The Agenda-Setting for Kidney Disease Open Pilot Trial

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Disease Stage 4

• Registration Number: NCT07221604
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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?

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.

Study Timeline

• Study First Submitted: 2025-06-18
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-27
• Last Update Submitted: 2025-10-27
• Study First Posted: 2025-10-28
• Last Update Posted: 2025-10-28
• Study Start: 2026-07-01
• Primary Completion: 2026-08
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults >18 years old who have been diagnosed with advanced CKD (stages 4-5).
• Care partners, clinicians and staff supporting these CKD patients who are willing and able to provide informed consent
• English-speaking
• Able to provide informed consent
• Patient must be attending outpatient visits *(in-person and/or telehealth allowable).

Exclusion Criteria

• Children under 18 years old will not be included
• Non-English-speaking patients and/or care partners
• Patients on dialysis
• Individuals unable or unwilling to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Feasibility Outcome: Intervention receipt	Day 1	Our primary outcome will be feasibility, assessed by the proportion of patients who received the intervention.

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States