N/A
Completed N=78
Family Palliative and End-of-Life Care for Advanced Heart Failure
Heart Failure NYHA Class III · Heart Failure NYHA Class IV
Source: ClinicalTrials.gov NCT04153890 ↗
Enrolled (actual)
78
Serious AEs
2.6%
Results posted
Feb 2025
Primary outcomePrimary: Patient Heart Failure Health Status (KCCQ)- Baseline — 26.79; 27.11 score on a scale
Summary
Overall objective is to test whether the 5-weekly family home palliative and end-of-life care (FamPALcare) intervention educational and supportive sessions will improve rural home end-of-life and palliative care (EOLPC) for advanced heart failure at 6 months follow up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Heart Failure Health Status (KCCQ)- Baseline |
26.79; 27.11 | — |
| PRIMARY Patient Heart Failure Health Status (KCCQ) -3 Month |
54.73; 44.57 | — |
| PRIMARY Patient Heart Failure Health Status (KCCQ)- 6 Month |
59.49; 46.00 | — |
| PRIMARY Patient Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline |
5.71; 5.89 | — |
| PRIMARY Patient Mental Health - Patient Health Questionnaire (PHQ4)- 3 Month |
2.97; 3.90 | — |
| PRIMARY Patient Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month |
2.44; 4.10 | — |
| PRIMARY Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline |
3.52; 4.33 | — |
| PRIMARY Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 3 Month |
2.06; 4.53 | — |
| PRIMARY Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month |
2.69; 4.32 | — |
| PRIMARY Caregiver Quality of Life - SF12V2 Health Survey- Baseline (MCS-12) |
45.85; 43.59 | — |
| PRIMARY Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (MCS-12) |
47.55; 42.32 | — |
| PRIMARY Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (MCS-12) |
47.81; 46.32 | — |
| PRIMARY Caregiver Quality of Life - SF12V2 Health Survey- Baseline (PCS-12) |
42.40; 40.48 | — |
| PRIMARY Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (PCS-12) |
48.98; 40.66 | — |
| PRIMARY Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (PCS-12) |
44.44; 41.87 | — |
| PRIMARY Caregiver Burden (ZBI-12)- Baseline |
8.12; 13.56 | — |
| PRIMARY Caregiver Burden (ZBI-12)- 3 Month |
9.48; 13.38 | — |
| PRIMARY Caregiver Burden (ZBI-12)- 6 Month |
8.12; 9.93 | — |
| SECONDARY FamPALcare Helpfulness Scale |
4.46 | — |
Eligibility Criteria
Inclusion Criteria
- Alert and consent to participate
- Able to read and understand English
- Advanced HF (NYHA III or IV), diagnosed by physician
Exclusion Criteria
- Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD)
- Diagnosed with a terminal illness or dementia, such as Alzheimer's disease
Data sourced from ClinicalTrials.gov (NCT04153890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.