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Behavioral Intervention

Palliative Care for Heart Failure (ADAPT HF Trial)

N/A

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-endorses pain in the last month

Diagnosis of advanced heart failure (New York Heart Association Class III-IV or American College of Cardiology/American Heart Association Stage C-D)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test and improve a palliative care intervention for managing pain in Black adults with advanced heart failure. They will test different combinations of pain management strategies on 36 participants to see which one

Who is the study for?

This trial is for African American adults over 18 with advanced heart failure who have experienced pain in the last month. They must speak English, be willing to participate in the study and data collection, and live in certain regions of the US (Alabama, Mississippi, Tennessee, Kentucky, Arkansas, Louisiana, Oklahoma, Texas).

What is being tested?

The ADAPT-HF trial is testing a palliative care intervention designed to address pain in Black adults with advanced heart failure. Participants will be randomly assigned to one of 16 different combinations of navigator coach-delivered palliative care components.

What are the potential side effects?

Since this study focuses on non-medical interventions like coaching and support from navigators rather than drugs or medical procedures, traditional side effects are not a primary concern. However, participants may experience emotional or psychological responses to discussing their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have experienced pain in the last month.

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My heart failure is severe, limiting my daily activities significantly.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention Measure (AIM)

Feasibility of Intervention Delivery and Data Collection

Feasibility of Intervention Measure

+2 more

Secondary study objectives

Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q

Connor-Davidson Resilience Scale (CD-RISC-10)

Cost/Resource Utilization Form

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups

Experimental Treatment

Group I: Coached: advanced pain education + self-care + basic communication + spiritualityExperimental Treatment1 Intervention

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

Group II: Coached: advanced pain education + self-care + basic communication & Self-led: spiritualityExperimental Treatment1 Intervention

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

Group III: Coached: advanced pain education + self-care + advanced communication + spiritualityExperimental Treatment1 Intervention

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

Group IV: Coached: advanced pain education + self-care + advanced communication & Self-led: spiritualityExperimental Treatment1 Intervention

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

Group V: Coached: advanced pain education + basic communication + spirituality & Self-led: self-careExperimental Treatment1 Intervention

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

Group VI: Coached: advanced pain education + basic communication & Self-led: self-care+ spiritualityExperimental Treatment1 Intervention

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

Group VII: Coached: advanced pain education + advanced communication + spirituality & Self-led: self-careExperimental Treatment1 Intervention

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

Group VIII: Coached: advanced pain education + advanced communication & Self-led: self-care+ spiritualityExperimental Treatment1 Intervention

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

Group IX: Coached: Basic pain education + self-care + basic communication + spiritualityExperimental Treatment1 Intervention

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

Group X: Coached: Basic pain education + self-care + basic communication & Self-led: spiritualityExperimental Treatment1 Intervention

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

Group XI: Coached: Basic pain education + self-care + advanced communication + spiritualityExperimental Treatment1 Intervention

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

Group XII: Coached: Basic pain education + self-care + advanced communication & Self-led: spiritualityExperimental Treatment1 Intervention

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

Group XIII: Coached: Basic pain education + basic communication + spirituality & Self-led: self-careExperimental Treatment1 Intervention

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

Group XIV: Coached: Basic pain education + basic communication & Self-led: self-care + spiritualityExperimental Treatment1 Intervention

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

Group XV: Coached: Basic pain education + advanced communication + spirituality & Self-led: self-careExperimental Treatment1 Intervention

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

Group XVI: Coached: Basic pain education + advanced communication & Self-led: self-care + spiritualityExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met