
score on a scaleClinicians Intervention
Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey9 (9 to 9)
SecondaryPatient/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)

Time frame:
2 weeks (after intervention)
Reported as:
Median · score on a scale
Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey
score on a scalePatientsCaregivers
Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey9 (8 to 9)10 (9 to 10)
SecondaryTime (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians

Number of minutes to complete the intervention was collected on clinician survey.

Time frame:
30 minutes (approximately)
Reported as:
Median · minutes
Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians
minutesClinicians Intervention
Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians15 (15 to 25)

Adverse events

Collected over Up to 28 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Clinician Intervention Arm0/10 (0%)0/10 (0%)0/10 (0%)
Clinician Control Arm0/10 (0%)0/10 (0%)0/10 (0%)
Patients0/10 (0%)0/10 (0%)0/10 (0%)
Parent Caregiver0/9 (0%)0/9 (0%)0/9 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Clinician Intervention ArmClinician Control ArmPatientsParent CaregiverTotal
<=18 years009—9
Between 18 and 65 years10101—21
>=65 years000—0
Sex: Female, Male
Sex: Female, Male(Participants)Clinician Intervention ArmClinician Control ArmPatientsParent CaregiverTotal
Female444719
Male666220
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Clinician Intervention ArmClinician Control ArmPatientsParent CaregiverTotal
Hispanic or Latino010—1
Not Hispanic or Latino10910—29
Unknown or Not Reported000—0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Clinician Intervention ArmClinician Control ArmPatientsParent CaregiverTotal
American Indian or Alaska Native00000
Asian40004
Native Hawaiian or Other Pacific Islander00000
Black or African American00112
White5108831
More than one race10102
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)Clinician Intervention ArmClinician Control ArmPatientsParent CaregiverTotal
United States101010939
08

Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 6, 2023
  • Informed consent form · Feb 9, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05835063
Lead sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Melissa Cousino (Associate Professor of Pediatrics, University of Michigan) — Principal investigator
First posted
Apr 28, 2023
Start date
Sep 14, 2023
Primary completion
Jun 7, 2024
Completion
Jun 7, 2024
Results posted
Jun 18, 2025
Last update
Jun 18, 2025

Study contacts

Melissa Cousino, PhD
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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