End Stage Renal Disease on Dialysis
Conditions
Keywords
Dialysis treatment adherence; Hemodialysis; African Americans
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).
Interventions
BEHAVIORALMotivational 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).
Sponsors
Vanderbilt University Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis Treatment Adherence - Shortened Session | Baseline to Week 12 | 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. A shortened session is defined as a session that is shortened by 15 minutes or more (y/n, repeated measure). |
| Change in Perceived Competence | Week 8 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis Treatment Adherence - Shortened Session | Week 13 to Week 24 | 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. A shortened session is defined as a session that is shortened by 15 minutes or more (y/n, repeated measure). |
| Dialysis Treatment Adherence - Missed Session | Baseline to Week 12 | 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. A missed session is defined as an unplanned and unexcused absence from treatment (y/n, repeated measure). |
| Dialysis Treatment Adherence - Missed Minutes | Baseline to Week 12 | 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. Missed minutes is represented as the percentage of total prescribed minutes missed (%). |
| Change in Perceived Competence | Week 24 | 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 Autonomous Regulation | Week 8 | 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 | Week 8 | 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 Apathy | Week 8 | 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 | Week 8 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREbele M Umeukeje, MD, MPH
Vanderbilt University Medical Center
Outcome results
None listed