Testing the CHAT Program for Patients With Heart Failure
NCT ID: NCT06994325
Last Updated: 2025-08-14
Study Results
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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ENROLLING_BY_INVITATION
NA
50 participants
INTERVENTIONAL
2025-07-31
2026-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
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).
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Documentation of HFpEF according to clinical practice guidelines (signs \& symptoms of HF AND ejection fraction ≥50%)
Exclusion Criteria
2. Prior completion of advance directives
3. Moderate-severe dementia or psychiatric disorder precluding informed consent.
60 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Weill Medical College of Cornell University
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
Chen B, Vansteenkiste M, Beyers W, et al. Basic Psychological Need Satisfaction and Frustration Scale. Motivation and Emotion. 2015;
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.
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.
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.
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.
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.
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.
Other Identifiers
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24-07027766
Identifier Type: -
Identifier Source: org_study_id
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