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A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)

RecruitingNAAges 18 Years - anyAllUniversity of Alabama at Birmingham
NCT06173323 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • ImPart - Improving Chronic Kidney Disease Decisional Partnerships
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Where

1 site
Shena Gazaway
Birmingham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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