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

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT04948866
Status
Completed

Conditions

  • Alzheimer Disease
  • Dementia
  • Dementia Alzheimers
  • Dementia Frontal
  • Dementia Severe
  • Dementia With Lewy Bodies
  • Dementia, Mixed
  • Dementia, Vascular

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADRD-PC Program — BEHAVIORAL
    Included in arm/group descriptions

Study Details

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.

Key Dates

Start date
Jul 26, 2021
Status verified
Feb 2025
Primary completion
Feb 1, 2025
Completion
Feb 1, 2025

Study Design

Enrollment
884 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Condition: ADRD-PC Program
    1. 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.
  • Active Comparator: Control Condition
    Patient-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.

Primary Outcome Measure

Incidence of Hospital Transfers (Patients) [ Time Frame: 60 days post index hospital discharge ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado DenverDenverColorado80045-
Emory UniversityAtlantaGeorgia30322-
Indiana UniversityIndianapolisIndiana46202-
Massachusetts General HospitalBostonMassachusetts02215-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-

Find similar trials in Denver, CO

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Colorado Denver· Denver, COEmory University· Atlanta, GAIndiana University· Indianapolis, INMassachusetts General Hospital· Boston, MAUniversity of North Carolina at Chapel Hill· Chapel Hill, NC

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