Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793138
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-20
First Post:
2023-03-20
Brief Title:
Dialysis Geriatric Care Model
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Integration of Geriatric Care Into Dialysis Clinics
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
None
Brief Summary:
The objectives of this study are to refine the dialysis care model with key stakeholder input and conduct a pilot randomized controlled trial RCT to obtain evidence critical to inform a definitive RCT
Detailed Description:
The investigators designed a new dialysis care model that includes a centralized geriatric team that uses information from the Geriatric screen for OLder Dialysis patients GOLD to develop individualized recommendations for geriatric syndrome management based on the patients priorities The study population is older adults receiving hemodialysis and dialysis staff The investigators will have patient participants complete the care model and undergo geriatric evaluation This phase will be referred to as refinement aim 1 The investigators will then assess agreement of each GOLD instrument with its corresponding geriatric evaluation The investigators will assess acceptability and feasibility of the care model through surveys and interviews with patients and dialysis staff to complete refinement aim 2 Once the new dialysis care model is redefined the investigators will conduct the third phase pilot RCT geriatric care model vs usual care and assess geriatric problem management at 4 months as well as patient reported outcomes physical function and health care utilization at intervals up to 12 months The analyses will include 1 measure of agreement using Cohens kappa 2 qualitative rapid analyses 3 descriptive statistics from acceptability and feasibility surveys 4 descriptive statistics from pilot RCT data and 5 tests for difference in geriatric problem management between treatment and control groups The study does not involve activity from participants that would exceed normal or routine care so there are negligible physical financial or legal risks
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