NCT05003115

Brief Summary

This study addresses the need to rigorously advance the science and understanding of the development, feasibility, acceptability and adoption of novel culturally-sensitive motivational strategies to improve dialysis treatment adherence among African Americans with end-stage kidney disease (ESKD). This study specifically aims to:

  1. 1.Gain advanced skills in the development and implementation of novel culturally sensitive motivational strategies
  2. 2.Acquire critical preliminary data for an R01-funded phase II efficacy trial testing the use of these motivational strategies to improve dialysis treatment adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 26, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 20, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

July 26, 2021

Results QC Date

January 9, 2024

Last Update Submit

April 1, 2024

Conditions

End Stage Renal Disease on Dialysis

Keywords

Dialysis treatment adherence; Hemodialysis; African American

Outcome Measures

Primary Outcomes (1)

  • Dialysis Treatment Adherence

    Abstraction of dialysis treatment adherence data from the dialysis units' records which includes data on every treatment that occurred or should have occurred within the time frame. Records will reflect dialysis treatments which were completed, shortened, missed or did not occur due to hospitalizations, ER visits or travel.

    Week 8, i.e. the maintenance phase, days 31 through 60 post-randomization

Secondary Outcomes (6)

  • Change in Autonomous Regulation

    Week 8

  • Change in Autonomy Support

    Week 8

  • Change in Perceived Competence

    Week 8

  • Change in Apathy

    Week 8

  • Change in Optimism

    Week 8

  • +1 more secondary outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care

Intervention

EXPERIMENTAL

Motivational interviewing intervention

Behavioral: Motivational interviewing

Interventions

Motivational interviewingBEHAVIORAL

In this trial, motivational interviewing (MI) is the intervention. The MI sessions will embody the spirit of MI (PACE - Partnership, Acceptance, Compassion and Evocation) and the use of MI strategies (OARS - Open-ended questions, Affirmations, Reflections and Summaries) and MI communication processes (engagement, focusing, evoking and planning).

Also known as: MI
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American
  • Receiving hemodialysis treatments
  • Been on hemodialysis for more than 30 days
  • years of age and older
  • Within a 3-month look back at the time of screening, patients who have missed at least one dialysis session or shortened at least one dialysis session by 15 minutes.

You may not qualify if:

  • Not self-identified as African American
  • Impaired with mental status or severe illness
  • Non-English speaking
  • No documented evidence of dialysis treatment non-adherence
  • Missed or shortened treatments due to hospitalizations or excused travel
  • Terminal condition
  • Living in a nursing home/rehab
  • Planned transplant within the next 3 months
  • Planned conversion to peritoneal dialysis within the next 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt Dialysis Clinic

Nashville, Tennessee, 37204, United States

Location

Vanderbilt Dialysis Clinic East

Nashville, Tennessee, 37214, United States

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Ebele Umeukeje
Organization
Vanderbilt University Medical Center
ebele.m.umeukeje@vumc.org
615-322-3221

Study Officials

  • Ebele M Umeukeje, MD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 12, 2021

Study Start

June 6, 2022

Primary Completion

January 9, 2023

Study Completion

January 9, 2023

Last Updated

April 23, 2024

Results First Posted

March 20, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)