The Agenda-Setting for Kidney Disease Trial

Conditions

• Chronic Kidney Disease Stage 4
• Chronic Kidney Disease Stage 5

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Chronic Kidney Disease Structured Agenda-Setting Tool — OTHER
  Chronic Kidney Disease (CKD) Topics is a novel clinical visit agenda-setting intervention developed through participatory research methods for people with CKD living in rural areas. CKD Topics includes structured discussion topic areas.

Study Details

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

Key Dates

Start date

Sep 1, 2026

Status verified

Jun 2025

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

108 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• No Intervention: Arm 1 is Usual Care
  The clinicians in the nephrology clinic will proceed with usual care without intervention from the study team.
• Experimental: Arm 2 is Clinical Visit Agenda Setting Tool Intervention
  The study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for advanced chronic kidney disease, called Chronic Kidney Disease (CKD) Topics.

Primary Outcome Measure

Primary Feasibility Outcome [ Time Frame: From enrollment to the end of treatment at 16 months ]

Central Contacts

• Catherine H. Saunders, Assistant Professor of Medicine and of Health Policy, PhD, MPH
  603-653-3436
  [email protected]
• Anne E. Dade, Research Associate, MPP
  [email protected]

Locations (1)

Find similar trials in Lebanon, NH

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