Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF)

NCT ID: NCT06270875

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-02
• Study Completion Date: 2027-06-30

Brief Summary

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 advancing heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator coach-delivered PC pain intervention components).

Detailed Description

Developing culturally-responsive, effective, efficient, and scalable and unpacking mechanisms of action of heart failure palliative care interventions have been identified a key research priorities by NIH, AHA, and others. To begin to answer questions of mechanism and efficiency, the study team explored the dose effect of ENABLE CHF-PC, a large phase III RCT that demonstrated small improvements in secondary outcomes of pain intensity and interference. These additional exploratory analyses showed that those with poor baseline QOL and high pain intensity who received a full intervention dose had improved outcomes.

However ENABLE CHF-PC and other HF PC studies included interventions designed to be delivered as a "bundled" package where all intervention participants received the same intervention at set times and dose, making it hard to assess which content or dose led to outcome change. To efficiently test multiple intervention components, doses, and intensity simultaneously requires innovative methods and frameworks, like the Multiphase Optimization Strategy (MOST). Guided by the Total Pain Theory and ENABLE CHF-PC and other HF PC and pain interventions, the project team identified 4 intervention components (HF pain and PC education, relaxation training, COPE attitude and other coping skills, health-related communication) and spirituality and meaning making to be modified, adapted, and evaluated for inclusion in a new, lay navigator-led early palliative care pain telehealth intervention, ADAPT HF (ADdressing pain through A navigator led Palliative care opTimized for Heart Failure).

Aim 1: Using the innovative MOST framework, determine ADAPT HF components feasibility, acceptability, enrollment, retention, and completion rates in advanced HF patients (n=36) for 12 weeks. Feasibility: ≥80% of participants will adhere to and complete assigned intervention components and study-related assessments. Acceptability: Through post-intervention qualitative interviews and acceptability outcomes (acceptability of intervention measure and intervention appropriateness measure), the project team will elicit feedback on intervention components, experiences, and clinical trial procedures.

Aim 2: Explore the preliminary efficacy of ADAPT HF intervention components on outcomes at 12- and 24- weeks after baseline including a) pain interference & pain intensity (primary outcome) using PROMIS measures b) symptom burden using the Edmonton Symptom Assessment Scale and c) mood using the Hospital Anxiety and Depression Scale and d) QOL using the Kansas City Cardiomyopathy Scale.

Conditions

Chronic Illness; NYHA Class II-IV Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Coached: Basic pain education + basic communication + spirituality & Self-led: self-care

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: Basic pain education + advanced communication & Self-led: self-care + spirituality

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

Group Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: Basic pain education + advanced communication + spirituality & Self-led: self-care

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: advanced pain education + self-care + basic communication & Self-led: spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: advanced pain education + self-care + basic communication + spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: advanced pain education + self-care + advanced communication & Self-led: spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: advanced pain education + self-care + advanced communication + spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: advanced pain education + basic communication & Self-led: self-care+ spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: Basic pain education + self-care + basic communication & Self-led: spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: Basic pain education + self-care + basic communication + spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: Basic pain education + self-care + advanced communication & Self-led: spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: Basic pain education + self-care + advanced communication + spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: Basic pain education + basic communication & Self-led: self-care + spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: advanced pain education + basic communication + spirituality & Self-led: self-care

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: advanced pain education + advanced communication & Self-led: self-care+ spirituality

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Coached: advanced pain education + advanced communication + spirituality & Self-led: self-care

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 Type: EXPERIMENTAL

ADAPT HF

Intervention Type: BEHAVIORAL

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Interventions

ADAPT HF

ADAPT is a multicomponent, lay palliative care coach-led or self-led supportive care intervention designed to improve pain of life in individuals with advanced heart failure. Participants will complete weekly sessions of the educational programs. This program includes the following modules: pain psychoeducation, self-care and relaxation tips, social support and communication, and spirituality and meaning coping. The sessions will either be self-guided or completed with a lay coach navigator.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18

2. African American

3. Diagnosis of advanced heart failure (New York Heart Association Class II-IV or American College of Cardiology/American Heart Association Stage C-D)

4. English speaking

5. Willing to participate

6. Primary residence in CAPC East South Central or West South Central regions* (Alabama, Mississippi, Tennessee, Kentucky, Arkansas, Louisiana, Oklahoma, Texas)

7. Self-endorses pain in the last month

8. Willing to participate in intervention and data collection

Exclusion Criteria

1. Age <18

2. Not African American

3. Ineligible HF classification

4. Self-reported, untreated severe mental illness

5. Dementia

6. Active Suicidal Ideation

7. Active substance abuse

8. Uncorrected hearing loss

9. Unable to respond in English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Rachel Wells

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

Hillman Emergent Innovation

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300011859

Identifier Type: -

Identifier Source: org_study_id