Chronic IllnessADAPT HFNCT06270875
Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF)
A study testing ADAPT HF in people with Chronic Illness and NYHA Class II-IV Heart Failure, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Illness, NYHA Class II-IV Heart Failure
- What is being tested?
- ADAPT HF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age <18
- Not African American
- Ineligible HF classification
- Self-reported, untreated severe mental illness
- Dementia
- Active Suicidal Ideation
Show all 9Show fewer
- Active substance abuse
- Uncorrected hearing loss
- Unable to respond in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure
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).
Read the 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
- Being tested
- ADAPT HF
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPT HFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: ADAPT HF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Delivery and Data Collection
Proportion of participants who complete assigned intervention components and study-related assessments.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (12)
Edmonton Symptom Assessment Scale (ESES-r)
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.
Measured: Baseline and 12 weeks
Kansas City Cardiomyopathy Questionnaire- Short Form
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.
Measured: Baseline and 12 weeks
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Baseline and 12 weeks
PROMIS General Self-efficacy
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.
Measured: Baseline & 12 weeks
Self-care of Heart Failure Index
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.
Measured: Baseline & 12 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
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.
Measured: Baseline & 12 weeks
Patient Activation Measure (PAM) Short Form
3-items; assesses patient knowledge, skill, and confidence for self-management; not scored; categorical (disagree strongly- agree strongly.
Measured: Baseline & 12 weeks
Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q
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)
Measured: Baseline & 12 weeks
Connor-Davidson Resilience Scale (CD-RISC-10)
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.
Measured: Baseline & 12 weeks
Discrimination in Medical Settings Scale Scale
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.
Measured: Baseline & 12 weeks
Cost/Resource Utilization Form
5-items; Investigator-developed questions- 5 patient-report; 5 related to intervention delivery costs; not scored, more responses indicate receiving more healthcare services.
Measured: Baseline & 12 weeks
SF Global Health Scale
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.
Measured: Baseline & 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start2 Oct 2024
- Primary completion30 Jun 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Wells, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270875
- Sponsor's protocol ID
- IRB-300011859
- Other IDs
- Hillman Emergent Innovation
- Acronym
- ADAPT HF
- Status last verified
- May 2026
- First submitted
- 5 Feb 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure
- ClinicalTrials.gov ID
- NCT06270875
- Acronym / sponsor ID
- ADAPT HF / IRB-300011859
- Conditions
- Chronic Illness, NYHA Class II-IV Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Coached: Basic pain education + self-care + basic communication & Self-led: spirituality | Experimental | Behavioral: ADAPT HF1 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: Basic pain education + self-care + basic communication + spirituality | Experimental | Behavioral: ADAPT HF1 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 + self-care + advanced communication & Self-led: spirituality | Experimental | Behavioral: ADAPT HF1 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 | Experimental | Behavioral: ADAPT HF1 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 + basic communication & Self-led: self-care + spirituality | Experimental | Behavioral: ADAPT HF1 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 | Experimental | Behavioral: ADAPT HF1 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: Basic pain education + advanced communication & Self-led: self-care + spirituality | Experimental | Behavioral: ADAPT HF1 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: Basic pain education + advanced communication + spirituality & Self-led: self-care | Experimental | Behavioral: ADAPT HF1 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: advanced pain education + self-care + basic communication & Self-led: spirituality | Experimental | Behavioral: ADAPT HF2 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 + basic communication + spirituality | Experimental | Behavioral: ADAPT HF2 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: advanced pain education + self-care + advanced communication & Self-led: spirituality | Experimental | Behavioral: ADAPT HF2 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 + self-care + advanced communication + spirituality | Experimental | Behavioral: ADAPT HF2 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 | Experimental | Behavioral: ADAPT HF2 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 | Experimental | Behavioral: ADAPT HF2 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 & Self-led: self-care+ spirituality | Experimental | Behavioral: ADAPT HF2 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: advanced pain education + advanced communication + spirituality & Self-led: self-care | Experimental | Behavioral: ADAPT HF2 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- Age <18
- Not African American
- Ineligible HF classification
- Self-reported, untreated severe mental illness
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAPT HFADAPT 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. | Behavioural | 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 |
Primary outcome
Feasibility of Intervention Delivery and Data Collection
Time frame: Baseline and 12 weeks
Proportion of participants who complete assigned intervention components and study-related assessments.
Acceptability of Intervention Measure (AIM)
Time frame: 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.
PROMIS Pain Intensity Scale
Time frame: 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.
Pain Interference Scale Short Form 6b
Time frame: 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 Measure
Time frame: 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.
12 secondary outcomes
Edmonton Symptom Assessment Scale (ESES-r)
Time frame: Baseline and 12 weeks
Kansas City Cardiomyopathy Questionnaire- Short Form
Time frame: Baseline and 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and 12 weeks
PROMIS General Self-efficacy
Time frame: Baseline & 12 weeks
Self-care of Heart Failure Index
Time frame: Baseline & 12 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline & 12 weeks
Patient Activation Measure (PAM) Short Form
Time frame: Baseline & 12 weeks
Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q
Time frame: Baseline & 12 weeks
Connor-Davidson Resilience Scale (CD-RISC-10)
Time frame: Baseline & 12 weeks
Discrimination in Medical Settings Scale Scale
Time frame: Baseline & 12 weeks
Cost/Resource Utilization Form
Time frame: Baseline & 12 weeks
SF Global Health Scale
Time frame: Baseline & 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAPT HF in people with Chronic Illness and NYHA Class II-IV Heart Failure, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Delivery and Data Collection (time frame: Baseline and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.