MoVE Trial: Motivational Strategies to Empower African Americans to Improve Dialysis Adherence

End Stage Renal Disease on Dialysis Clinical Trial

Official title:

MoVE Trial: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735743
• Other study ID #: 221538 - MoVE Trial
• Secondary ID: 1R01DK133530-01
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: November 1, 2027

Study information

• Verified date: October 2023
• Source: Vanderbilt University Medical Center
• Contact: Ebele M Umeukeje, MD, MPH
• Phone: 615 936 3283
• Email: ebele.m.umeukeje[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic

Intervention

Behavioral:
• Motivational interviewing
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).

Locations

Country	Name	City	State
United States	Vanderbilt Dialysis Clinic	Nashville	Tennessee
United States	Vanderbilt Dialysis Clinic East	Nashville	Tennessee
United States	Buttonwood DaVita Dialysis 449 N Broad St,	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 24 weeks post-intervention
Secondary	Change in Autonomous Regulation	Change in autonomous regulation will be measured by the 6-item Autonomous Regulation (AR) questionnaire. Questions range in score from 1 to 7, and overall score is a mean of all items (range 1 - 7). Lower scores reflect less autonomous regulation, and higher scores reflect greater autonomous regulation	Baseline, Week 8, Week 24
Secondary	Change in Autonomy Support	Change in autonomy support will be measured by the 6-item Health Care Climate (HCC) questionnaire. Questions range in score from 1 to 7, and overall score is a mean of all items (range 1 - 7). Lower scores reflect less autonomous support, and higher scores reflect greater autonomous support.	Baseline, Week 8, Week 24
Secondary	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).	Baseline, Week 8, Week 24
Secondary	Change in Apathy	Change in apathy will be measured by the 7-item Apathy Evaluation Scale survey (AES-S) which measures three domains of apathy: deficits in goal-directed behavior; a decrement in goal-related thought content; and emotional indifference with flat affect. Each question ranges in score from 1 to 4. Item 3 is reverse-scored and then the sum of the 7 item scores is calculated. Range of scores is 7-28.	Baseline, Week 8, Week 24
Secondary	Change in Optimism	Change in optimism will be measured by the 10-item Life Orientation Test - Revised (LOT-R) questionnaire which assesses individual differences in generalized optimism versus pessimism. Only 6 of the 10 items on the revised LOT are used to derive an optimism score. Four of the items are filler items and are not used in scoring. Of the 6 survey questions utilized, each question ranges in score from 1 to 5. Thus, scores in principle can range from 6 to 30.	Baseline, Week 8, Week 24