NCT06173323|RecruitingDMC

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

ImPart

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

University of Alabama at Birmingham ClinicalTrials.gov

Compare

2 other identifiers

3000122211K23DK134756

Study Type

interventional

Target

128

Locations

1 country

Sites

Timeline

RegisteredDec 2023

StartedSep 2024

CompletionMar 2028

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

128

participants targeted

Target at P50-P75 for not_applicable

Timeline

23mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

Study Progress46%

Sep 2024Mar 2028

First Submitted

Initial submission to the registry

December 7, 2023

Completed

8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed

9 months until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

January 26, 2026

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

December 7, 2023

Last Update Submit

January 23, 2026

Conditions

Decision Making, Shared Family Caregiving Chronic Kidney Disease

Keywords

chronic kidney diseaseshared decision makingfamily caregiving

Outcome Measures

Primary Outcomes (6)

Acceptability of Intervention Measure
four-item measure of implementation outcomes that are often considered "leading indicators" of implementation success; higher score indicate greater acceptability (highest score - 20)
12 weeks
Intervention Appropriateness Measure
Four-item measure of implementation outcomes that are often considered "leading indicators" of implementation success; higher score indicate greater appropriateness (highest score - 20)
12 weeks
Feasibility of Intervention
Intervention completion rate (# participants completing assigned components) will be tabulated, ≥75% completion rates for assigned components will be considered evidence of feasibility
12 weeks after baseline
Feasibility of Data Collection
Intervention assessment completion rate (# participants completing each study assessment) will be tabulated, ≥75% completion rates for study assessments will be considered evidence of feasibility
baseline, 12 weeks, 24 weeks after baseline
Feasibility of Intervention Process
Feasibility of Intervention Measure a four-item measure of implementation - higher scores = greater feasibility (highest score - 20)
12 weeks
Acceptability of Intervention and Study Procedures
Determined by thematic analysis, of digitally recorded, semi-structured qualitative interviews adapted from prior study teams' work. Open-ended questions will query participants about their experiences with their assigned intervention components, the navigator, study procedures, how program impacted their engagement in shared decision-making and changes they would like to see made to the intervention and study procedures.
24 weeks

Secondary Outcomes (6)

Health-related decision process for patient as measured by the Decision Conflict Scale
baseline, 12 weeks, and 24 weeks after baseline
Health-related decision process for patient as measured by the Social Support Effectiveness- Questionnaire
baseline, 12 weeks, and 24 weeks after baseline
Patient and Caregiver well-being/distress as measured by the Hospital Anxiety and Depression Scale
baseline, 12 weeks, and 24 weeks after baseline
Patient wellbeing/quality of life as measured by the Kidney Disease Quality of Life Scale (KDQOL 36)
baseline, 12 weeks, and 24 weeks after baseline
Patient and caregiver interaction as measured by the Dyadic Coping Inventory
baseline, 12 weeks, and 24 weeks after baseline
+1 more secondary outcomes

Study Arms (8)

Basic social support + communication + patient psychoeducation

EXPERIMENTAL

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.