N/A
N=884
Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
Dementia · Dementia, Vascular · Dementia With Lewy Bodies · Dementia Frontal · Dementia, Mixed
Bottom Line
View on ClinicalTrials.gov: NCT04948866 ↗Enrolled (actual)
884
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Incidence of Hospital Transfers (Patients) — 0.99; 1.12 events per person day at risk — p=0.522
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ADRD-PC Program (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Hospital Transfers (Patients) |
0.99; 1.12 | 0.522 |
| SECONDARY Symptom Treatment (Patients) |
8.06; 6.49 | <0.001 sig |
| SECONDARY Symptom Control for Physical Symptoms (Patients) |
21.0; 21.8 | 0.402 |
| SECONDARY Symptom Control for Neuropsychiatric Symptoms-Severity (Patients) |
21.6; 21.8 | 0.803 |
| SECONDARY Symptom Control for Neuropsychiatric Symptoms-Distress (Patients) |
24.9; 27.7 | 0.045 sig |
| SECONDARY Access to Hospice (Patients) |
17.2; 17.6 | 0.977 |
| SECONDARY Access to Community-based Palliative Care (Patients) |
12.7; 5.9 | 0.010 sig |
| SECONDARY Transition to Nursing Home Level of Care (Patients) |
35.7; 36.7 | 0.935 |
| SECONDARY Documented Discussion of Dementia Prognosis (Patients) |
80.1; 14.9 | <0.001 sig |
| SECONDARY Documented Discussion of Goals of Care (Patients) |
86.9; 44.8 | <0.001 sig |
| SECONDARY Shared Decision-making - Hospitalization (Patients) |
21.7; 25.8 | 0.417 |
| SECONDARY Shared Decision-making - Burdensome Treatment (Patients) |
38.5; 42.1 | 0.531 |
| SECONDARY Caregiver Distress Score (Caregivers) |
48.5; 52.3 | 0.012 sig |
| SECONDARY Caregiver Burden (Caregiver) |
7.52; 7.44 | 0.876 |
Summary
Millions of Americans have late-stage Alzheimer's and related dementias (ADRD), causing suffering due to loss of awareness of self and family, progressive dependency, physical and neuropsychiatric symptoms, and physical, emotional and financial strain for caregivers. Investigators now propose a multi-site randomized clinical trial of the ADRD Palliative Care (ADRD-PC) program for persons with late-stage ADRD and their family caregivers, triggered during hospitalization. Investigators aim to learn if this program of dementia-specific palliative care, standardized caregiver education, and transitional care is effective to reduce burdensome hospital transfers, improve symptom treatment and control, augment supportive services, and reduce nursing home transitions for patients, and to improve caregiver outcomes of communication, shared decision-making and distress.
Eligibility Criteria
Inclusion Criteria
People with ADRD Inclusion Criteria:
- aged 55 or older
- hospitalized
- have a physician-confirmed diagnosis of ADRD
- staged GDS 6 or 7; or GDS 5 with additional co-morbidity defined by Charlson Comorbidity Index scored 5 or higher
Caregiver Inclusion Criteria:
- the adult (aged 18 or older) legally authorized representative (LAR) for healthcare and have capacity to serve in this role
- support the person with ADRD
- can complete interviews in English or Spanish.
Exclusion Criteria
Dyads will be excluded if
- the LAR is not a family caregiver
- the patient currently receives palliative care or hospice
- patient or caregiver would be unduly stressed
- dyad is not successfully randomized.
Data sourced from ClinicalTrials.gov (NCT04948866). 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.