HFpEF - Heart Failure With Preserved Ejection FractionNCT06994325

Testing the CHAT Program for Patients With Heart Failure

A study testing Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention in people with HFpEF - Heart Failure With Preserved Ejection Fraction, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: HFpEF - Heart Failure With Preserved Ejection Fraction
What is being tested?: Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 31 Jul 2025to 28 Aug 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Previously referred to hospice care
Prior completion of advance directives; forms uploaded to the EMR in the past 3 years
Moderate-severe dementia or psychiatric disorder precluding informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medical College
New York, New York, 10021

Other trials in United States

About this study

Official title: A Pilot Hybrid Effectiveness-Implementation Trial for the Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention

Read the 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).

Conditions: HFpEF - Heart Failure With Preserved Ejection Fraction
Being tested: Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention, Standard of Care (SOC)
Keywords: HFpEF, CHAT, Conversations Helpful for Awareness of Illness Trajectory, Effectiveness-Implementation Trial, Heart Failure with Preserved Ejection Fraction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conversations Helpful for Awareness of Illness Trajectory (CHAT) InterventionBehavioural
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)Behavioural
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.

Study groups in NCT06994325
Study group	Role	What they receive
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). Receives: 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. Receives: Behavioral: Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 90 days

Secondary outcomes (11)

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.
Measured: 90 days
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 202528 Aug 2026

First posted29 May 2025
Study start31 Jul 2025
Primary completion28 Aug 2026
Study completion28 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for HFpEF - Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06994325
Sponsor's protocol ID: 24-07027766
Other IDs: 1R21AG077092-01A1
Status last verified: Sep 2026
First submitted: 20 May 2025
Last updated: 24 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 35363499
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.
PubMed 33952271
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.
PubMed 26307129
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.
PubMed 19484795
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.
PubMed 19786884
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.
PubMed 15230939
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.
PubMed 28399031
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.
PubMed 24039772
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.
PubMed 30303894

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HFpEF - Heart Failure With Preserved Ejection Fraction trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Hybrid Effectiveness-Implementation Trial for the Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention
ClinicalTrials.gov ID: NCT06994325
Acronym / sponsor ID: 24-07027766
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 31 Jul 2025 (actual)
Primary completion: 28 Aug 2026 (actual)
Study completion: 28 Aug 2026 (actual)
First posted: 29 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard of Care Group	Active comparator	Behavioral: Standard of Care (SOC)Subjects randomized to the standard of care group will receive usual care (and will not receive the CHAT intervention).
CHAT Intervention Group	Experimental	Behavioral: Conversations Helpful for Awareness of Illness Trajectory (CHAT) InterventionThe 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.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

Previously referred to hospice care
Prior completion of advance directives; forms uploaded to the EMR in the past 3 years
Moderate-severe dementia or psychiatric disorder precluding informed consent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Conversations Helpful for Awareness of Illness Trajectory (CHAT) InterventionThe 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.	Behavioural	CHAT Intervention Group
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.	Behavioural	Standard of Care Group

Primary outcome

Mean Change from Baseline on the Self-Care of Heart Failure Index (SCHFI) Summary Score at 90 Days
Time frame: Baseline, 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.

11 secondary outcomes

Scores on the Feasibility of Intervention Measure (FIM) at 90 Days
Time frame: 90 days
Scores on the Intervention Appropriateness Measure (IAM) at 90 Days
Time frame: 90 days
Scores on the Acceptability of Intervention Measure (AIM) at 90 Days
Time frame: 90 days
Mean Change from Baseline on the Advance Care Planning Engagement Survey at 90 Days
Time frame: Baseline, 90 days
Mean Change from Baseline on the Advance Care Planning Readiness Scale at 90 Days
Time frame: Baseline, 90 days
Mean Change from Baseline for Percentage of Participants Completing a Health Care Proxy Form at 90 days
Time frame: Baseline, 90 days
Mean Change from Baseline for Percentage of Participants Completing a Living Will Form at 90 days
Time frame: Baseline, 90 days
Mean Change from Baseline on the Perceived Health Competency Scale (PHCS) at 90 Days
Time frame: Baseline, 90 days
Mean Change from Baseline on the Patient Activation Measure (PAM) at 90 Days
Time frame: Baseline, 90 days
Mean Change from Baseline on The Human Connection (THC) Scale at 90 Days
Time frame: Baseline, 90 days
Mean Change from Baseline on the Basic Psychological Need Satisfaction and Frustration Scale (BPNSF) Relatedness Subscale at 90 Days
Time frame: Baseline, 90 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
Background: PubMed 35363499Heidenreich 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.
Background: PubMed 33952271Jankowska 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.
Background: PubMed 26307129Spertus 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.
BackgroundChen B, Vansteenkiste M, Beyers W, et al. Basic Psychological Need Satisfaction and Frustration Scale. Motivation and Emotion. 2015;
Background: PubMed 19484795Mack 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.
Background: PubMed 19786884Riegel 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.
Background: PubMed 15230939Hibbard 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.
Background: PubMed 28399031Brown 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.
Background: PubMed 24039772Sudore 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.
Background: PubMed 30303894Riegel 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.
Individual participant dataSharing planned: Yes. 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.

Related trials for HFpEF - Heart Failure With Preserved Ejection Fraction

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Parag Goyal, MD, MSc principal investigator

Weill Medical College of Cornell University

Megan J Shen, PhD principal investigator

Fred Hutchinson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change from Baseline on the Self-Care of Heart Failure Index (SCHFI) Summary Score at 90 Days (time frame: Baseline, 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06994325, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.