Improving decision-making for chronic kidney disease patients and their caregivers
An Optimization Trial of a Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
This study is testing a program to help patients with stage 4 chronic kidney disease and their caregivers make better health decisions together.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06173323 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the decision-making skills of patients with stage 4 chronic kidney disease (CKD) and their caregivers through a structured intervention. Utilizing a Multiphase Optimization Strategy (MOST), 64 dyads will be randomized to receive various components of decision partnering training, which includes caregiver coaching and communication training. The goal is to empower both patients and caregivers to navigate health-related decisions more effectively, particularly in the context of CKD management and end-of-life choices. The intervention is designed to address the unique challenges faced by historically excluded populations, particularly Black CKD patients and their families.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a documented diagnosis of stage 4 chronic kidney disease who have an enrolled caregiver.
Not a fit: Patients receiving hospice care, dialysis, or those with severe mental illness or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the decision-making process and overall well-being of CKD patients and their caregivers.
How similar studies have performed: While there have been few interventions focusing on decision-making in CKD that include caregivers, this approach is innovative and aims to fill a significant gap in existing research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama
- Shena Gazaway — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Shena Gazaway, PhD — University of Alabama at Birmingham
- Study coordinator: Shena Gazaway, Phd, RN
- Email: gazaways@uab.edu
- Phone: 205-975-5704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.