CKD Awareness, Referrals, Education, and Support Intervention for Early-Stage CKD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
The goal of this pilot clinical trial is to learn if an intervention delivering education, motivational support, and social support can prevent worsening kidney disease in adults with diabetes and early-stage kidney disease. The main questions it aims to answer are:
1. Is this intervention feasible to deliver and acceptable to patients? 2. What is the impact of the intervention on patient motivation, self-efficacy, kidney disease knowledge, and use of support services referrals?
The investigators will compare information collected about participants' response to this intervention with a group of similar patients who receive general diabetes information.
Participants will meet virtually with a nurse approximately 1 week before a scheduled primary care provider visit and complete surveys over the phone three times in a period of three months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults (18+)
diabetes diagnosis (type 1 or 2)
CKD Stage 3 diagnosis eligible
>1 prior visit at the UIHealth primary care clinics
Disqualifiers
CKD of congenital or pediatric onset
history of kidney transplant
cognitive impairment as documented in the medical record
Trial design
Design model
Parallel
Treatments tested in this trial
CKD Awareness, Referrals, Education, and Support (CARES)
BehavioralWe will target diabetic patients eligible for an early-stage CKD diagnosis with a nurse-delivered, pre-PCP-visit 1:1 virtual session including 1) tailored, evidence-based CKD education 2) motivational interviewing with self-management goal setting, and 3) social determinants of health screening with referrals to services as needed.
Attention control
BehavioralThe control group will receive an attention control session of general education about diabetes-related health behaviors (e.g., diet and physical activity) that does not refer to CKD, based on American Diabetes Association materials.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Motivation for diabetes-related self-care behaviour scale
Participant self-report. A scale from 1-5, with a lower score meaning not motivated and a higher score meaning highly motivated. Items are different self-management behaviors (e.g., medication, diet, exercise).
Time frame
From enrollment to study completion (2-3 months)2
Kidney Disease Knowledge Survey
Participant self-report. A set of fact-based questions about kidney disease which has a right and a wrong answer. Participants will be scored based on % correct answers.
Time frame
From enrollment to study completion (2-3 months)3
CKD Self Efficacy Instrument
Participant self-report. The scale ranges from 1-10, with low scores indicating not at all confident and high scores indicating totally confident.
Time frame
From enrollment to study completion (2-3 months)4
Social referral uptake
Participant self-report of uptake of any support services for barriers to treatment adherence that are needed.
Time frame
From enrollment to study completion (2-3 months)Secondary outcomes
1
Brief Illness Perceptions Questionnaire
Participant self-report. Scale from 1-10, with the meaning of numbers changing per item. Assessing participants' perspective and understanding of their chronic condition. Items assessed individually or using clustering approaches.
Time frame
From enrollment to study completion (2-3 months)2
Patient activation Measure
Participant self-report. Scales are 1-4 with a not applicable option, lower scores meaning less activated and engaged in care and higher scores meaning more activated and engaged in care.
Time frame
From enrollment to study completion (2-3 months)3
PROMIS Medication Adherence Scale
Participant self-report. Scale from 1-5 indicating agree to disagree, with items about performance of medication adherence behaviors.
Time frame
From enrollment to study completion (2-3 months)4
Dialysis Diet and Fluid Non-adherence Questionnaire
Participant self-report. One item asking how many days in the last week guidelines were not followed, and another item asking to what degree they were not followed, from completely to not at all.
Time frame
From enrollment to study completion (2-3 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Chicago
Collaborator
Source ClinicalTrials.gov