Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
ADRD-PC
2 other identifiers
interventional
884
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2021
CompletedFirst Posted
Study publicly available on registry
July 2, 2021
CompletedStudy Start
First participant enrolled
July 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedResults Posted
Study results publicly available
December 16, 2025
CompletedDecember 16, 2025
February 1, 2025
3.5 years
June 23, 2021
October 28, 2025
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (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.
60 days post index hospital discharge
Secondary Outcomes (13)
Symptom Treatment (Patients)
60 days post hospital discharge
Symptom Control for Physical Symptoms (Patients)
60 days post hospital discharge
Symptom Control for Neuropsychiatric Symptoms-Severity (Patients)
60 days post hospital discharge
Symptom Control for Neuropsychiatric Symptoms-Distress (Patients)
60 days post hospital discharge
Access to Hospice (Patients)
60 days post hospital discharge
- +8 more secondary outcomes
Study Arms (2)
Intervention Condition: ADRD-PC Program
EXPERIMENTAL1. 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.
Control Condition
ACTIVE 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.
Interventions
Included in arm/group descriptions
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Colorado Denver
Denver, Colorado, 80045, United States
Emory University
Atlanta, Georgia, 30322, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02215, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
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.
PMID: 37743478DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathryn Wessell, MPH
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Laura C Hanson, MD, MPH
University of North Carolina
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomization allocation to study arms is concealed from all study personnel until the point of randomization assignment. In the ADRD-PC Study, the overall PI (Dr. Hanson) and the research staff Clinical Research Coordinators (CRC) collecting data in 30- and 60-day interviews (data source for primary outcome and most secondary outcomes) are masked to study assignment until planned study arm reveal during final analyses. CRCs will conduct 60-day electronic health record (EHR) reviews only after dyads complete study participation, as EHR content has the potential to reveal study arm assignment. As with most behavioral clinical interventions, participants and care providers cannot be masked.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2021
First Posted
July 2, 2021
Study Start
July 26, 2021
Primary Completion
February 1, 2025
Study Completion
February 1, 2025
Last Updated
December 16, 2025
Results First Posted
December 16, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 9 to 36 months following publication
- Access Criteria
- Data may be requested to achieve aims in an approved proposal by contacting the Palliative Care Research Collaborative Group Data Repository.
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.