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

Study acronym: UPHOLDS
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Final enrollment: 32 participants (planned 64) · Eligibility criteria revised · Secondary endpoints: details revised at 1 of 3 entries · 1 more Show 4 more changesShow less
    • Final enrollment: 32 participants (planned 64)
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description revised
  2. Primary and study completion dates: Jul 30, 2026 to Aug 1, 2026v21
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting Primary completion date: Mar 30, 2026 to Jul 30, 2026 · Completion date: Apr 1, 2026 to Jul 30, 2026v20 Show 2 more changesShow less
    • Primary completion date: Mar 30, 2026 to Jul 30, 2026
    • Completion date: Apr 1, 2026 to Jul 30, 2026
  4. Primary completion date: Mar 1, 2026 to Mar 30, 2026 Eligibility criteria shortened, about 22 words · Study description revisedv19 Show 2 more changesShow less
    • Eligibility criteria shortened, about 22 words
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Dec 1, 2025 to Mar 1, 2026v18
Show 16 earlier versionsHide 16 earlier versions
  1. Trial status: Recruiting to Enrolling by Invitation Site details revisedv17 Show 1 more changeShow less
    • Site details revised
  2. 2 versions Re-verified since Aug 15, 2024, no change to tracked fieldsv15-v16
  3. Start date: Jul 15, 2024 to Aug 15, 2024v14
  4. Start date: May 15, 2024 to Jul 15, 2024v13
  5. Start date: Apr 19, 2024 to May 15, 2024v12
  6. Start date: Mar 25, 2024 to Apr 19, 2024v11
  7. Start date: Feb 26, 2024 to Mar 25, 2024v10
  8. Start date: Feb 15, 2024 to Feb 26, 2024v9
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Feb 1, 2024 to Feb 15, 2024v8 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Feb 1, 2024 to Feb 15, 2024
  10. Start date: Dec 15, 2023 to Feb 1, 2024v7
  11. Start date: Nov 15, 2023 to Dec 15, 2023v6
  12. Start date: Oct 15, 2023 to Nov 15, 2023v5
  13. Start date: Sep 1, 2023 to Oct 15, 2023 Primary completion date: Oct 1, 2025 to Dec 1, 2025 · Completion date: Jan 1, 2026 to Apr 1, 2026v4 Show 2 more changesShow less
    • Primary completion date: Oct 1, 2025 to Dec 1, 2025
    • Completion date: Jan 1, 2026 to Apr 1, 2026
  14. Start date: Aug 1, 2023 to Sep 1, 2023v3
  15. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05879887
Lead Sponsor University of Alabama at Birmingham
Collaborators: National Institute of Nursing Research (NINR)
Conditions Chronic Illness, Heart Failure - NYHA II - IV
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov