Palliative Care Program for Alzheimer's Disease

(ADRD-PC Trial)

No longer 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?

This trial aims to determine if a special palliative care program, the ADRD-PC Program, can assist people with late-stage Alzheimer's and their caregivers. The program offers tailored hospital care, caregiver education, and post-hospital support. Researchers seek to discover if this approach can reduce stressful hospital visits, improve symptom management, and provide caregivers with more support. Suitable participants include those with late-stage Alzheimer's who are currently hospitalized, along with family caregivers who can communicate in English or Spanish. As an unphased trial, this study allows participants to contribute to innovative care strategies that could enhance the quality of life for both patients and caregivers.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ADRD-PC Program is safe for persons with late-stage Alzheimer's and their family caregivers?

Research has shown that palliative care programs, such as the ADRD-PC program, are generally safe for individuals with late-stage Alzheimer’s and similar dementias. This program offers specialized care tailored to the needs of both patients and their caregivers.

Previous studies have found these types of palliative care to be well-received. They aim to improve quality of life by effectively managing symptoms and supporting families. No reports have linked serious side effects directly to the care provided in these programs.

While the ADRD-PC program seeks to reduce hospital visits and enhance care, safety data from similar programs suggest that participants can expect a supportive experience without major safety concerns.12345

Why are researchers excited about this trial?

The ADRD-PC Program stands out because it offers dementia-specific palliative care through specialized interdisciplinary teams right in the hospital. This approach is different because it not only focuses on the patient but also provides standardized education for caregivers, easing the difficult decisions and concerns they face. Researchers are excited because this program also includes transitional care, facilitating community-based services and offering follow-up support through post-discharge phone calls, which could greatly improve the quality of life for both patients and caregivers compared to the usual care methods.

What evidence suggests that the ADRD-PC Program is effective for late-stage Alzheimer's disease?

Research has shown that the ADRD-PC Program, which participants in this trial may receive, holds promise for individuals with late-stage Alzheimer's Disease and Related Dementias (ADRD). In earlier studies, the program reduced hospital visits and improved symptom management for patients. Caregivers reported better communication and decision-making, which lowered their stress levels. The program includes personalized comfort-focused care and educational support for caregivers, improving support services and reducing the need for nursing home care. These findings suggest that the ADRD-PC Program could significantly benefit patients and their families.16789

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+

Citations

Palliative care for persons with late-stage Alzheimer's and ...The purpose of this study was to conduct a randomized clinical trial (RCT) of the ADRD-Palliative Care (ADRD-PC) program.
Project Details - NIH RePORTERWe 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 ...
Transitional Care of People With Dementia and Caregivers ...This descriptive, multisite study used mixed methods to describe transitional care for caregivers of people with late-stage dementia enrolled in the ADRD-PC ...
Alzheimer's Disease and Other Related DementiasThe purpose of this research study is to develop the Alzheimer's Disease and Related Dementias Palliative Care (ADRD-PC) program for persons with late-stage ...
Transitional Care of People With Dementia and Caregivers in the ...Of 40 dyads of people with late-stage ADRD and their caregivers, palliative care plans were documented for 29 patients (73%); completed postdischarge calls in ...
Project Details - NIH RePORTERWe 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 ...
Palliative Care for Persons with Late-stage Alzheimer's and ...This study evaluates the Alzheimer's Disease and Related Dementias Palliative Care (ADRD-PC) program of care for people with Alzheimer's disease or other ...
Palliative care for persons with late-stage Alzheimer's and ...Intervention dyads will receive the ADRD-PC program of (1) dementia-specific palliative care, (2) standardized caregiver education, and (3) ...
UPLIFT-AD for Alzheimer's DiseaseThe purpose of this study is to evaluate a comprehensive model for integrating both primary and specialty Palliative Care for older adults with dementia ...
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