NCT06173323Recruiting
A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
An Optimization Trial of a Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, an optimization trial approach to develop and refine the decision partnering skills of persons with stage 4 chronic kidney disease and their caregivers. Using a 2x2x2 full factorial design, 64 dyads (patients and one identified caregiver) will be randomized to receive one or more lay coach-delivered decision partnering training components, based on Pearlin's Stress-Health Model of Family Caregiving and Rini's Social Support Effectiveness theory. The components include: 1) caregiver coaching on effective decision support (1 vs. 3 sessions); 2) caregiver decision support communication training (1 session vs. none); and 3) patient social support effectiveness psychoeducation (yes vs. no).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 7 Dec 2023
- Start date
- 16 Sept 2024
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Chronic kidney disease
- NCT number
- NCT06173323
What you commit to
- Study type: Interventional
- Planned participants: 128
- From 16 Sept 2024 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Caregivers 1) Self-reported unmedicated mental illness, Moderate-severe dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse ascertained by scripted study introduction questioning.
Who the study is looking for
- Patients
- Age ≥18;
- EMR documented diagnosis of stage 4 CKD (2 eGFR 29-15 within 90 days);
- Ability to speak and read English and complete baseline questionnaires;
- Patients must have an enrolled caregiver
- Caregivers
- Age ≥18;
- 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
- Caring for a patient with CKD;
- Ability to speak and read English and complete baseline questionnaires;
- Caregivers must have an enrolled patient.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shena Gazaway Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
Related publications
- Decision support training for chronic kidney disease dyads: the ImPart Study protocol.Pilot Feasibility Stud · 2025 · PMID 41449447
This page is information, not medical advice. Discuss any trial with your doctor.