NCT05735743

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

75
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not recruiting

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

Study Progress63%
Oct 2023Nov 2027

First Submitted

Initial submission to the registry

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

February 9, 2023

Last Update Submit

April 20, 2026

Conditions

Keywords

Dialysis treatment adherence; Hemodialysis; African Americans

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 INTERVENTION

Standard of Care

Participants receiving intervention

EXPERIMENTAL

Motivational interviewing intervention

Behavioral: Motivational interviewing

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).

Also known as: MI
Participants receiving 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 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

Location

DaVita University City Dialysis

Philadelphia, Pennsylvania, 19104, United States

Location

Buttonwood DaVita Dialysis 449 N Broad St,

Philadelphia, PA 19123, Pennsylvania, 19123, United States

Location

Vanderbilt Dialysis Clinic

Nashville, Tennessee, 37204, United States

Location

Dialysis Clinic, Inc.

Nashville, Tennessee, 37208, 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

Study Officials

  • Ebele M Umeukeje, MD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations