Clinical trial NCT06994325: Testing the CHAT Program for Patients With Heart Failure
Official title: A Pilot Hybrid Effectiveness-Implementation Trial for the Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HFpEF - Heart Failure With Preserved Ejection Fraction
Keywords: HFpEF
CHAT
Conversations Helpful for Awareness of Illness Trajectory
Effectiveness-Implementation Trial
Heart Failure with Preserved Ejection Fraction
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The researchers are studying whether an intervention that involves video-based educational content and a health coach is acceptable, feasible, and effective for people with Heart Failure with Preserved Ejection Fraction (HFpEF).

Detailed description: This is a pilot randomized controlled trial of 50 subjects that will compare the CHAT intervention (video-based educational content and a health coach) with usual care. Video-based educational content was developed based on Adult Learning Theory and Social Cognitive Theory. Key content areas covered by the videos and health coach will include: HFpEF Overview, Signs and Symptoms of HFpEF, Medication Management, Physical Activity and Diet with HFpEF, and Planning for the Future (Advance Care Planning).

Eligibility criteria: Inclusion Criteria:

1. Male or Female ≥ 60 years old
2. Documentation of HFpEF according to clinical practice guidelines (signs \& symptoms of HF AND ejection fraction ≥50%)

Exclusion Criteria:

1. Previously referred to hospice care
2. Prior completion of advance directives
3. Moderate-severe dementia or psychiatric disorder precluding informed consent.

Primary outcomes:
measure: Mean Change from Baseline on the Self-Care of Heart Failure Index (SCHFI) Summary Score at 90 Days
timeFrame: Baseline, 90 days
Secondary outcomes:
measure: Scores on the Feasibility of Intervention Measure (FIM) at 90 Days
timeFrame: 90 days
measure: Scores on the Intervention Appropriateness Measure (IAM) at 90 Days
timeFrame: 90 days
measure: Scores on the Acceptability of Intervention Measure (AIM) at 90 Days
timeFrame: 90 days
measure: Mean Change from Baseline on the Advance Care Planning Engagement Survey at 90 Days
timeFrame: Baseline, 90 days
measure: Mean Change from Baseline on the Advance Care Planning Readiness Scale at 90 Days
timeFrame: Baseline, 90 days
measure: Mean Change from Baseline for Percentage of Participants Completing a Health Care Proxy Form at 90 days
timeFrame: Baseline, 90 days
measure: Mean Change from Baseline for Percentage of Participants Completing a Living Will Form at 90 days
timeFrame: Baseline, 90 days
measure: Mean Change from Baseline on the Perceived Health Competency Scale (PHCS) at 90 Days
timeFrame: Baseline, 90 days
measure: Mean Change from Baseline on the Patient Activation Measure (PAM) at 90 Days
timeFrame: Baseline, 90 days
measure: Mean Change from Baseline on The Human Connection (THC) Scale at 90 Days
timeFrame: Baseline, 90 days
measure: Mean Change from Baseline on the Basic Psychological Need Satisfaction and Frustration Scale (BPNSF) Relatedness Subscale at 90 Days
timeFrame: Baseline, 90 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Parag Goyal, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutchinson Cancer Center
name: Megan J Shen, PhD
role: PRINCIPAL_INVESTIGATOR
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