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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06173323
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ImPart - Improving Chronic Kidney Disease Decisional Partnerships — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Sep 16, 2024
Status verified
Dec 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE

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

Primary Outcome Measure

Acceptability of Intervention Measure [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shena GazawayBirminghamAlabama35294-1150
Shena Gazaway
[email protected]
2059755304

Find similar trials in Birmingham, AL

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Shena Gazaway· Birmingham, AL

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