Improving Decision-Making for Chronic Kidney Disease Patients and Caregivers
This study is testing a program called ImPart, which aims to help people with stage 4 chronic kidney disease (CKD) and their caregivers make better decisions together about their health. ImPart is a behavioral intervention, meaning it focuses on skills and communication. The study wants to see if ImPart is acceptable, appropriate, and practical to use. You might be able to join if you are at least 18 years old, have stage 4 CKD (eGFR between 29-15), can speak and read English, and have a caregiver who can also participate. The study is looking for 128 participants in total.
- Study design
- This interventional study plans to enroll 128 participants, including patients with chronic kidney disease and their caregivers. It uses a 2x2x2 full factorial design to test different components of the ImPart program.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 12 weeks after baseline.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
At a glance
Conditions
NCT06173323
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Shena Gazaway
Birmingham, Alabamastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Shena Gazaway, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
Who to contact
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Inclusion
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What this trial measures
- Acceptability of Intervention Measure12 weeks
four-item measure of implementation outcomes that are often considered "leading indicators" of implementation success; higher score indicate greater acceptability (highest score - 20)
- Intervention Appropriateness Measure12 weeks
Four-item measure of implementation outcomes that are often considered "leading indicators" of implementation success; higher score indicate greater appropriateness (highest score - 20)
- Feasibility of Intervention12 weeks after baseline
Intervention completion rate (# participants completing assigned components) will be tabulated, ≥75% completion rates for assigned components will be considered evidence of feasibility
- Feasibility of Data Collectionbaseline, 12 weeks, 24 weeks after baseline
Intervention assessment completion rate (# participants completing each study assessment) will be tabulated, ≥75% completion rates for study assessments will be considered evidence of feasibility
- Feasibility of Intervention Process12 weeks
Feasibility of Intervention Measure a four-item measure of implementation - higher scores = greater feasibility (highest score - 20)
- Acceptability of Intervention and Study Procedures24 weeks
Determined by thematic analysis, of digitally recorded, semi-structured qualitative interviews adapted from prior study teams' work. Open-ended questions will query participants about their experiences with their assigned intervention components, the navigator, study procedures, how program impacted their engagement in shared decision-making and changes they would like to see made to the intervention and study procedures.