Testing the CHAT Program for Patients With Heart Failure

NCT06994325 | Enrolling By Invitation

• 2 other identifiers: 24-070277661R21AG077092-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline on the Self-Care of Heart Failure Index (SCHFI) Summary Score at 90 Days

  This measure uses the SCHFI, a 29-item survey that evaluates three subscales: Symptom Perception, Self-Care Management, and Self-Care Maintenance, with the lowest possible score of 0 and the highest possible score of 100. Higher scores indicate better self-care. Standardized scoring will assess changes from baseline.

  Baseline, 90 days

Secondary Outcomes (11)

• Scores on the Feasibility of Intervention Measure (FIM) at 90 Days

  90 days

• Scores on the Intervention Appropriateness Measure (IAM) at 90 Days

  90 days

• Scores on the Acceptability of Intervention Measure (AIM) at 90 Days

  90 days

• Mean Change from Baseline on the Advance Care Planning Engagement Survey at 90 Days

  Baseline, 90 days

• Mean Change from Baseline on the Advance Care Planning Readiness Scale at 90 Days

  Baseline, 90 days

Study Arms (2)

Standard of Care Group

ACTIVE COMPARATOR

Subjects randomized to the standard of care group will receive usual care (and will not receive the CHAT intervention).

Behavioral: Standard of Care (SOC)

CHAT Intervention Group

EXPERIMENTAL

The group randomized to the CHAT intervention will be instructed to watch 7 short patient-facing videos and participate in four biweekly sessions with a trained health coach.

Behavioral: Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention

Interventions

Standard of Care (SOC) BEHAVIORAL

The Standard of Care Group will not have access to the Health Coach or video-based educational content. This group will have no study activities during Weeks 1-7 but will participate in follow-up assessments.

Standard of Care Group

Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention BEHAVIORAL

The Conversations Helpful for Awareness of illness Trajectory (CHAT) intervention will incorporate 4 health-coach sessions, supplemented by 7 educational videos. Each session will be up to 60 minutes long and will be conducted remotely. During the health coach sessions, a trained health coach will work with subjects, reviewing the content of each video and emphasizing key learning content.

CHAT Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female ≥ 60 years old
• Documentation of HFpEF according to clinical practice guidelines

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Related Publications (10)

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• Brown AJ, Shen MJ, Urbauer D, Taylor J, Parker PA, Carmack C, Prescott L, Rosemore C, Kolawole E, Sun C, Ramondetta L, Bodurka DC. The Advance Care Planning Readiness Scale: Development and Validation of a Measure of Willingness to Discuss and Acceptance of End-of-Life Care in Gynecologic Cancer Patients. Int J Gynecol Cancer. 2017 May;27(4):838-846. doi: 10.1097/IGC.0000000000000953.

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• Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013 Sep 5;8(9):e72465. doi: 10.1371/journal.pone.0072465. eCollection 2013.

  PMID: 24039772 BACKGROUND

• Riegel B, Barbaranelli C, Carlson B, Sethares KA, Daus M, Moser DK, Miller J, Osokpo OH, Lee S, Brown S, Vellone E. Psychometric Testing of the Revised Self-Care of Heart Failure Index. J Cardiovasc Nurs. 2019 Mar/Apr;34(2):183-192. doi: 10.1097/JCN.0000000000000543.

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MeSH Terms

Interventions

Methods; Standard of Care

Intervention Hierarchy (Ancestors)

Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Parag Goyal, MD, MSc

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Megan J Shen, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 11, 2026
• Study Completion (Estimated): July 11, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be shared after we have published the specific aims of this study. There is no end date to access the data from the research project.
• Access Criteria: Researchers granted access to the data will be required to use it solely for research purposes, ensuring that no individual participants are identifiable. They must also implement appropriate security measures, such as using password-protected servers and files, to safeguard the data. Upon completion of the analyses, the data must be returned or destroyed. Released datasets will be subject to stringent safeguards to ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA). Additionally, a data-sharing agreement will be required, specifying that the data is used exclusively for research purposes and that no participants are identifiable. A data management plan will also be necessary to ensure the continued security and confidentiality of the data, as well as to outline the process for returning or destroying the data once the analysis is complete.

Locations

US (1)