N/A N=78 Randomized Double-blind Supportive Care

Family Palliative and End-of-Life Care for Advanced Heart Failure

Heart Failure NYHA Class III · Heart Failure NYHA Class IV

Bottom Line

View on ClinicalTrials.gov: NCT04153890 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

Feb 2025

Primary outcome: Primary: Patient Heart Failure Health Status (KCCQ)- Baseline — 26.79; 27.11 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FamPALcare (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: West Virginia University
Primary completion: Jul 2023

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	—

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.

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

View full record on ClinicalTrials.gov →

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.