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A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)

An Optimization Trial of a Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)

Who can join

Ages 18 and older · All sexes

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.

About the study

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).

What is being tested

• ImPart - Improving Chronic Kidney Disease Decisional Partnerships (behavioral)

Sponsor: University of Alabama at Birmingham · Participants: 128 · Started: Sep 16, 2024

Contact the study team

• Shena Gazaway, Phd, RN · Phone: 205-975-5704
• Alicia Cole, MS · Phone: 205-934-2862

Official record on ClinicalTrials.gov — NCT06173323

Locations in the U.S.

Conditions

• Chronic Kidney Disease

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.