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Lay-Navigator Support for Kidney Disease (ImPart-Multi Trial)

N/A

Recruiting

Led By Shena Gazaway, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with 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)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up groups 1, 2, 3 and 4 baseline through to 12 weeks; group 4 only baseline to 24 weeks

Awards & highlights

ImPart-Multi Trial Summary

This trial seeks to empower Black CKD patients and their care partners to make health-related decisions with support from lay navigators.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention is educational rather than medicinal, traditional side effects are not expected; however participants may experience discomfort discussing personal health issues or find the time commitment challenging.

ImPart-Multi Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have stage 3 or 4 kidney disease with heart disease and/or diabetes.

ImPart-Multi Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ groups 1, 2, 3 and 4 baseline through to 12 weeks; group 4 only baseline to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~groups 1, 2, 3 and 4 baseline through to 12 weeks; group 4 only baseline to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and groups 1, 2, 3 and 4 baseline through to 12 weeks; group 4 only baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of Intervention and Study Procedures

Feasibility of Intervention Delivery and Data Collection

Secondary outcome measures

Care partner well being using the PROMIS Global Health 10

Decision-making process using the Decision Conflict Scale (DCS)

Decision-making process using the Social Support Effectiveness-Questionnaire

+2 more

ImPart-Multi Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 3 - Communication and Social Support EffectivenessExperimental Treatment1 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 EffectivenessExperimental Treatment1 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 - CommunicationExperimental Treatment1 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 ControlPlacebo Group1 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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,598 Total Patients Enrolled

Shena Gazaway, PhDPrincipal InvestigatorUAB School of Nursing

1 Previous Clinical Trials

128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are current enrollees being accepted into this research study?

"According to clinicaltrials.gov, there are no current openings for this study which was posted on November 15th 2023 and last updated on September 27th 2023. However, 512 other trials seeking volunteers remain available in the present moment."

Answered by AI

What is the aim of this investigation?

"This clinical trial will assess the practicality of data collection and delivery of intervention via three groups over a 12-week period (Group 4 for 24 weeks). Secondary outcomes include an evaluation on help received in the last 3 months, physical health, mental wellbeing, and kidney disease quality of life. Additionally, care partner well being is measured using PROMIS Global Health 10 which gauges global health-related quality of life with two domains: physical and mental health."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Shena Gazaway 2024. "Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067009.