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Active Not Recruiting
NCT05879887
An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure
Conditions: Chronic Illness, Heart Failure - NYHA II - IV
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 64
Sponsor: University of Alabama at Birmingham
Location: University of Alabama at Birmingham Birmingham Alabama
Summary
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial pilot trial is to identify feasibility, acceptability, and preliminary efficacy of components of an intervention (UPHOLDS) to improve quality of life of older adults with advancing heart failure. Using a 2x2x2x2 factorial design, 64 adults with advancing heart failure will be randomized to receive one or more palliative care coach-delivered components, based on Ferrans' Health-Related Quality of Life Model: 1) psychoeducation on palliative care principles (4 vs. 8 sessions); 2) financial coaching (yes vs. no); 3) one-time specialty outpatient palliative care consultation (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).
Eligibility Criteria
Inclusion Criteria:
1\) Age ≥50 years; 2) Living with heart failure, defined as New York Heart Association Class II-IV or American Heart Association Stage C/D OR Recent hospitalization with primary diagnosis of acute, decompensated heart failure (discharged \< last 6 months); 3) English speaking; 4) Willingness to participate in intervention and complete data collection calls; 5) Telephone access.
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Exclusion Criteria:
1\) Self-reported severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, or active substance abuse; 2) LVAD placement; 3) Non-cardiac terminal illness; 4) Previous palliative care consultation; 5) Receiving hospice
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Source: ClinicalTrials.gov (NCT05879887). StuddyBuddy aggregates publicly available trial information.