A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
Recruiting now · Not applicable
Conditions studied: Decision Making, Shared, Family Caregiving, Chronic Kidney Disease
In brief
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).
Key facts
- Study ID
- NCT06173323
- Run by
- University of Alabama at Birmingham
- People needed
- 128
- Starts
- 2024-09-16
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
- Inclusion Criteria:
- 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.
- 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.
Where it is running
- Shena Gazaway — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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