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Behavioral Intervention

Palliative Care for Advanced Heart Failure (UPHOLDS 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
-
Recent hospitalization with primary diagnosis of acute, decompensated heart failure (discharged < last 6 months)
Must not have
Non-cardiac terminal illness
Previous palliative care consultation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 weeks after baseline
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test the effectiveness of an intervention called UPHOLDS for improving the quality of life of older adults with advanced heart failure. The trial will involve 64 participants who will receive different

Who is the study for?
This trial is for adults over 50 with advanced heart failure, recently hospitalized for it, and either part of a health disparity group or living in rural areas. They must speak English, be willing to participate fully, and have phone access.
What is being tested?
The UPHOLDS intervention aims to improve life quality in older adults with advanced heart failure through palliative care coaching. It tests different combinations of psychoeducation sessions, financial coaching, specialty consultations, and follow-up calls.
What are the potential side effects?
Since this study focuses on non-medical interventions like education and coaching rather than drugs or medical procedures, traditional side effects are not expected; however participants may experience emotional or psychological responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was hospitalized for worsening heart failure less than 6 months ago.
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I am 50 years old or older.
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My heart failure is severe, limiting my daily activities significantly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a terminal illness that is not related to heart disease.
Select...
I have had a consultation for palliative care.
Select...
I am currently receiving hospice care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 weeks after baseline 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 and Study Procedures
Feasibility of Intervention Delivery and Data Collection
Secondary study objectives
Financial toxicity using the Comprehensive score for financial Toxicity
Mood using the Hospital Anxiety and Depression Scale
Quality of Life using the Kansas City Cardiomyopathy Questionnaire- 12

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: Basic palliative care coaching + outpatient visit + 4 monthly follow-up callsExperimental Treatment1 Intervention
4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months
Group II: Basic palliative care coaching + outpatient visit + 1 monthly follow-up callExperimental Treatment1 Intervention
4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and a single monthly follow-up call
Group III: Basic palliative care coaching + financial coaching + outpatient visit + 4 monthly follow-up callsExperimental Treatment1 Intervention
4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, 1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months
Group IV: Basic palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up callExperimental Treatment1 Intervention
4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, 1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and a single monthly follow-up call
Group V: Basic palliative care coaching + financial coaching + 4 monthly follow-up callsExperimental Treatment1 Intervention
4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, 1 telehealth session on strategies to address healthcare-related financial toxicity, and monthly follow-up calls for 4 months
Group VI: Basic palliative care coaching + financial coaching + 1 monthly follow-up callExperimental Treatment1 Intervention
4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, 1 telehealth session on strategies to address healthcare-related financial toxicity, and a single monthly follow-up call
Group VII: Basic palliative care coaching + 4 monthly follow-up callsExperimental Treatment1 Intervention
4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, and monthly follow-up calls for 4 months
Group VIII: Basic palliative care coaching + 1 monthly follow-up callExperimental Treatment1 Intervention
4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, and a single monthly follow-up call
Group IX: Advanced palliative care coaching + outpatient visit + 4 monthly follow-up callsExperimental Treatment1 Intervention
8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months
Group X: Advanced palliative care coaching + outpatient visit + 1 monthly follow-up callExperimental Treatment1 Intervention
8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and a single monthly follow-up call
Group XI: Advanced palliative care coaching + financial coaching + outpatient visit + 4 monthly followup callsExperimental Treatment1 Intervention
8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions,1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months
Group XII: Advanced palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up callExperimental Treatment1 Intervention
8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, 1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and a single monthly follow-up call
Group XIII: Advanced palliative care coaching + financial coaching + 4 monthly follow-up callsExperimental Treatment1 Intervention
8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, 1 telehealth session on strategies to address healthcare-related financial toxicity, and monthly follow-up calls for 4 months
Group XIV: Advanced palliative care coaching + financial coaching + 1 monthly follow-up callExperimental Treatment1 Intervention
8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, 1 telehealth session on strategies to address healthcare-related financial toxicity, and a single monthly follow-up call
Group XV: Advanced palliative care coaching + 4 monthly follow-up callsExperimental Treatment1 Intervention
8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions and monthly follow-up calls for 4 months
Group XVI: Advanced palliative care coaching + 1 monthly follow-up callExperimental Treatment1 Intervention
8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, and a single monthly follow-up call

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,652 Total Patients Enrolled
10 Trials studying Heart Failure
41,446 Patients Enrolled for Heart Failure
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,515 Total Patients Enrolled
34 Trials studying Heart Failure
12,550 Patients Enrolled for Heart Failure
~43 spots leftby Dec 2025
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