MoVE Trial: Motivational Strategies to Empower African Americans to Improve Dialysis Adherence
2 other identifiers
interventional
176
1 country
6
Brief Summary
MoVE Trial is a randomized clinical trial designed to rigorously test the impact of a behavioral intervention (culturally tailored motivational interviewing - (MOVE)) delivered by trained health coaches, on hemodialysis treatment non-adherence. It is a a two-arm, parallel group randomized clinical trial with 24-week follow-up. It involves completion of surveys by patients enrolled in the study. It also involves participation in motivational interviewing sessions by patients who are randomized to the intervention (MI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
October 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
April 23, 2026
April 1, 2026
4.1 years
February 9, 2023
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dialysis Treatment Adherence - Shortened Session
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. A shortened session is defined as a session that is shortened by 15 minutes or more (y/n, repeated measure).
Baseline to Week 12
Change in Perceived Competence
Change in perceived competence will be measured by the 8-item Perceived Kidney Disease Self-Management Scale (PKDSMS) questionnaire. Each question ranges in score from 1 to 5. Four of the items (#s 1, 2, 6, 7) are reversed-scored. The score is the sum of the 8 individual items. The total PKDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's (dialysis).
Week 8
Secondary Outcomes (14)
Dialysis Treatment Adherence - Shortened Session
Week 13 to Week 24
Dialysis Treatment Adherence - Missed Session
Baseline to Week 12
Dialysis Treatment Adherence - Missed Session
Week 13 to Week 24
Dialysis Treatment Adherence - Missed Minutes
Baseline to Week 12
Dialysis Treatment Adherence - Missed Minutes
Week 13 to Week 24
- +9 more secondary outcomes
Study Arms (2)
Standard of Care
NO INTERVENTIONStandard of Care
Participants receiving intervention
EXPERIMENTALMotivational interviewing intervention
Interventions
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).
Eligibility Criteria
You may qualify if:
- African American
- Receiving hemodialysis treatments
- Been on hemodialysis for more than 30 days
- years of age and older
- Within a 2-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 6 months
- Planned conversion to peritoneal dialysis within the next 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
DaVita Philadelphia PMC Dialysis
Philadelphia, Pennsylvania, 19104, United States
DaVita University City Dialysis
Philadelphia, Pennsylvania, 19104, United States
Buttonwood DaVita Dialysis 449 N Broad St,
Philadelphia, PA 19123, Pennsylvania, 19123, United States
Vanderbilt Dialysis Clinic
Nashville, Tennessee, 37204, United States
Dialysis Clinic, Inc.
Nashville, Tennessee, 37208, United States
Vanderbilt Dialysis Clinic East
Nashville, Tennessee, 37214, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ebele M Umeukeje, MD, MPH
Vanderbilt University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
February 9, 2023
First Posted
February 21, 2023
Study Start
October 9, 2023
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share