NCT06173323 A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
| NCT ID | NCT06173323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Decision Making, Shared |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2024-09-16 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Patients 1. Age ≥18; 2. EMR documented diagnosis of stage 4 CKD (2 eGFR 29-15 within 90 days); 3. Ability to speak and read English and complete baseline questionnaires; 4. Patients must have an enrolled caregiver Exclusion Criteria: * Patients 1. Receiving hospice; 2. Receiving dialysis; 3. Medical record documentation of active unmedicated severe mental illness, moderate-severe dementia, suicidal ideation, uncorrected hearing loss, and active substance abuse. Inclusion Criteria: * Caregivers 1. 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 3. Caring for a patient with CKD; 4. Ability to speak and read English and complete baseline questionnaires; 5. Caregivers must have an enrolled patient. Exclusion Criteria: * 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.
Contact & Investigator
Shena Gazaway, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06173323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Decision Making, Shared. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06173323 currently recruiting?
Yes, NCT06173323 is actively recruiting participants. Contact the research team at gazaways@uab.edu for enrollment information.
Where is the NCT06173323 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06173323 clinical trial?
NCT06173323 is sponsored by University of Alabama at Birmingham. The principal investigator is Shena Gazaway, PhD at University of Alabama at Birmingham. The trial plans to enroll 128 participants.