Lay-Navigator Support for Kidney Disease

(ImPart-Multi Trial)

Overseen By Shena Gazaway

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Hospice, Dialysis, Severe mental illness, others

Compensation: Varies

Number of Visits: 2

22 Participants Needed

Trial Summary

What is the purpose of this trial?

We seek to explore the feasibility and acceptability of participation in a decision-support training program led by lay navigators. ImPart-Multi, an education-telehealth-based, is designed to empower Black chronic kidney disease patients (CKD) patients and their care partner to seek the resources and support needed to be activated allies when making health-related decisions. Participants, based on random assignment, will participate in survey completion at study start and at 12 and 24 weeks of enrollment, and will complete 1, 3, or 4 education sessions via telehealth or audio connection. Participants will also complete an interview to share their thoughts on the program and other factors of interest.

Research Team

Shena Gazaway, PhD

Principal Investigator

UAB School of Nursing

Eligibility Criteria

This trial is for Black individuals with stage 3 or 4 chronic kidney disease and concurrent cardiometabolic conditions like hypertension/diabetes. Participants must speak/read English, have a care partner (18+ years old) who helps with medical decisions, and not be on dialysis or hospice care. Care partners can't have untreated severe mental illness, dementia, suicidal thoughts, hearing loss, or substance abuse.

Inclusion Criteria

Patients must have a care partner enrolled in the study - the team will assist any patient in identifying a care partner, if interested

Ability to speak and read English and complete baseline questionnaires

Care partners must have an enrolled patient

Exclusion Criteria

Medical record documentation of active unmedicated severe mental illness, moderate-severe dementia, suicidal ideation, uncorrected hearing loss, and active substance abuse

I am currently on dialysis.

Care partners have mental illness, severe memory loss, thoughts of harming themselves, hearing problems, or are currently using drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive decision-support training sessions via telehealth or audio connection

12 weeks

1-4 sessions (telehealth or audio)

Follow-up

Participants are monitored for safety and effectiveness after intervention

12 weeks

1 follow-up call

Wait-listed Control

Participants in the control group receive no training sessions initially, then complete training after 12 weeks

12 weeks

Treatment Details

Interventions

• ImPart-Multi

Trial Overview The ImPart-Multi program is being tested to see if it's feasible and acceptable. It involves education sessions via telehealth to help patients and their care partners make better health-related decisions. The study measures the effectiveness through surveys at the start of the study and after 12 and 24 weeks.

Participant Groups

Group I: Group 3 - Communication and Social Support Effectiveness Experimental Treatment 1 Intervention

Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed.

Group II: Group 2 - Social Support Effectiveness Experimental Treatment 1 Intervention

Participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed.

Group III: Group 1 - Communication Experimental Treatment 1 Intervention

Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed.

Group IV: Group 4 - Wait-listed Control Placebo Group 1 Intervention

Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+