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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

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 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

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

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,621 Previous Clinical Trials
2,290,850 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,763 Total Patients Enrolled
Shena Gazaway, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
64 Total Patients Enrolled
~85 spots leftby Jul 2027
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