Decision support training for chronic kidney disease dyads: the ImPart Study protocol.
Shena Gazaway, Rachel Wells, Orlando M Gutierrez...
https://pubmed.ncbi.nlm.nih.gov/41449447Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06173323
An Optimization Trial of a Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
Led by University of Alabama at Birmingham · Updated on 2026-01-26
128
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to develop and refine decision partnering skills between patients with stage 4 chronic kidney disease (CKD) and their caregivers. It focuses on improving how these dyads make health-related decisions throughout the illness, addressing gaps in current interventions that often exclude caregivers and overlook broader decision-making beyond specific medical treatments. The study uses the Multiphase Optimization Strategy (MOST) to test different training components efficiently. Participants are randomized into one of eight groups receiving various combinations of caregiver coaching sessions, caregiver communication training, and patient psychoeducation. The intervention is delivered via telehealth and includes weekly sessions and monthly follow-up calls to support decision-making partnerships. Components tested include differing numbers of coaching sessions and the presence or absence of communication and psychoeducation training. Participants and their caregivers engage in assessments at baseline, 12 weeks, and 24 weeks to evaluate the feasibility, acceptability, and preliminary impact of the intervention components. Measures include decision conflict, social support effectiveness, distress, quality of life, and dyadic coping. The study lasts 24 weeks, with close monitoring of intervention completion and data collection processes to inform future trials.
CONDITIONS
Brief Title
A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Documented diagnosis of stage 4 chronic kidney disease with two eGFR values between 15 and 29 ml/min within 90 days
- Ability to speak and read English and complete baseline questionnaires
- Must have an enrolled caregiver
- Caregivers aged 18 years or older
- Caregivers identified by the patient as a relative, friend, or partner who assists with medical decisions and is unpaid
- Caregivers caring for a patient with chronic kidney disease
- Caregivers able to speak and read English and complete baseline questionnaires
- Caregivers must have an enrolled patient
You will not qualify if you...
- Patients receiving hospice care
- Patients receiving dialysis
- Patients with active unmedicated severe mental illness, moderate to severe dementia, suicidal ideation, uncorrected hearing loss, or active substance abuse
- Caregivers with self-reported unmedicated mental illness, moderate to severe dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse as assessed by study questioning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or telephone)
Outpatient Treatment
Duration - Up to 4 weeks depending on intervention components assigned
Participants receive behavioral intervention sessions designed to improve decision-making partnerships between patients with stage 4 Chronic Kidney Disease and their caregivers via telehealth or telephone. Sessions include social support, communication training, and psychoeducation.
1 to 4 weekly sessions (in-person or telephone), plus monthly follow-up calls for up to 24 weeks
Follow-up
Duration - Up to 24 weeks after intervention start
Participants complete follow-up assessments to evaluate intervention feasibility, acceptability, and preliminary efficacy over 24 weeks.
Assessments at baseline, 12 weeks, and 24 weeks (in-person or telephone)
Trial Site Locations
Total: 1 location
1
Shena Gazaway
Birmingham, Alabama, United States, 35294-1150
Actively Recruiting
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Research Team
S
Shena Gazaway, Phd, RN
A
Alicia Cole, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
8
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