An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure (NCT05879887) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure
United States64 participantsStarted 2024-08-15
Plain-language 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).
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Intervention Delivery and Data Collection
Timeframe: Baseline to 24 weeks
2
Acceptability of Intervention and Study Procedures