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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG077092-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on the Feasibility of Intervention Measure (FIM) at 90 Days | This metric uses the FIM, a 4-item survey rated on a 5-point Likert scale, where the lowest score of 1 indicates 'completely disagree' and the highest score of 5 indicates 'completely agree'. Higher scores suggest greater perceived feasibility of the CHAT intervention. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parag Goyal, MD, MSc | Weill Medical College of Cornell University | Principal Investigator |
| Megan J Shen, PhD | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35363499 | Background | 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. | |
| 33952271 |
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Data collected for the CHAT study will be shared only after the publication of findings addressing the study's specific aims. Data generated under this project will be managed in accordance with the policies of Weill Cornell Medicine (WCM) and the NIH, including the NIH Data Sharing Policy and Implementation Guidance. After publication of our main findings, data will be made available for secondary analyses. External researchers may request access to the data by submitting a written proposal outlining the hypotheses to be tested. All data will be de-identified to protect participant confidentiality.
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.
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.
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| ID | Term |
|---|---|
| D008722 | Methods |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| 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. |
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| Scores on the Intervention Appropriateness Measure (IAM) at 90 Days | This measure uses the IAM, a 4-item survey rated on a 5-point Likert scale, where the lowest score of 1 indicates 'completely disagree' and the highest score of 5 indicates 'completely agree'. The IAM assesses perceived appropriateness of the CHAT intervention. Higher scores suggest better perceived alignment with patient needs. | 90 days |
| Scores on the Acceptability of Intervention Measure (AIM) at 90 Days | This measure uses the AIM, a 4-item survey rated on a 5-point Likert scale, where the lowest score of 1 indicates 'completely disagree' and the highest score of 5 indicates 'completely agree'. The AIM evaluates participants' perceptions of the CHAT intervention's acceptability. Higher scores suggest better acceptance by participants. | 90 days |
| Mean Change from Baseline on the Advance Care Planning Engagement Survey at 90 Days | This metric assesses engagement in Advance Care Planning (ACP) using a 4-item survey rated on a 5-point Likert scale, where the lowest score of 1 indicates 'I have never thought about it ' and the highest score of 5 indicates 'I have already done it'. The mean score is calculated, with higher scores indicating increased engagement in ACP. | Baseline, 90 days |
| Mean Change from Baseline on the Advance Care Planning Readiness Scale at 90 Days | This metric assesses readiness in Advance Care Planning (ACP) using an 8-item survey rated on a 7-point Likert scale, where the lowest score of 1 indicates 'strongly disagree' and the highest score of 7 indicates 'strongly agree'. The mean score is calculated, with higher scores indicating increased readiness in ACP. | Baseline, 90 days |
| Mean Change from Baseline for Percentage of Participants Completing a Health Care Proxy Form at 90 days | This measure uses the Advance Directive Completion Question to count the number of participants who complete a health care proxy form, out of the number of total study participants, reflecting their engagement in Advance Care Planning. | Baseline, 90 days |
| Mean Change from Baseline for Percentage of Participants Completing a Living Will Form at 90 days | This measure uses the Advance Directive Completion Question to count the number of participants who complete a living will form, out of the number of total study participants, reflecting their involvement in planning for future healthcare decisions. | Baseline, 90 days |
| Mean Change from Baseline on the Perceived Health Competency Scale (PHCS) at 90 Days | The PHCS is an 8-item survey, rated on a 5-point Likert scale, where the lowest score of 1 indicates 'strongly disagree' and the highest score of 5 indicates 'strongly agree'. Scores are calculated by summing item responses, with higher scores indicating greater perceived ability to manage health. | Baseline, 90 days |
| Mean Change from Baseline on the Patient Activation Measure (PAM) at 90 Days | The PAM is a 10-item survey, rated on a 4-point Likert scale, where the lowest score of 1 indicates 'disagree strongly' and the highest score of 4 indicates 'agree strongly'. Scores are calculated by summing item responses and converting them to an overall activation level, with higher scores indicating greater self-management and engagement in health. | Baseline, 90 days |
| Mean Change from Baseline on The Human Connection (THC) Scale at 90 Days | The Human Connection (THC) Scale measures therapeutic alliance with 16 items rated on a 4-point Likert scale, with the lowest possible score of 1 and the highest possible score of 4. The mean score reflects perceived improvements in the therapeutic relationship. | Baseline, 90 days |
| Mean Change from Baseline on the Basic Psychological Need Satisfaction and Frustration Scale (BPNSF) Relatedness Subscale at 90 Days | This measure uses the Relatedness Subscale of the BPNSF, an 8-item survey rated on a 5-point Likert scale, where the lowest score of 1 indicates 'completely disagree' and the highest score of 5 indicates 'completely agree'. The BPNSF assesses perceived satisfaction and frustration in relationships. Higher scores indicate greater satisfaction. | Baseline, 90 days |
| Background |
| 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. |
| 26307129 | Background | 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. |
| Background | Chen B, Vansteenkiste M, Beyers W, et al. Basic Psychological Need Satisfaction and Frustration Scale. Motivation and Emotion. 2015; |
| 19484795 | 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. |
| 19786884 | Background | 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. |
| 15230939 | Background | 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. |
| 28399031 | Background | 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. |
| 24039772 | Background | 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. |
| 30303894 | 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. |
| D017530 | Health Care Quality, Access, and Evaluation |