Testing the CHAT Program for Patients With Heart Failure

NCT ID: NCT06994325

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-01-01

Brief Summary

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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

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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).

Conditions

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HFpEF - Heart Failure With Preserved Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard of Care Group

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

Group Type ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type 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.

CHAT Intervention Group

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.

Group Type EXPERIMENTAL

Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention

Intervention Type 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.

Interventions

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Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention

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.

Intervention Type BEHAVIORAL

Standard of Care (SOC)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Parag Goyal, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Megan J Shen, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

References

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Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

Reference Type BACKGROUND
PMID: 35363499 (View on PubMed)

Jankowska A, Mlynczak K, Golicki D. Validity of EQ-5D-5L health-related quality of life questionnaire in self-reported diabetes: evidence from a general population survey. Health Qual Life Outcomes. 2021 May 5;19(1):138. doi: 10.1186/s12955-021-01780-2.

Reference Type BACKGROUND
PMID: 33952271 (View on PubMed)

Spertus JA, Jones PG. Development and Validation of a Short Version of the Kansas City Cardiomyopathy Questionnaire. Circ Cardiovasc Qual Outcomes. 2015 Sep;8(5):469-76. doi: 10.1161/CIRCOUTCOMES.115.001958.

Reference Type BACKGROUND
PMID: 26307129 (View on PubMed)

Chen B, Vansteenkiste M, Beyers W, et al. Basic Psychological Need Satisfaction and Frustration Scale. Motivation and Emotion. 2015;

Reference Type BACKGROUND

Mack JW, Block SD, Nilsson M, Wright A, Trice E, Friedlander R, Paulk E, Prigerson HG. Measuring therapeutic alliance between oncologists and patients with advanced cancer: the Human Connection Scale. Cancer. 2009 Jul 15;115(14):3302-11. doi: 10.1002/cncr.24360.

Reference Type BACKGROUND
PMID: 19484795 (View on PubMed)

Riegel B, Lee CS, Dickson VV, Carlson B. An update on the self-care of heart failure index. J Cardiovasc Nurs. 2009 Nov-Dec;24(6):485-97. doi: 10.1097/JCN.0b013e3181b4baa0.

Reference Type BACKGROUND
PMID: 19786884 (View on PubMed)

Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.

Reference Type BACKGROUND
PMID: 15230939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28399031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24039772 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30303894 (View on PubMed)

Other Identifiers

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1R21AG077092-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-07027766

Identifier Type: -

Identifier Source: org_study_id

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