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An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure

NCT05879887 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-02-05

No results posted yet for this study

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).

Conditions

  • Chronic Illness
  • Heart Failure - NYHA II - IV

Interventions

BEHAVIORAL

UPHOLDS (Utilizing Palliative Care for Heart Failure Optimized using Lay Navigators to Decrease Suffering)

UPHOLDS is a multicomponent, lay palliative care coach-led supportive care intervention designed to improve quality of life in individuals with advanced heart failure. In a series of weekly, one-on-one, 15-20 minute sessions, participants receive psychoeducation on palliative care principles (problem solving, self-care, symptom management, and advanced care planning), financial coaching (orientation to normalizing financial distress, introducing healthcare-related financial terms, exploring financial needs and steps to discussing finances in care decisions, and identifying financial resources in the health system and community), a one-time specialty palliative care outpatient clinic visit, as well as monthly follow-up.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2026-07-30
Completion
2026-07-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05879887 on ClinicalTrials.gov