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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Chronic Kidney Disease Structured Agenda-Setting Tool
Other interventionChronic 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.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Arm 1 is Usual CareNo intervention 0 interventions
Group B: Arm 2 is Clinical Visit Agenda Setting Tool InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Feasibility Outcome
The primary outcome will be feasibility, assessed by the proportion of patients who received the intervention.
Time frame
From enrollment to the end of treatment at 16 monthsSecondary outcomes
1
Secondary Feasibility Outcome
The secondary outcome will be feasibility assessed by the clinicians' intention to continue the intervention use, measured in a survey.
Time frame
From enrollment to the end of treatment at 16 monthsOther outcomes
1
Primary Process Outcome: Enrollment Rate
As measured by participant enrollment in Redcap.
Time frame
From enrollment to the end of treatment at 16 months2
Secondary Process Outcome: Loss to follow-up
As measured by participant dropout (loss to follow-up) in Redcap.
Time frame
From enrollment to the end of treatment at 16 months3
Preliminary Efficacy Outcome: Patient Self-Advocacy Scale (PSAS)
The Patient Self-Advocacy Scale (PSAS); a 12-item validated scale assessing the latent construct of perceived self-advocacy for patients.
Time frame
From enrollment to the end of treatment at 16 months4
Preliminary Efficacy Outcome: Patient self-efficacy
Patient self-efficacy measured using the Ask, Understand, Remember Assessment, (AURA); a validated 4-item assessment of self-efficacy completed by patients.
Time frame
From enrollment to the end of treatment at 16 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
Dartmouth College
Collaborator
University of Washington
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: