Ignite Creation Date:
2024-05-06 @ 4:19 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04948866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2021-06-23
Brief Title:
Palliative Care for Persons With Late-stage Alzheimers and Related Dementias and Their Caregivers
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Palliative Care for Persons With Late-stage Alzheimers and Related Dementias and Their Caregivers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADRD-PC
Brief Summary:
Millions of Americans have late-stage Alzheimers 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
Detailed Description:
Investigators have designed the ADRD Palliative Care ADRD-PC program of dementia-specific palliative and transitional care and shown its feasibility and potential efficacy Delivered by interdisciplinary hospital palliative care teams ADRD-PC addresses 1 prognostic awareness 2 symptom management 3 shared decision-making and 4 transition to community support services
The research objective is to conduct a multi-site efficacy randomized clinical trial RCT of the ADRD-PC program Investigators will enroll 424 dyads of hospitalized patients with late-stage ADRD Global Deterioration Scale GDS 6-7 or GDS 5 with significant co-morbidity with their family caregivers and an additional 50 dyads that identify as HispanicLatino at 5 geographically diverse sites of the Palliative Care Research Cooperative group - University of North Carolina University of Colorado Massachusetts General Hospital Harvard University Indiana University and Emory University The primary hypothesis is that ADRD-PC will reduce hospital transfers Aim 1 Additional hypotheses are that ADRD-PC will improve patient-centered outcomes of symptom treatment symptom control use of community palliative care or hospice and nursing home transitions Aim 2 and caregiver outcomes of communication decision-making and distress Aim 3
The research objective is to conduct a multi-site efficacy randomized clinical trial RCT of the ADRD-PC program Investigators will enroll 424 dyads of hospitalized patients with late-stage ADRD Global Deterioration Scale GDS 6-7 or GDS 5 with significant co-morbidity with their family caregivers and an additional 50 dyads that identify as HispanicLatino at 5 geographically diverse sites of the Palliative Care Research Cooperative group - University of North Carolina University of Colorado Massachusetts General Hospital Harvard University Indiana University and Emory University The primary hypothesis is that ADRD-PC will reduce hospital transfers Aim 1 Additional hypotheses are that ADRD-PC will improve patient-centered outcomes of symptom treatment symptom control use of community palliative care or hospice and nursing home transitions Aim 2 and caregiver outcomes of communication decision-making and distress Aim 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG065394 | NIH | None | httpsreporternihgovquickSearchR01AG065394 |