Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-18 @ 8:42 AM
Study NCT ID:
NCT07221604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-28
First Post:
2025-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Agenda-Setting for Kidney Disease Open Pilot Trial
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Study Overview
Official Title:
Setting the Agenda: An Open Pilot of a Structured Clinical Visit Agenda-Setting Intervention for Rural-Residing People With Advanced Chronic Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
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:
ASK
Brief Summary:
The goal of this open pilot is to practice using an intervention and surveys before a larger pilot stepped wedge clinical trial. The intervention the researchers plan to use is Chronic Kidney Disease (CKD) Topics, and it is a structured clinical agenda-setting intervention (SAS), or a customized list of discussion topics. The people the researchers are practicing using the SAS with have advanced CKD (stages 4-5), and many of them live in rural areas. The researchers will practice administering CKD Topics, along with survey questions. By doing the open pilot, the researchers will learn if they need to modify the steps they plan to take in the larger trial.
The main questions the researchers aim to answer are:
* Do the steps for identifying eligible participants work?
* Do the steps for administering CKD Topics work?
* Do the steps to administer survey questions work?
The main questions the researchers aim to answer are:
* Do the steps for identifying eligible participants work?
* Do the steps for administering CKD Topics work?
* Do the steps to administer survey questions work?
Detailed Description:
In this open pilot, the researchers will administer a novel structured agenda-setting tool (SAS) called Chronic Kidney Disease (CKD) Topics. The researchers will determine if their procedures for screening eligible participants, administering the intervention, and administering outcome and other questionnaires are appropriate. Learnings from the open pilot will feed forward into procedures in a larger planned pilot stepped wedge feasibility trial.
This study only has one arm, the intervention arm. The intervention, CKD Topics, will be administered as a quality improvement intervention.
Future Directions: This open pilot will inform procedural changes in an upcoming pilot stepped wedge feasibility trial.
This study only has one arm, the intervention arm. The intervention, CKD Topics, will be administered as a quality improvement intervention.
Future Directions: This open pilot will inform procedural changes in an upcoming pilot stepped wedge feasibility trial.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K01DK139400 | NIH | None | https://reporter.nih.gov/quic… | View |