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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different combinations of palliative care, including the ADAPT HF program, can help manage pain in Black adults with advanced heart failure. Participants will be randomly assigned to one of 16 groups, each receiving a unique mix of support such as pain education, self-care tips, communication coaching, and spiritual guidance. Those with advanced heart failure who have experienced pain in the last month and live in certain regions of the southern U.S. may be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve pain management strategies for others with similar conditions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the ADAPT HF treatment, part of a supportive care approach for heart failure, has been generally well-tolerated. For example, one study examined a team-based supportive care plan combined with regular heart failure treatment and found positive results without major safety issues. Another study, involving a nurse and social worker team providing remote care for heart failure patients, also reported improvements in quality of life with no serious side effects.

Additionally, adding supportive care to heart failure treatment is a recommended practice, demonstrating safety and effectiveness. These studies suggest that supportive care treatments like ADAPT HF aim to improve the quality of life for heart failure patients without significant risks. However, it is always important to consider personal health and consult a healthcare provider when considering participation in such trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these palliative care treatments for heart failure because they emphasize a holistic approach, integrating pain management, self-care, and spirituality. Unlike traditional treatments that focus primarily on medication and physical interventions, these methods aim to support emotional and spiritual well-being, which can significantly enhance quality of life. The unique delivery through telephone coaching and self-guided sessions makes these treatments accessible and adaptable to individual patient needs. This comprehensive approach could provide a more personalized support system, potentially leading to better outcomes for patients living with heart failure.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that palliative care can greatly improve the quality of life for people with advanced heart failure. The PAL-HF trial found that a team-based palliative care program improved patients' well-being and life satisfaction. Another study found that palliative care reduced hospital visits and improved health outcomes for heart failure patients. This type of care includes help with managing pain, a significant issue for many with heart failure. In this trial, the ADAPT HF program offers various treatment arms, each providing different combinations of sessions led by guides to assist with pain through education, self-care, communication, and spirituality. These combined methods have shown promise in enhancing patient well-being. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. onlinejcf.com onlinejcf.com/article/S1071-9164(24)00882-0/fulltext

Integration of Palliative Care into Heart Failure Care In sum, the data supporting PC to improve a range of important outcomes in HF are reasonably compelling, despite the challenges inherent to studying these ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5731659/

Integration of Palliative Care in Heart Failure - PubMed Central Patients with advanced HF (i.e., ACC/AHA stage D) have an estimated 1-year mortality of 29%, and an estimated 1-year freedom from hospitalization or death of ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06270875/addressing-pain-through-navigator-led-palliative-care-optimized-for-heart-failure-adapt-hf

Addressing Pain Through Navigator-Led Palliative Care ... Thirty-six persons with advanced heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5664956/

The Palliative Care in Heart Failure (PAL-HF) Randomized ... The PAL-HF trial demonstrates that a multidisciplinary palliative care intervention improves quality of life and patient-reported symptoms, and it reduces the ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2813881

Nurse and Social Worker Palliative Telecare Team ... This randomized clinical trial compares differences in quality of life among 306 adults at high risk of death who have COPD, heart failure, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10339463/

Integrating Palliative Care into the Management of Heart ... Integrating palliative care is a recommended best practice for heart failure management; however, confusion persists about what palliative care ...

7. bmcpalliatcare.biomedcentral.com bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-025-01680-y

Study protocol of sustaining home palliative care for patients ... The aim of this mixed methods randomized controlled trial (RCT) is to test the integrated nurse-led intervention bundle of the HF home EOLPC (HF-FamPALhomeCARE)

8. mypcnow.org mypcnow.org/fast-fact/palliative-care-issues-in-heart-failure/

Palliative Care Issues in Heart Failure Symptom prevalence data in HF includes: pain (78%), dyspnea (61%), depression (59%), insomnia (45%), anorexia, (43%), anxiety (30%), constipation (37%), nausea ...