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Behavioural Intervention

ImPart for Chronic Kidney Disease (ImPart Trial)

N/A

Recruiting

Led By Shena Gazaway, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18;

Patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after baseline

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new method called Multiphase Optimization Strategy (MOST) to help improve the decision-making skills of people with stage 4 chronic kidney disease and their caregivers. The study will

Who is the study for?

This trial is for pairs of patients with stage 4 chronic kidney disease and their caregivers. Participants must be adults, able to speak and read English, and complete questionnaires. Each patient needs a confirmed diagnosis (with specific test results) and an enrolled caregiver willing to join the study.

What is being tested?

The IMPART study tests how well different training programs help patients with chronic kidney disease and their caregivers make decisions together. It uses a special design where dyads get varying amounts of coaching on decision support, communication training, or social support psychoeducation.

What are the potential side effects?

Since this intervention involves educational components rather than medical treatments, traditional physical side effects are not expected. However, participants may experience emotional or psychological responses to the training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention Measure

Acceptability of Intervention and Study Procedures

Feasibility of Data Collection

+3 more

Secondary study objectives

Caregiver wellbeing/quality of life as measured by the PROMIS Global Health 10

Health-related decision process for patient as measured by the Decision Conflict Scale

Health-related decision process for patient as measured by the Social Support Effectiveness- Questionnaire

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Basic social support + patient psychoeducationExperimental Treatment1 Intervention

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.

Group II: Basic social support + communication + patient psychoeducationExperimental Treatment1 Intervention

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.

Group III: Basic social support + communicationExperimental Treatment1 Intervention

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

Group IV: Basic social supportExperimental Treatment1 Intervention

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

Group V: Advanced social support + patient psychoeducationExperimental Treatment1 Intervention

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.

Group VI: Advanced social support + communication+ patient psychoeducationExperimental Treatment1 Intervention

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.

Group VII: Advanced social support + communicationExperimental Treatment1 Intervention

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

Group VIII: Advanced social supportExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met