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Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
NA trial testing ADRD-PC Program in Dementia in 884 participants. Completed in 1 February 2025.
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 884 |
| Start date | 26 July 2021 |
| Primary completion | 1 February 2025 |
| Estimated completion | 1 February 2025 |
| Sites | 5 locations across United States |
University of North Carolina, Chapel Hill
55 and older, any sex, with Dementia or Dementia, Vascular. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of hospital transfers (number of emergency room visits + number of hospital admissions )/(person-days of follow-up) within 60 days after discharge from the index hospitalization.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 0.99 | |
| Control Condition | 1.12 |
Palliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 8.06 | ± 2.14 |
| Control Condition | 6.49 | ± 2.27 |
Symptom Management at the End of Life in Dementia (SM-EOLD) - Likert scale, 9 items each scored 0-5, range of 0-45 with higher scores indicating greater symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 21.0 | ± 9.08 |
| Control Condition | 21.8 | ± 9.25 |
Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity Score - 12 items, each symptom reported as present is rated from 1 (mild) to 3 (severe). The range in this subscale is 0-36 with higher scores indicating worse symptom control.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 21.6 | ± 5.83 |
| Control Condition | 21.8 | ± 5.87 |
Neuropsychiatric Inventory Questionnaire (NPI-Q) Distress - 12 items, if the symptom was reported as present the caregiver rated the level of distress they experienced related tot he patient's symptom from 0 (not distressing) to 5 (extremely distressing). This subscale ranges from 0-60, with higher scores indicating more caregiver distress.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 24.9 | ± 13.7 |
| Control Condition | 27.7 | ± 13.8 |
Percent of people with ADRD who access hospice services.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 17.2 | |
| Control Condition | 17.6 |
Percent of people with ADRD who access community-based palliative care services
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 12.7 | |
| Control Condition | 5.9 |
Percent of people with ADRD who transition to nursing home care
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 35.7 | |
| Control Condition | 36.7 |
Percent of patients with documented discussion of dementia prognosis in their medical record.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 80.1 | |
| Control Condition | 14.9 |
Percent of patients with documented discussion of overall goals of care.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 86.9 | |
| Control Condition | 44.8 |
Percent of patients whose caregivers reported shared decision-making discussions with a healthcare provider about future hospitalization for the patient.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 21.7 | |
| Control Condition | 25.8 |
Percent of patients whose caregivers reported shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Condition: ADRD-PC Program | 38.5 | |
| Control Condition | 42.1 |
Time frame: Adverse events were collected from when participants entered the study to 60 days post hospital discharge.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intervention Condition: AD… | Intervention Condition: AD… | Control Condition (Patients) | Control Condition (Caregiv… |
|---|---|---|---|---|---|
| Emotional Distress | Psychiatric disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT04948866 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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