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Behavioral Intervention
Palliative Care Program for Alzheimer's Disease (ADRD-PC Trial)
N/A
Waitlist Available
Led By Laura C Hanson, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
People with ADRD aged 55 or older and hospitalized with a physician-confirmed diagnosis of ADRD and staged GDS 6 or 7; or GDS 5 with additional co-morbidity defined by Charlson Comorbidity Index scored 5 or higher
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days post hospital discharge
Awards & highlights
ADRD-PC Trial Summary
This trial will study if a program of dementia-specific palliative care, standardized caregiver education, and transitional care can reduce burdensome hospital transfers, improve symptom treatment and control, augment supportive services, and reduce nursing home transitions for patients, and improve caregiver outcomes of communication, shared decision-making and distress.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on a care program rather than medication, traditional side effects are not applicable. However, there may be emotional impacts due to changes in caregiving routines.
ADRD-PC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 or older with advanced dementia and have been hospitalized.
ADRD-PC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 days post hospital discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days post hospital discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital Transfers
Secondary outcome measures
Access to community-based palliative care
Access to hospice
Caregiver burden
+9 moreADRD-PC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Condition: ADRD-PC ProgramExperimental Treatment1 Intervention
Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.
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.
Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.
Group II: Control ConditionActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,188 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
28,004,640 Total Patients Enrolled
Laura C Hanson, MD, MPHPrincipal InvestigatorUniversity of North Carolina
2 Previous Clinical Trials
558 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently in palliative care or hospice.I am the legal adult caregiver, can support someone with ADRD, and speak English or Spanish.Participating in this study would not cause me or my caregiver excessive stress.I am 55 or older with advanced dementia and have been hospitalized.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Condition: ADRD-PC Program
- Group 2: Control Condition
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the geographical scope of this clinical trial's implementation?
"At present, the University of North carolina at Chapel Hill in Chapel Hill and Indiana University in Indianapolis are two sites participating. In addition to these locations, there are also two other medical centres involved: the University of Colorado Denver in Denver as well as 4 more trial locales."
Answered by AI
Is this experiment seeking new participants?
"According to information accessible on the clinicaltrials.gov website, this trial is no longer seeking applicants as of July 12th 2022, after initial posting on 26th July 2021. However, there are presently 775 other medical studies actively enrolling patients."
Answered by AI
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