Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)

NCT06067009 | Completed Results DMC

• 2 other identifiers: 300011311UAB
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to explore the feasibility and acceptability of participation in a decision-support training program led by lay navigators. ImPart-Multi, an education-telehealth-based program, is designed to empower Black chronic kidney disease patients (CKD) and their care partners to seek the resources and support needed to be activated allies when making health-related decisions. Participants, both caregivers and patients, completed surveys at study start and at 12 weeks of enrollment. Patients only, based on random assignment, then completed either 1, 3, or 4 education sessions via telehealth or audio connection. Caregivers were not restricted from attending sessions, but were not required. Both patients and caregivers then repeated survey measures at 12 weeks of enrollment. Caregiver and patient participants also completed an interview to share their thoughts on the version of the program they recieved (patients) caregiver interviews focused on if they were able to review mateirals send to the patient, and/or if they noticed a difference in communication, information sharing, etc. after the patient compelted their session(s), and other factors of interest.

Conditions

Cardiometabolic Risk Factors; Kidney Diseases

Keywords

decision support; decision-making; patient activation; caregiving

Outcome Measures

Primary Outcomes (2)

• Acceptability Interviews (Investigator Developed)

  Through qualitative interviews, participants reported if ImPart-Mulit participation and trial procedures were acceptable.

  Completed at 12 week survey data collection

• Feasibility of Intervention Measure

  The FIM is a 4 question survey asking questions regarding how feasible it was to complete the ImPart-Multi Intervention on a 5 point likert scale (1-5). The closer the mean to 5 the greater preceived feasibiltiy. Only patients completed sessions, so only patient data is represented in this measures outcomes. The closer to 5 the mean, the more feasiable the intervention was precieved. All patients did not complete this measure.

  12 weeks

Secondary Outcomes (5)

• Decision Conflict Scale (DCS)

  From enrollment to end of study at 12 weeks

• Social Support Effectiveness-Questionnaire

  From enrollment to end of study at 12 weeks

• Kidney Disease Quality of Life Scale (KDQOL-36)

  From enrollment to end of study at 12 weeks

• PROMIS Global Health 10

  From enrollment to end of study at 12 weeks

• Dyadic Coping Inventory

  From enrollment to end of study at 12 weeks

Study Arms (4)

Group 1 - Communication

EXPERIMENTAL

Patient participants in this group completed one session of communication training and had 1 follow up call a month after the session has been completed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.

Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease

Group 2 - Social Support Effectiveness

EXPERIMENTAL

Patient participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.

Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease

Group 3 - Communication and Social Support Effectiveness

EXPERIMENTAL

Patient participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.

Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease

Group 4 - Wait-listed Control

PLACEBO COMPARATOR

Patient participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. After 12 week data collection, the patient will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made.

Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease

Interventions

ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease BEHAVIORAL

ImPart-Multi is a psychoeducational, decision support training program, designed to impact Black chronic kidney disease patients with concurrent metabolic disease and their care partners' ability to 1. contemplate the decision needed, 2. request resources/support, and 3. make an informed patient-centered decision. Participants will participate in either communication training, social support effectiveness training, or a combination of both.

Group 1 - Communication; Group 2 - Social Support Effectiveness; Group 3 - Communication and Social Support Effectiveness; Group 4 - Wait-listed Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients
• Electronic medical record (EMR) documented diagnosis of stage 3 or 4 CKD (2 estimated glomerular filtration rate \[eGFR\] between 45-15 within 90 days); and concurrent cardiometabolic disease (hypertension and/or diabetes)
• Ability to speak and read English and complete baseline questionnaires;
• Patients must have a care partner enrolled in the study - the team will assist any patient in identifying a care partner, if interested.
• Care partner
• 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";
• Ability to speak and read English and complete baseline questionnaires;
• Care partners must have an enrolled patient.

You may not qualify if:

• Patients
• Receiving hospice;
• Receiving dialysis;
• Medical record documentation of active unmedicated severe mental illness, moderate-severe dementia, suicidal ideation, uncorrected hearing loss, and active substance abuse.
• Care partner 1. Self-reported unmedicated mental illness, mild-severe dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse ascertained by study introduction questioning.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0001, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Patient Participation

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

1. Small sample size 2. Data collection is limited to a single site 3. Limited generalizabitly as focus was on adult Black individuals

Results Point of Contact

• Title: Shena Gazaway
• Organization: University of Alabama at Birmingham

gazaways@uab.edu

2059755304

Study Officials

• Shena Gazaway, PhD

  UAB School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: March 20, 2024
• Primary Completion: February 10, 2025
• Study Completion: February 25, 2025
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)