The Agenda-Setting for Kidney Disease Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center

About this trial

The goal of this clinical trial is to learn if a tool with a list of discussion topics, called a structured clinical visit agenda-setting intervention (SAS), works for people with advanced chronic kidney disease (CKD) who receive care at a clinic that serves people who live in rural areas. The SAS is called CKD Topics. The researchers will compare the SAS intervention to usual care (the way clinicians usually practice) to see how well it works for people with advanced CKD. This is a special type of clinical trial called a stepped wedge randomized clinical trial (RCT). In this type of trial, every participant will get to experience both usual care and CKD Topics, but for different amounts of time.

The researchers will learn if doing a clinical trial of CKD Topics is possible (feasible) and get information about how well CKD Topics helps people with advanced CKD shape visit discussions (self-advocacy) in their appointments with their clinicians. The information the researchers collect in this trial will help design a future trial with more participants.

The main questions the researchers aim to answer are:

* Is it possible to conduct this type of study of a SAS intervention? i.e. feasibility * Does the SAS intervention help people with advanced CKD shape discussions (self-advocacy) with their clinicians? If so, how much? i.e. preliminary efficacy

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Chronic Kidney Disease Structured Agenda-Setting Tool

Treatment groups

108 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dartmouth-Hitchcock Medical Center

Lead sponsor

Dartmouth College

Collaborator

University of Washington

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator