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DementiaADRD-PCNCT04948866

Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers

A study testing ADRD-PC Program in people with Dementia and Dementia, Vascular, run by University of North Carolina, Chapel Hill at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
ADRD-PC Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
884 participants
Where
5 sitesUnited States
Study dates
26 Jul 2021to 1 Feb 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Colorado Denver

    Denver, Colorado, 80045

  • Indiana University

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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.

Read the detailed description

Investigators have designed the ADRD Palliative Care (ADRD-PC) program of dementia-specific palliative and transitional care, and shown its feasibility and potential efficacy. Delivered by interdisciplinary hospital palliative care teams, ADRD-PC addresses 1) prognostic awareness, 2) symptom management, 3) shared decision-making, and 4) transition to community support services.

The research objective is to conduct a multi-site efficacy randomized clinical trial (RCT) of the ADRD-PC program. Investigators will enroll 424 dyads of hospitalized patients with late-stage ADRD (Global Deterioration Scale (GDS) 6-7 or GDS 5 with significant co-morbidity) with their family caregivers, and an additional 50 dyads that identify as Hispanic/Latino at 5 geographically diverse sites of the Palliative Care Research Cooperative group - University of North Carolina, University of Colorado, Massachusetts General Hospital (Harvard University), Indiana University, and Emory University. The primary hypothesis is that ADRD-PC will reduce hospital transfers (Aim 1). Additional hypotheses are that ADRD-PC will improve patient-centered outcomes of symptom treatment, symptom control, use of community palliative care or hospice, and nursing home transitions (Aim 2); and caregiver outcomes of communication, decision-making and distress (Aim 3).

Being tested
ADRD-PC Program
Medical subject headings
Dementia, Dementia, Vascular, Lewy Body Disease, Mixed Dementias, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADRD-PC ProgramBehavioural

    Included in arm/group descriptions

Study groups in NCT04948866
Study groupRoleWhat they receive
Intervention Condition: ADRD-PC ProgramExperimental1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams. 2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions. 3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.
Receives: Behavioral: ADRD-PC Program
Control ConditionActive comparatorPatient-family caregiver dyads randomized to the control arm will receive educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patient will receive usual hospital and post-acute care.
Receives: Behavioral: ADRD-PC Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Hospital Transfers (Patients)

    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.

    Measured: 60 days post index hospital discharge

Secondary outcomes (13)

  1. Symptom Treatment (Patients)

    Palliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment

    Measured: 60 days post hospital discharge

  2. Symptom Control for Physical Symptoms (Patients)

    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.

    Measured: 60 days post hospital discharge

  3. Symptom Control for Neuropsychiatric Symptoms-Severity (Patients)

    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.

    Measured: 60 days post hospital discharge

  4. Symptom Control for Neuropsychiatric Symptoms-Distress (Patients)

    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.

    Measured: 60 days post hospital discharge

  5. Access to Hospice (Patients)

    Percent of people with ADRD who access hospice services.

    Measured: 60 days post hospital discharge

  6. Access to Community-based Palliative Care (Patients)

    Percent of people with ADRD who access community-based palliative care services

    Measured: 60 days post hospital discharge

  7. Transition to Nursing Home Level of Care (Patients)

    Percent of people with ADRD who transition to nursing home care

    Measured: 60 days post hospital discharge

  8. Documented Discussion of Dementia Prognosis (Patients)

    Percent of patients with documented discussion of dementia prognosis in their medical record.

    Measured: 60 days post hospital discharge

  9. Documented Discussion of Goals of Care (Patients)

    Percent of patients with documented discussion of overall goals of care.

    Measured: 60 days post hospital discharge

  10. Shared Decision-making - Hospitalization (Patients)

    Percent of patients whose caregivers reported shared decision-making discussions with a healthcare provider about future hospitalization for the patient.

    Measured: 60 days post hospital discharge

  11. Shared Decision-making - Burdensome Treatment (Patients)

    Percent of patients whose caregivers reported shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment.

    Measured: 60 days post hospital discharge

  12. Caregiver Distress Score (Caregivers)

    Family Distress in Advanced Dementia scale - 21 item Likert scale (1=Never to 5=Always) ranges from 21 to 105 with higher scores indicating more distress.

    Measured: 60 days post hospital discharge

  13. Caregiver Burden (Caregiver)

    Zarit Burden scale, short form - 6 items, Likert (1=never to 5=Nearly Always), range 0-24 with higher scores indicating more caregiver burden.

    Measured: 60 days post hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2021
  2. Study start26 Jul 2021
  3. Primary completion1 Feb 2025
  4. Study completion1 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
884 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04948866
Sponsor's protocol ID
20-2764
Other IDs
R01AG065394
Acronym
ADRD-PC
Status last verified
Feb 2025
First submitted
23 Jun 2021
Last updated
16 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. In addition, every attempt will be made to publish results in peer-reviewed journals. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

  • Toles M, Kistler C, Lin FC, Lynch M, Wessell K, Mitchell SL, Hanson LC. Palliative care for persons with late-stage Alzheimer's and related dementias and their caregivers: protocol for a randomized clinical trial. Trials. 2023 Sep 25;24(1):606. doi: 10.1186/s13063-023-07614-4.

    PubMed 37743478

Questions about this trial

What is this clinical trial studying?

A study testing ADRD-PC Program in people with Dementia and Dementia, Vascular, run by University of North Carolina, Chapel Hill at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Hospital Transfers (Patients) (time frame: 60 days post index hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04948866, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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