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

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05003115
Collaborator
National Institutes of Health (NIH) (NIH)
30
2
2
4.9
15
3.1

Study Details

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:

  1. Gain advanced skills in the development and implementation of novel culturally sensitive motivational strategies

  2. Acquire critical preliminary data for an R01-funded phase II efficacy trial testing the use of these motivational strategies to improve dialysis treatment adherence.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational interviewing
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
MoVE: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
Actual Study Start Date :
Jun 6, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard of Care

Standard of Care

Experimental: Intervention

Motivational interviewing 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).
Other Names:
  • MI
  • Outcome Measures

    Primary Outcome Measures

    1. Dialysis treatment adherence [Baseline to 3 months post-intervention]

      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

    1. Change in Autonomous Regulation [Baseline, Week 6, Week 10]

      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

    2. Change in Autonomy Support [Baseline, Week 6, Week 10]

      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.

    3. Change in Perceived competence [Baseline, Week 6, Week 10]

      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).

    4. Change in Apathy [Baseline, Week 6, Week 10]

      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.

    5. Change in Optimism [Baseline, Week 6, Week 10]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt Dialysis Clinic Nashville Tennessee United States 37204
    2 Vanderbilt Dialysis Clinic East Nashville Tennessee United States 37214

    Sponsors and Collaborators

    • Vanderbilt University Medical Center
    • National Institutes of Health (NIH)

    Investigators

    • Principal Investigator: Ebele M Umeukeje, MD, MPH, Vanderbilt University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ebele Umeukeje, Assistant Professor of Medicine, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05003115
    Other Study ID Numbers:
    • 211127
    First Posted:
    Aug 12, 2021
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ebele Umeukeje, Assistant Professor of Medicine, Vanderbilt University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 21, 2022