NCT06173323 · University of Alabama at Birmingham
A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
(ImPart)
What this study is about
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.
View original scientific description
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).
Interventions
BEHAVIORAL
ImPart - Improving Chronic Kidney Disease Decisional Partnerships
ImPart is a decision support intervention developed and refined in partnership with a advisory group of patients with and caregivers of people living with Chronic Kidney Disease. The program is designed to support decision-making throughout the illness experience.
Primary outcome measures
Acceptability of Intervention Measure
Time frame: 12 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 Measure
Time frame: 12 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 Intervention
Time frame: 12 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 Collection
Time frame: baseline, 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 Process
Time frame: 12 weeks
Feasibility of Intervention Measure a four-item measure of implementation - higher scores = greater feasibility (highest score - 20)
Acceptability of Intervention and Study Procedures
Time frame: 24 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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:
- 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
- Birmingham, Alabama
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 26, 2026 · Source of record for eligibility and locations