N/A
Completed N=22
Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)
Source: ClinicalTrials.gov NCT06067009 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Acceptability Interviews (Investigator Developed) — 3; 2; 2; 2 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability Interviews (Investigator Developed) |
3; 2; 2; 2; 6; 2 | — |
| PRIMARY Feasibility of Intervention Measure |
1.67; 3; 4; 3 | — |
| SECONDARY Decision Conflict Scale (DCS) |
22.40; 28.13; 30.47; 24.22; 16.15; 25.01 | — |
| SECONDARY Social Support Effectiveness-Questionnaire |
68.00; 59.97; 62.00; 61.18; 76.00; 46.5 | — |
| SECONDARY Kidney Disease Quality of Life Scale (KDQOL-36) |
95.45; 62.88; 78.85; 75.00; 100; 71.59 | — |
| SECONDARY PROMIS Global Health 10 |
34.87; 38.20; 31.57; 46.56; 38.20; 36.10 | — |
| SECONDARY Dyadic Coping Inventory |
137.1667; 133.00; 116.50; 83.25; 138.67; 112.75 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06067009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.