Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)

Completed · Not applicable

Conditions studied: Kidney Diseases, Cardiometabolic Risk Factors

In brief

The purpose is to explore the feasibility and acceptability of participation in a decision-support training program led by lay navigators. ImPart-Multi, an education-telehealth-based program, is designed to empower Black chronic kidney disease patients (CKD) and their care partners to seek the resources and support needed to be activated allies when making health-related decisions. Participants, both caregivers and patients, completed surveys at study start and at 12 weeks of enrollment. Patients only, based on random assignment, then completed either 1, 3, or 4 education sessions via telehealth or audio connection. Caregivers were not restricted from attending sessions, but were not required. Both patients and caregivers then repeated survey measures at 12 weeks of enrollment. Caregiver and patient participants also completed an interview to share their thoughts on the version of the program they recieved (patients) caregiver interviews focused on if they were able to review mateirals send to the patient, and/or if they noticed a difference in communication, information sharing, etc. after the patient compelted their session(s), and other factors of interest.

Key facts

Study ID

NCT06067009

Run by

University of Alabama at Birmingham

People needed

22

Starts

2024-03-20

Expected to finish

2025-02-25

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients
• Electronic medical record (EMR) documented diagnosis of stage 3 or 4 CKD (2 estimated glomerular filtration rate [eGFR] between 45-15 within 90 days); and concurrent cardiometabolic disease (hypertension and/or diabetes)
• Ability to speak and read English and complete baseline questionnaires;
• Patients must have a care partner enrolled in the study - the team will assist any patient in identifying a care partner, if interested.
• Inclusion Criteria:
• Care partner
• Age ≥18; 2) Self-endorsing or identified by the patient as "a relative, friend, or partner that has a close relationship with you and who assists you with your medical decisions and who may or may not live in the same residence as you and who is not paid for their help";
• Ability to speak and read English and complete baseline questionnaires;
• Care partners must have an enrolled patient.

You may not qualify if…

• Patients
• Receiving hospice;
• Receiving dialysis;
• Medical record documentation of active unmedicated severe mental illness, moderate-severe dementia, suicidal ideation, uncorrected hearing loss, and active substance abuse.
• Exclusion Criteria:
• Care partner 1. Self-reported unmedicated mental illness, mild-severe dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse ascertained by study introduction questioning.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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