Clinical trial NCT05735743: MoVE Trial: Motivational Strategies to Empower African Americans to Improve Dialysis Adherence
Official title: MoVE Trial: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Keywords: Dialysis treatment adherence; Hemodialysis; African Americans
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-02-21
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: Inclusion Criteria:

* African American
* Receiving hemodialysis treatments
* Been on hemodialysis for more than 30 days
* 18 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dialysis treatment adherence
timeFrame: Baseline to 24 weeks post-intervention
Secondary outcomes:
measure: Change in Autonomous Regulation
timeFrame: Baseline, Week 8, Week 24
measure: Change in Autonomy Support
timeFrame: Baseline, Week 8, Week 24
measure: Change in Perceived competence
timeFrame: Baseline, Week 8, Week 24
measure: Change in Apathy
timeFrame: Baseline, Week 8, Week 24
measure: Change in Optimism
timeFrame: Baseline, Week 8, Week 24
Other outcomes:
Locations:
city: Philadelphia, PA 19123
country: United States
facility: Buttonwood DaVita Dialysis 449 N Broad St,
state: Pennsylvania
city: Philadelphia
country: United States
facility: DaVita Philadelphia PMC Dialysis
state: Pennsylvania
city: Philadelphia
country: United States
facility: DaVita University City Dialysis
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Dialysis Clinic
state: Tennessee
city: Nashville
country: United States
facility: Dialysis Clinic, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Dialysis Clinic East
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ebele M Umeukeje, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: