Lay-Navigator Support for Kidney Disease
(ImPart-Multi Trial)
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.12345Why 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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive decision-support training sessions via telehealth or audio connection
Follow-up
Participants are monitored for safety and effectiveness after intervention
Wait-listed Control
Participants in the control group receive no training sessions initially, then complete training after 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?
4
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Citations
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