Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-03-18
Brief Title:
CAPABLE Transplant
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program
Status:
NOT_YET_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:
None
Brief Summary:
The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things 1 To resolve barriers to being classified as active on the Kidney Transplant KT waitlist and 2 as a surgical prehabilitation intervention targeting the pre-frail frail KT waitlist population It consists of two phases- an open label pilot and a randomized waitlist control trial
Detailed Description:
CAPABLE is a multicomponent goal-directed program that reduces physical disability by working with the person and environment but has not been explored in prehabilitation research The purpose of this study is to adapt CAPABLE an existing evidence-based program for functionally and socio-economically vulnerable older adults as a prehabilitation intervention for people with frailty awaiting KT
As in CAPABLE the delivery characteristics of CAPABLE Kidney Transplant consist of an assessment-driven individually tailored package of interventions delivered over the course of 4 months by an occupational therapist OT 6 home visits for 1hour a registered nurse RN 4 home visits for 1hour and a handy worker HW
In earlier phases research team members conducted preliminary activities to design the CAPABLE Kidney Transplant intervention using Human-Centered Design techniques
This study will seek to accomplish two aims
1 To iteratively refine the CAPABLE -Transplant prototype for those currently KT inactive -
2 To pilot test the CAPABLE-Transplant intervention
The investigators will collect feedback during the open label pilot to further refine the intervention that will be tested as part of the randomized control trial
As in CAPABLE the delivery characteristics of CAPABLE Kidney Transplant consist of an assessment-driven individually tailored package of interventions delivered over the course of 4 months by an occupational therapist OT 6 home visits for 1hour a registered nurse RN 4 home visits for 1hour and a handy worker HW
In earlier phases research team members conducted preliminary activities to design the CAPABLE Kidney Transplant intervention using Human-Centered Design techniques
This study will seek to accomplish two aims
1 To iteratively refine the CAPABLE -Transplant prototype for those currently KT inactive -
2 To pilot test the CAPABLE-Transplant intervention
The investigators will collect feedback during the open label pilot to further refine the intervention that will be tested as part of the randomized control trial
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 |
|---|---|---|---|
| K23DK133677-01A1 | NIH | None | httpsreporternihgovquickSearchK23DK133677-01A1 |