RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-09-16
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06173323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients
  2. 1. Age ≥18;
  3. 2. EMR documented diagnosis of stage 4 CKD (2 eGFR 29-15 within 90 days);
  4. 3. Ability to speak and read English and complete baseline questionnaires;
  5. 4. Patients must have an enrolled caregiver
  1. * Patients
  2. 1. Receiving hospice;
  3. 2. Receiving dialysis;
  4. 3. Medical record documentation of active unmedicated severe mental illness, moderate-severe dementia, suicidal ideation, uncorrected hearing loss, and active substance abuse.

Contacts and Locations

Study Contact

Shena Gazaway, Phd, RN
CONTACT
205-975-5704
gazaways@uab.edu
Alicia Cole, MS
CONTACT
205-934-2862
acole569@uab.edu

Principal Investigator

Shena Gazaway, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

Shena Gazaway
Birmingham, Alabama, 35294-1150
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Shena Gazaway, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16
Study Completion Date2028-01

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • chronic kidney disease
  • shared decision making
  • family caregiving

Additional Relevant MeSH Terms

  • Decision Making, Shared
  • Family Caregiving
  • Chronic Kidney Disease