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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Chronic Illness; Heart Failure NYHA Class IV; Heart Failure NYHA Class III

Treatments: Behavioral: ADAPT HF

Study type: Interventional

Funder types: Other

Identifiers

NCT06270875

PROJECT ADAPT-HF

Details and patient eligibility

About

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).

Full 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; at least 2 per condition) 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18
2. African American
3. Diagnosis of advanced heart failure (New York Heart Association Class III-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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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36 participants in 16 patient groups

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF

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

Experimental group

Description:

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

Treatment:

Behavioral: ADAPT HF