Back to resultsMotivational Strategies To Empower African Americans To Improve Dialysis Adherence (MoVE)
Primary Purpose
End Stage Renal Disease on Dialysis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing
Sponsored by
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
Inclusion Criteria:
- African American
- Receiving hemodialysis treatments
- Been on hemodialysis for more than 30 days
- 18 years of age and older
- Within a 3-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 3 months
- Planned conversion to peritoneal dialysis within the next 3 months
Sites / Locations
- Vanderbilt Dialysis Clinic
- Vanderbilt Dialysis Clinic East
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
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
NCT ID
NCT05003115
First Posted
July 26, 2021
Last Updated
January 11, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05003115
Brief Title
Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
Acronym
MoVE
Official Title
MoVE: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
January 9, 2023 (Actual)
Study Completion Date
January 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study addresses the need to rigorously advance the science and understanding of the development, feasibility, acceptability and adoption of novel culturally-sensitive motivational strategies to improve dialysis treatment adherence among African Americans with end-stage kidney disease (ESKD). This study specifically aims to:
Gain advanced skills in the development and implementation of novel culturally sensitive motivational strategies
Acquire critical preliminary data for an R01-funded phase II efficacy trial testing the use of these motivational strategies to improve dialysis treatment adherence.
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
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of Care
Arm Title
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 3 months 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 6, Week 10
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 6, Week 10
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 6, Week 10
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 6, Week 10
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 6, Week 10
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 3-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 3 months
Planned conversion to peritoneal dialysis within the next 3 months
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
Vanderbilt Dialysis Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Vanderbilt Dialysis Clinic East
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37214
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
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