442 Participants Needed

Palliative Care Program for Alzheimer's Disease

(ADRD-PC Trial)

Recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

LC

Laura C Hanson, MD, MPH

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

This trial is for persons aged 55 or older with late-stage Alzheimer's/dementia (GDS stages 5-7) and their family caregivers who can make healthcare decisions. Caregivers must be adults, legally authorized to represent the patient, support them, and complete interviews in English or Spanish. Those already receiving palliative care or hospice are excluded.

Inclusion Criteria

I am the legal adult caregiver, can support someone with ADRD, and speak English or Spanish.
I am 55 or older with advanced dementia and have been hospitalized.

Exclusion Criteria

I am not currently in palliative care or hospice.
Dyads will be excluded if the LAR is not a family caregiver
Dyads will be excluded if the dyad is not successfully randomized.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams, including standardized caregiver education and transitional care.

During hospitalization
In-hospital care

Transitional Care

Facilitation of community-based services and two post-discharge telephone calls by the palliative care team.

60 days post hospital discharge
2 post-discharge telephone calls

Follow-up

Participants are monitored for outcomes such as hospital transfers, symptom treatment, and caregiver outcomes.

60 days post hospital discharge

What Are the Treatments Tested in This Trial?

Interventions

  • ADRD-PC Program
Trial Overview The ADRD Palliative Care (ADRD-PC) program is being tested to see if it reduces hospital transfers, improves symptom management, augments supportive services for patients with dementia, and helps caregivers with communication and decision-making.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Condition: ADRD-PC ProgramExperimental Treatment1 Intervention
Group II: Control ConditionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+
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