Clinical trial NCT06270875: Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF)
Official title: Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Chronic Illness
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 advanced 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; 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.

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

Primary outcomes:
measure: Feasibility of Intervention Delivery and Data Collection
timeFrame: Baseline and 12 weeks
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 12 weeks
measure: PROMIS Pain Intensity Scale
timeFrame: Baseline and 12 weeks
measure: Pain Interference Scale Short Form 6b
timeFrame: Baseline and 12 weeks
measure: Feasibility of Intervention Measure
timeFrame: 12 weeks
Secondary outcomes:
measure: Edmonton Symptom Assessment Scale (ESES-r)
timeFrame: Baseline and 12 weeks
measure: Kansas City Cardiomyopathy Questionnaire- Short Form
timeFrame: Baseline and 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and 12 weeks
measure: PROMIS General Self-efficacy
timeFrame: Baseline & 12 weeks
measure: Self-care of Heart Failure Index
timeFrame: Baseline & 12 weeks
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline & 12 weeks
measure: Patient Activation Measure (PAM) Short Form
timeFrame: Baseline & 12 weeks
measure: Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q
timeFrame: Baseline & 12 weeks
measure: Connor-Davidson Resilience Scale (CD-RISC-10)
timeFrame: Baseline & 12 weeks
measure: Discrimination in Medical Settings Scale Scale
timeFrame: Baseline & 12 weeks
measure: Cost/Resource Utilization Form
timeFrame: Baseline & 12 weeks
measure: SF Global Health Scale
timeFrame: Baseline & 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: