Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF)
- Conditions
- Chronic IllnessHeart Failure NYHA Class IIIHeart Failure NYHA Class IV
- Interventions
- Behavioral: ADAPT HF
- Registration Number
- NCT06270875
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Coached: Basic pain education + self-care + advanced communication & Self-led: spirituality ADAPT HF 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 Coached: Basic pain education + self-care + advanced communication + spirituality ADAPT HF 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 Coached: Basic pain education + advanced communication & Self-led: self-care + spirituality ADAPT HF 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 Coached: advanced pain education + self-care + basic communication + spirituality ADAPT HF 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 Coached: Basic pain education + self-care + basic communication & Self-led: spirituality ADAPT HF 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 Coached: advanced pain education + self-care + basic communication & Self-led: spirituality ADAPT HF 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 Coached: advanced pain education + self-care + advanced communication & Self-led: spirituality ADAPT HF 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 Coached: advanced pain education + advanced communication & Self-led: self-care+ spirituality ADAPT HF 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 Coached: Basic pain education + advanced communication + spirituality & Self-led: self-care ADAPT HF 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 Coached: Basic pain education + self-care + basic communication + spirituality ADAPT HF 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 Coached: Basic pain education + basic communication & Self-led: self-care + spirituality ADAPT HF 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 Coached: Basic pain education + basic communication + spirituality & Self-led: self-care ADAPT HF 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 Coached: advanced pain education + self-care + advanced communication + spirituality ADAPT HF 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 Coached: advanced pain education + basic communication & Self-led: self-care+ spirituality ADAPT HF 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 Coached: advanced pain education + basic communication + spirituality & Self-led: self-care ADAPT HF 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 Coached: advanced pain education + advanced communication + spirituality & Self-led: self-care ADAPT HF 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
- Primary Outcome Measures
Name Time Method Feasibility of Intervention Measure 12 weeks 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.
PROMIS Pain Intensity Scale Baseline and 12 weeks 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.
Acceptability of Intervention Measure (AIM) 12 weeks 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.
Pain Interference Scale Short Form 6b Baseline and 12 weeks 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.
Feasibility of Intervention Delivery and Data Collection Baseline and 12 weeks Proportion of participants who complete assigned intervention components and study-related assessments.
- Secondary Outcome Measures
Name Time Method PROMIS General Self-efficacy Baseline & 12 weeks 4 items measure self-efficacy (managing problems or events); Minimum score is 0 and maximum score is 100. Higher values indicates greater self-efficacy. Lower values indicate worse self-efficacy.
Self-care of Heart Failure Index Baseline & 12 weeks 22 items; a measure of self-care defined as a naturalistic decision making process. Minimum score is 0 and Maximum score is 100. Higher scores indicate greater self-care adequacy. Lower scores indicate worse self-care adequacy.
Hospital Anxiety and Depression Scale (HADS) Baseline and 12 weeks 14 items total, 7 items measure anxiety (e.g., feeling tense, restless, worry), 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down). Minimum score is 0 and maximum score is 100. Higher scores indicate worse anxiety/depression. Lower scores indicate less depression and anxiety.
Multidimensional Scale of Perceived Social Support (MSPSS) Baseline & 12 weeks 12-items; 2-items; questionnaire to identify an individual's perceived level of social support with family, friends, and significant others. Minimum score is 12 and Maximum score is 84. Higher scores indicate greater perceived social support. Lower scores indicate lower perceived social support.
SF Global Health Scale Baseline & 12 weeks 10-item scale measuring measure self-reported physical, mental and social health. Minimum score is 0 and maximum score is 100. Higher scores indicate better health. Lower scores indicate poorer health.
Edmonton Symptom Assessment Scale (ESES-r) Baseline and 12 weeks A 10-item measuring symptom burden. This tool measures symptom burden on the following domains: pain, tiredness, nausea, lack of appetite, shortness of breath, anxiety, depression, overall well-being and self-reported other problems. Minimum score is 0 and Maximum score is 100. Higher scores indicate more symptom burden. Lower scores indicate less symptom burden.
Kansas City Cardiomyopathy Questionnaire- Short Form Baseline and 12 weeks 12 items total; Measures changes in the quality of life, 5 domains: physical limitations, symptoms, self-efficacy, social interference, and quality of life. Minimum score is 0 and Maximum score is 100. Higher scores indicated better quality of life. Lower scores indicate poorer quality of life.
Patient Activation Measure (PAM) Short Form Baseline & 12 weeks 3-items; assesses patient knowledge, skill, and confidence for self-management; not scored; categorical (disagree strongly- agree strongly.
Connor-Davidson Resilience Scale (CD-RISC-10) Baseline & 12 weeks 10-items; a unidimensional self-reported scale consisting measuring resilience. Minimum score is 0 and Maximum score is 100. Higher scores reflect great resilience Lower scores indicate worse resilience.
Cost/Resource Utilization Form Baseline & 12 weeks 5-items; Investigator-developed questions- 5 patient-report; 5 related to intervention delivery costs; not scored, more responses indicate receiving more healthcare services.
Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q Baseline & 12 weeks 6-item subscale for Religious/Spiritual Coping + 1 overall Q 6-items; measure of religiousness/spirituality; Not scored; Categorical (A great deal- Not at all)
Discrimination in Medical Settings Scale Scale Baseline & 12 weeks 17-items; measure of racial discrimination, scored as a mean. Higher means indicate more reports of racial discrimination in health care. Lower scores indicates lower reports of racial discrimination in healthcare settings.
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States