Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT06173323

Conditions

Decision Making, Shared

Family Caregiving

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ImPart - Improving Chronic Kidney Disease Decisional Partnerships

Study Details

Brief summary:

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

Decision Making, Shared

Family Caregiving

Chronic Kidney Disease

Study ID

NCT06173323

Start date

Sep 16, 2024

Status verified date

Dec, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Basic social support + communication + patient psychoeducation

2 in-person/telephone weekly sessions on providing social support and tips for good communication for caregiver participants and 2 sessions of social support, decision aids, and tips for good communication for patient participants and a single monthly follow-up call for both participants.

experimental: Basic social support + communication

2 in-person/telephone weekly sessions on providing social support and tips for good communication for caregiver participants and a single monthly follow-up call for caregiver participant

experimental: Basic social support + patient psychoeducation

1 in-person/telephone weekly sessions on providing social support for caregiver participants and 2 sessions of social support, decision aids, and tips for good communication for patient participants and a single monthly follow-up call for both participants.

experimental: Basic social support

1 in-person/telephone weekly sessions on providing social support for caregiver participants a single monthly follow-up call for the caregiver participant.

experimental: Advanced social support + communication+ patient psychoeducation

4 in-person/telephone weekly sessions on providing social support and tips for good communication for caregiver participants and 2 sessions of social support, decision aids, and tips for good communication for patient participants and a single monthly follow-up call for both participants.

experimental: Advanced social support + communication

4 in-person/telephone weekly sessions on providing social support and tips for good communication for caregiver participants and a single monthly follow-up call for caregiver participant

experimental: Advanced social support + patient psychoeducation

3 in-person/telephone weekly sessions on providing social support for caregiver participants and 2 sessions of social support, decision aids, and tips for good communication for patient participants and a single monthly follow-up call for both participants.

experimental: Advanced social support

3 in-person/telephone weekly sessions on providing social support for caregiver participants and a single monthly follow-up call for caregiver participant

Interventions

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 measure

  • Acceptability of Intervention Measure [ Time Frame: 12 weeks ]
  • Intervention Appropriateness Measure [ Time Frame: 12 weeks ]
  • Feasibility of Intervention [ Time Frame: 12 weeks after baseline ]
  • Feasibility of Data Collection [ Time Frame: baseline, 12 weeks, 24 weeks after baseline ]
  • Feasibility of Intervention Process [ Time Frame: 12 weeks ]
  • Acceptability of Intervention and Study Procedures [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

Shena Gazaway

Recruiting

Birmingham, Alabama, United States, 35294-1150

Contacts

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jan 26, 2026

Last verified

Dec, 2025

Keywords

  • chronic kidney disease
  • shared decision making
  • family caregiving

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-01-26.