Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270875
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2024-02-05
Brief Title:
Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure ADAPT-HF
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPT HF
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 n36 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
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 n36 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None