The Agenda-Setting for Kidney Disease Open Pilot Trial
ConditionChronic Kidney Disease Stage 4
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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?
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
Single group
Treatments tested in this trial
Chronic Kidney Disease Structured Agenda-Setting Tool
BehavioralChronic 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 8 structured discussion topic areas with the option for patients to consider and indicate their priority topic areas and take notes before, during, and after a clinical visit.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Arm 1 is Clinical Visit Agenda Setting Tool InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Feasibility Outcome: Intervention receipt
Our primary outcome will be feasibility, assessed by the proportion of patients who received the intervention.
Time frame
Day 1Other outcomes
1
Primary Process Outcome: Enrollment Rate
As measured by participant enrollment in Redcap.
Time frame
Day 12
Preliminary Efficacy Outcome: Patient Self-Advocacy Scale (PSAS)
Patient Self-Advocacy Scale (PSAS); a 12-item validated scale assessing the latent construct of perceived self-advocacy for patients.
Time frame
Day 13
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
Day 14
Preliminary Efficacy Outcome: Patient self-management
Patient demonstration of self-management using the Perceived Medical Condition Self-Management Scale; an 8-item instrument validated to assess self-management among CKD patients; correlated with treatment adherence.
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Dartmouth College
Collaborator
Source ClinicalTrials.gov