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

Primary Purpose

End Stage Renal Disease on Dialysis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Renal Disease on Dialysis focused on measuring Dialysis treatment adherence; Hemodialysis; African Americans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Buttonwood DaVita Dialysis 449 N Broad St,
  • Vanderbilt Dialysis ClinicRecruiting
  • Vanderbilt Dialysis Clinic East

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Participants receiving intervention

Arm Description

Standard of Care

Motivational interviewing intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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).
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.
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.

Full Information

First Posted
February 9, 2023
Last Updated
October 18, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05735743
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Actual)
Primary Completion Date
November 1, 2027 (Anticipated)
Study Completion Date
November 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis
Keywords
Dialysis treatment adherence; Hemodialysis; African Americans

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of Care
Arm Title
Participants receiving intervention
Arm Type
Experimental
Arm Description
Motivational interviewing intervention
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing
Other Intervention Name(s)
MI
Intervention Description
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).
Primary Outcome Measure Information:
Title
Dialysis treatment adherence
Description
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.
Time Frame
Baseline to 24 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in Autonomous Regulation
Description
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
Time Frame
Baseline, Week 8, Week 24
Title
Change in Autonomy Support
Description
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.
Time Frame
Baseline, Week 8, Week 24
Title
Change in Perceived competence
Description
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).
Time Frame
Baseline, Week 8, Week 24
Title
Change in Apathy
Description
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.
Time Frame
Baseline, Week 8, Week 24
Title
Change in Optimism
Description
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.
Time Frame
Baseline, Week 8, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebele M Umeukeje, MD, MPH
Phone
615 936 3283
Email
ebele.m.umeukeje@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Marylou Wallace, MPH
Phone
615-322-3221
Email
marylou.wallace@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebele M Umeukeje, MD, MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buttonwood DaVita Dialysis 449 N Broad St,
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19123
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Schrauben
Email
Sarah.Schrauben@pennmedicine.upenn.edu
Facility Name
Vanderbilt Dialysis Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebele Umeukeje, MD, MPH
Phone
615-936-3283
Email
ebele.m.umeukeje@vumc.org
Facility Name
Vanderbilt Dialysis Clinic East
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37214
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebele Umeukeje, MD, MPH
Phone
615-936-3283
Email
ebele.m.umukeje@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
No

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

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