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

NCT06270875 | Active Not Recruiting DMC

• 2 other identifiers: IRB-300011859Hillman Emergent Innovation
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Illness; NYHA Class II-IV Heart Failure

Outcome Measures

Primary Outcomes (5)

• Feasibility of Intervention Delivery and Data Collection

  Proportion of participants who complete assigned intervention components and study-related assessments.

  Baseline and 12 weeks

• Acceptability of Intervention Measure (AIM)

  A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Minimum score is 4 and maximum is 20. Higher scores indicate a higher chance of acceptability. Lower scores indicate a lower chance of acceptability.

  12 weeks

• PROMIS Pain Intensity Scale

  Through PROMIS measures, we will explore reports on pain intensity. This includes a 3-item questionnaire on pain intensity and a 6-item question on pain interference over a week. Minimum score is 3 and the maximum score is 15. Higher values indicate higher pain intensity. Lower values indicate lower pain intensity.

  Baseline and 12 weeks

• Pain Interference Scale Short Form 6b

  A 6-item self-reported measure of the consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Minimum score is 6 and maximum score is 30. Higher scores indicate higher pain interference. Lower scores indicate lower pain interference.

  Baseline and 12 weeks

• Feasibility of Intervention Measure

  A 4-items scale that measures implementation outcomes that are often considered "leading indicators" of implementation success. Minimum score is 4 and maximum score is 20. Higher scores indicated higher feasibility and lower scores indicate less feasibility.

  12 weeks

Secondary Outcomes (12)

• Edmonton Symptom Assessment Scale (ESES-r)

  Baseline and 12 weeks

• Kansas City Cardiomyopathy Questionnaire- Short Form

  Baseline and 12 weeks

• Hospital Anxiety and Depression Scale (HADS)

  Baseline and 12 weeks

• PROMIS General Self-efficacy

  Baseline & 12 weeks

• Self-care of Heart Failure Index

  Baseline & 12 weeks

Study Arms (16)

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

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

EXPERIMENTAL

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

Behavioral: ADAPT HF

Interventions

ADAPT HF 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; Coached: Basic pain education + advanced communication + spirituality & Self-led: self-care; Coached: Basic pain education + basic communication & Self-led: self-care + spirituality; Coached: Basic pain education + basic communication + spirituality & Self-led: self-care; Coached: Basic pain education + self-care + advanced communication & Self-led: spirituality; Coached: Basic pain education + self-care + advanced communication + spirituality; Coached: Basic pain education + self-care + basic communication & Self-led: spirituality; Coached: Basic pain education + self-care + basic communication + spirituality; Coached: advanced pain education + advanced communication & Self-led: self-care+ spirituality; Coached: advanced pain education + advanced communication + spirituality & Self-led: self-care; Coached: advanced pain education + basic communication & Self-led: self-care+ spirituality; Coached: advanced pain education + basic communication + spirituality & Self-led: self-care; Coached: advanced pain education + self-care + advanced communication & Self-led: spirituality; Coached: advanced pain education + self-care + advanced communication + spirituality; Coached: advanced pain education + self-care + basic communication & Self-led: spirituality; Coached: advanced pain education + self-care + basic communication + spirituality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• African American
• Diagnosis of advanced heart failure (New York Heart Association Class II-IV or American College of Cardiology/American Heart Association Stage C-D)
• English speaking
• Willing to participate
• Primary residence in CAPC East South Central or West South Central regions\* (Alabama, Mississippi, Tennessee, Kentucky, Arkansas, Louisiana, Oklahoma, Texas)
• Self-endorses pain in the last month
• Willing to participate in intervention and data collection

You may not qualify if:

• Age \<18
• Not African American
• Ineligible HF classification
• Self-reported, untreated severe mental illness
• Dementia
• Active Suicidal Ideation
• Active substance abuse
• Uncorrected hearing loss
• Unable to respond in English

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the palliative care coach involved in delivering the intervention.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 21, 2024
• Study Start: October 2, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)