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

Study Overview
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Brief Summary
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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).

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

Conditions
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End Stage Renal Disease on Dialysis

Intervention / Treatment
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* Behavioral: Motivational interviewing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Standard of Care | |
| Experimental: Participants receiving intervention<br>Motivational interviewing intervention | Behavioral: Motivational interviewing<br>* 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).<br>* Other names: MI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis treatment adherence; Hemodialysis; African Americans