Palliative Care for Heart Failure

(ADAPT HF Trial)

Overseen By Kayleigh Curry, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Severe mental illness, Dementia, Suicidal ideation, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

Using the MOST framework, factorial pilot design, and an iterative, community-based process, the purpose of this study is to pilot test to further develop and refine a palliative care (PC) intervention addressing pain of Black adults (age \> 18) with advanced HF. Thirty-six persons with advanced heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator coach-delivered PC pain intervention components).

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ADAPT HF for heart failure?

Research shows that integrating palliative care with heart failure management can improve quality of life and treatment outcomes for patients. This suggests that treatments like ADAPT HF, which involve palliative care, may be beneficial for heart failure patients. ^{1 2 3 4 5}

Is palliative care for heart failure safe for humans?

Palliative care for heart failure has been shown to be safe and well accepted by patients in clinical trials, with improvements in symptoms like pain and quality of life. ^{3 6 7 8 9}

How is the ADAPT HF treatment different from other heart failure treatments?

ADAPT HF is unique because it integrates palliative care, which focuses on improving quality of life and providing emotional support, alongside traditional heart failure management. This approach is not commonly used in heart failure treatment, despite evidence suggesting it can significantly benefit patients. ^{3 10 11 12 13}

Eligibility Criteria

This trial is for African American adults over 18 with advanced heart failure who have experienced pain in the last month. They must speak English, be willing to participate in the study and data collection, and live in certain regions of the US (Alabama, Mississippi, Tennessee, Kentucky, Arkansas, Louisiana, Oklahoma, Texas).

Inclusion Criteria

I am African American.

I have experienced pain in the last month.

I speak English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive navigator-led palliative care intervention addressing pain through various components such as pain education, self-care, communication, and spirituality.

12 weeks

Weekly telephone sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 12 and 24 weeks after baseline.

12 weeks

Treatment Details

Interventions

• ADAPT HF

Trial Overview The ADAPT-HF trial is testing a palliative care intervention designed to address pain in Black adults with advanced heart failure. Participants will be randomly assigned to one of 16 different combinations of navigator coach-delivered palliative care components.

Participant Groups

Group I: Coached: advanced pain education + self-care + basic communication + spirituality Experimental Treatment 1 Intervention

2 telephone weekly sessions on pain psychoeducation, lay coach-led self-care and relaxation tips, 1 session on social support and communication coaching, coach-led spirituality and meaning coping

Group II: Coached: advanced pain education + self-care + basic communication & Self-led: spirituality Experimental Treatment 1 Intervention

2 telephone weekly sessions on pain psychoeducation, lay coach-led self-care and relaxation tips, 1 session on social support and communication coaching, self-guided spirituality and meaning coping

Group III: Coached: advanced pain education + self-care + advanced communication + spirituality Experimental Treatment 1 Intervention

2 telephone weekly sessions on pain psychoeducation, lay coach-led self-care and relaxation tips, 2 sessions on social support and communication coaching, coach-led spirituality and meaning coping

Group IV: Coached: advanced pain education + self-care + advanced communication & Self-led: spirituality Experimental Treatment 1 Intervention

2 telephone weekly sessions on pain psychoeducation, lay coach-led self-care and relaxation tips, 2 sessions on social support and communication coaching, self-guided spirituality and meaning coping

Group V: Coached: advanced pain education + basic communication + spirituality & Self-led: self-care Experimental Treatment 1 Intervention

2 telephone weekly sessions on pain psychoeducation, self-guided self-care and relaxation tips, 1 session on social support and communication coaching, coach-led spirituality and meaning coping

Group VI: Coached: advanced pain education + basic communication & Self-led: self-care+ spirituality Experimental Treatment 1 Intervention

2 telephone weekly sessions on pain psychoeducation, self-guided self-care and relaxation tips, 1 session on social support and communication coaching, self-guided spirituality and meaning coping

Group VII: Coached: advanced pain education + advanced communication + spirituality & Self-led: self-care Experimental Treatment 1 Intervention

2 telephone weekly sessions on pain psychoeducation, self-guided self-care and relaxation tips, 2 sessions on social support and communication coaching, coach-led spirituality and meaning coping

Group VIII: Coached: advanced pain education + advanced communication & Self-led: self-care+ spirituality Experimental Treatment 1 Intervention

2 telephone weekly sessions on pain psychoeducation, self-guided self-care and relaxation tips, 2 sessions on social support and communication coaching, self-guided spirituality and meaning coping

Group IX: Coached: Basic pain education + self-care + basic communication + spirituality Experimental Treatment 1 Intervention

1 telephone weekly session on pain psychoeducation, lay coach-led self-care and relaxation tips, 1 session on social support and communication coaching, coach-led spirituality and meaning coping

Group X: Coached: Basic pain education + self-care + basic communication & Self-led: spirituality Experimental Treatment 1 Intervention

1 telephone weekly session on pain psychoeducation, lay coach-led self-care and relaxation tips, 1 session on social support and communication coaching, self-guided spirituality and meaning coping

Group XI: Coached: Basic pain education + self-care + advanced communication + spirituality Experimental Treatment 1 Intervention

1 telephone weekly session on pain psychoeducation, lay coach-led self-care and relaxation tips, 2 sessions on social support and communication coaching, coach-led spirituality and meaning coping

Group XII: Coached: Basic pain education + self-care + advanced communication & Self-led: spirituality Experimental Treatment 1 Intervention

1 telephone weekly session on pain psychoeducation, lay coach-led self-care and relaxation tips, 2 sessions on social support and communication coaching, self-guided spirituality and meaning coping

Group XIII: Coached: Basic pain education + basic communication + spirituality & Self-led: self-care Experimental Treatment 1 Intervention

1 telephone weekly session on pain psychoeducation, self-guided self-care and relaxation tips, 1 session on social support and communication coaching, coach-led spirituality and meaning coping

Group XIV: Coached: Basic pain education + basic communication & Self-led: self-care + spirituality Experimental Treatment 1 Intervention

1 telephone weekly session on pain psychoeducation, self-guided self-care and relaxation tips, 1 session on social support and communication coaching, self-guided spirituality and meaning coping

Group XV: Coached: Basic pain education + advanced communication + spirituality & Self-led: self-care Experimental Treatment 1 Intervention

1 telephone weekly session on pain psychoeducation, self-guided self-care and relaxation tips, 2 sessions on social support and communication coaching, coach-led spirituality and meaning coping

Group XVI: Coached: Basic pain education + advanced communication & Self-led: self-care + spirituality Experimental Treatment 1 Intervention

1 telephone weekly session on pain psychoeducation, self-guided self-care and relaxation tips, 2 sessions on social support and communication coaching, self-guided spirituality and meaning coping

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

Patients with heart failure (HF) are referred to palliative care (PC) later in their hospital stay compared to cancer patients, with an average delay of 4.6 days before consultation, which may limit the benefits of symptom management.

Despite being less likely to be referred for non-pain symptoms, patients with HF reported significant improvements in dyspnea after PC consultation, indicating that early involvement of PC could enhance symptom relief and overall care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Hospitalized Patients With Heart Failure and Cancer Referred to Palliative Care. Liu, AY., O'Riordan, DL., Marks, AK., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Palliative Care Interventions for Patients with Heart Failure: A Systematic Review and Meta-Analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Hospitalized Patients With Heart Failure and Cancer Referred to Palliative Care. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Hospitalisations for heart failure: increased palliative care referrals - a veterans affairs hospital initiative. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Translating and testing the ENABLE: CHF-PC concurrent palliative care model for older adults with heart failure and their family caregivers. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A Modern Integration of Palliative Care Into the Management of Heart Failure. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Implementing a Palliative Care Intervention for People with Heart Failure: Learnings from a Pilot Randomized Clinical Trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Integrating palliative care into routine care of patients with heart failure: models for clinical collaboration. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Palliative care in congestive heart failure. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Ethics in the treatment of advanced heart failure: palliative care and end-of-life issues. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

The palliative care in heart failure trial: rationale and design. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Social Worker-Aided Palliative Care Intervention in High-risk Patients With Heart Failure (SWAP-HF): A Pilot Randomized Clinical Trial. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Palliative care and hospice in advanced heart failure. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Palliative Care in a Death-Denying Culture: Exploring Barriers to Timely Palliative Efforts for Heart Failure Patients in the Primary Care Setting. [2022]