Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06173323

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

184 weeks

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

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).

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Documented diagnosis of stage 4 CKD with 2 eGFR values between 15 and 29 within 90 days
  • Ability to speak and read English and complete baseline questionnaires
  • Patients 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 CKD
  • Ability of caregivers to speak and read English and complete baseline questionnaires
  • Caregivers must have an enrolled patient
Not Eligible

You will not qualify if you...

  • Patients receiving hospice care
  • Patients receiving dialysis treatment
  • 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 determined by study questioning

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

A

Alicia Cole, MS

CONTACT

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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