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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a decision-support training program led by lay navigators for Black patients with chronic kidney disease (CKD) and a heart-related condition such as high blood pressure or diabetes. The program, called ImPart-Multi, seeks to empower patients and their care partners to make better health decisions together. Participants will be randomly assigned to different groups to test communication and social support training through telehealth sessions. Individuals with stage 3 or 4 CKD who have a care partner and can speak and read English may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance decision-making support for patients and their care partners.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on education and support, so it's unlikely that medication changes are required, but you should confirm with the trial organizers.

What prior data suggests that this decision-support training program is safe for participants?

Research shows that treatments in this trial, such as Social Support Effectiveness and Communication Training, are generally safe. Although specific safety data for these treatments in chronic kidney disease studies is lacking, similar educational and social support methods have been widely used without major safety concerns.

Other studies have found these types of programs well-received, with participants usually experiencing little to no negative effects. Designed to enhance decision-making and communication skills, these educational and support programs are non-invasive and low-risk, as they don't involve medications.

These interventions aim to improve skills and support systems rather than directly change physical health, making them a safe choice for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support kidney disease patients through communication and social support training. Unlike standard treatments that focus primarily on medical management, this trial examines how structured training sessions can potentially improve patient outcomes by enhancing their communication skills and support networks. By testing different combinations of training, the trial aims to identify the most effective method for boosting patient engagement and well-being, potentially leading to better health outcomes and quality of life for those with kidney disease.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

This trial will evaluate different training methods for patients with chronic kidney disease (CKD). Participants in Group 2 will receive social support effectiveness training, which research has shown can help patients make medical decisions that align with their personal preferences, potentially reducing unexpected dialysis. Group 1 will focus on communication training, which benefits patients by increasing their confidence in managing CKD. Group 3 will combine both communication and social support effectiveness training, equipping patients with better tools to handle their condition and improve their quality of life. Overall, these methods aim to empower patients, making them active participants in their healthcare decisions. ^{1 2 6 7 8}

Who Is on the Research Team?

Shena Gazaway, PhD

Principal Investigator

UAB School of Nursing

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06173323

A Stakeholder-enhanced Intervention to Improve the ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes.

2. withpower.com withpower.com/trial/phase-chronic-kidney-disease-ckd-2-2024-98890

ImPart for Chronic Kidney Disease Trial Overview The IMPART study tests how well different training programs help patients with chronic kidney disease and their caregivers make decisions ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06799936

A Communication-Priming Intervention to Improve Shared ... This study aims to conduct a cluster-randomized controlled trial to assess the effects of the 'CKD Jumpstart- Tips' communication-priming intervention on shared ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12054969/

Impact of the Kidney Score Platform on Communication ... The primary outcome was the change in self-efficacy for CKD management, ascertained by the Patient Activation Measure [19] after the participant ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949813923001258

Shared Decision-Making and Patient Communication in ... This paper will address SDM in nephrology practice, reviewing underlying supportive evidence, context, and timing for employing SDM in the trajectory of chronic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10734071/

Shared decision making in chronic kidney disease This study calls for linguistic-informed contextualised communication training and provides foundational evidence for nephrology-specific ...

7. formative.jmir.org formative.jmir.org/2025/1/e56855

Impact of the Kidney Score Platform on Communication About ... The impact of the Kidney Score on the Patient Activation Measure (the primary outcome), knowledge about CKD, and communication with their ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9125352/

Effectiveness of end-stage renal disease communication ... This single-center, single-blind, randomized study employing repeated measures tested the online ESRD CST. The outcomes were the truth-telling ...