End Stage Renal Disease on DialysisMoVENCT05003115
Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
A study testing Motivational interviewing in people with End Stage Renal Disease on Dialysis, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2022to 9 Jan 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Living in a nursing home/rehab
- Planned transplant within the next 3 months
- Planned conversion to peritoneal dialysis within the next 3 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt Dialysis Clinic
Nashville, Tennessee, 37204
Vanderbilt Dialysis Clinic East
Nashville, Tennessee, 37214
About this study
Official title: MoVE: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
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.
Read the detailed description
Hemodialysis treatment non-adherence is a public health issue because of its association with excessive hospitalizations, high morbidity, mortality, and increased financial costs. Compared to whites, African Americans have a four-fold higher prevalence of end stage kidney disease (EKSD), higher non-adherence rates to hemodialysis, and higher odds of hospitalizations. Motivational interviewing, an evidence-based intervention that creates a bond between patients and providers, targets improvement in motivation-related psychosocial factors associated with adherence behaviors. Interventions for such factors are typically developed based on the dominant culture and may not be valid and generalizable to minority groups. Culturally tailored interventions lead to more durable change in African Americans yet there is a lack of studies testing the efficacy of such approaches to improve hemodialysis treatment adherence in African Americans. Use of culturally tailored motivational interviewing in African Americans with ESKD will promote health equity by improving dialysis treatment adherence, reducing hospitalizations, and enhancing other critical outcomes.
Our long-term goal is to establish culturally sensitive strategies and multi-level interactions to improve outcomes in kidney disease. The overall objective of this project is to evaluate the efficacy of a culturally tailored motivational interviewing intervention developed using a rigorous theoretical framework on improving hemodialysis treatment adherence in African Americans with ESKD. The central hypothesis is that culturally tailored motivational interviewing will lead to improved hemodialysis treatment adherence. We will test this hypothesis in the following Specific Aims in a randomized clinical trial (RCT) in African American patients with ESKD. Compared to usual dialysis care, we aim to: Evaluate the efficacy of 8 weeks of culturally tailored motivational interviewing (MoVE) on improving hemodialysis adherence at (1) 3 months, and (2) 6 months post-randomization. At the successful completion of the proposed research, the expected outcomes will include evidence of the efficacy of culturally tailored motivational interviewing on improving hemodialysis treatment adherence in African American patients with ESKD. The proposed research is innovative because of the novel application of a culturally tailored, evidence-based behavioral intervention developed using a rigorous theoretical network (PEN-3); the use of specifically-trained health coaches to optimize the intervention delivery; and the focus on understanding and overrepresented African American patients with ESKD to address the public health issue of hemodialysis treatment of non-adherence. Study results will provide a strong basis for conducting an effectiveness and implementation trial, which is expected to have a significant impact on hemodialysis adherence, hospitalizations, morbidity, and mortality. This research strongly aligns with NIDDK's mission to promote health equity by addressing health disparities in kidney disease.
Hemodialysis treatment non-adherence is an important modifiable contributor to end stage kidney disease (ESKD), with critical public health relevance to patients, providers, and health systems due to its association with excessive hospitalizations, exorbitant financial burden, and increase morbidity and mortality. Compared to Whites, African Americans ESKD patients have a four-fold higher ESKD prevalence, persistently higher hospitalization and rehospitalization risk, and higher rates of dialysis treatment non-adherence. The goals of this proposal are to: (1) evaluate the efficacy of culturally tailored motivational interviewing on improving hemodialysis treatment adherence in African Americans; (2) provide a strong basis for conducting a future effectiveness and implementation trial using evidence-based, culturally tailored motivational interviewing intervention to improve hemodialysis adherence, and reduce hospitalizations, morbidity, mortality, and exorbitant financial burden associated with dialysis treatment non-adherence; and (3) promote health equity by reducing existing health disparities and optimizing outcomes in ESKD.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Motivational interviewing
- Keywords
- Dialysis treatment adherence; Hemodialysis; African American
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
Also called MI
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard of Care |
| Intervention | Experimental | Motivational interviewing intervention Receives: Behavioral: Motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8, i.e. the maintenance phase, days 31 through 60 post-randomization
Secondary outcomes (6)
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
Measured: Week 8
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.
Measured: Week 8
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).
Measured: Week 8
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, with higher scores indicating more apathy.
Measured: Week 8
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. There are no 'cut-offs' for optimism or pessimism; the scale is a continuous dimension of variability between the two with higher scores indicating high optimism (low pessimism) and lower scores indicating high pessimism (low optimism).
Measured: Week 8
Perceived Expectancies Index
The Dispositional Optimism items are #s 1, 3, 5, \& 7; The Perceived Competence items are #s 2, 4, 6, \& 8. Items # 2, 5, 6, \& 7 need to be reverse scored. The overall score is calculated by summating the scores after reverse scoring 2,5,6, and 7. The score ranges from 8-48 with 48 being the highest perceived expectancies. The score can also be broken down into the above scales.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start6 Jun 2022
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Ebele Umeukeje, Vanderbilt University Medical Center
- Investigators
- Ebele M Umeukeje, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003115
- Sponsor's protocol ID
- 211127 - MoVE
- Other IDs
- 5R03DK129626-02
- Acronym
- MoVE
- Status last verified
- Apr 2024
- First submitted
- 26 Jul 2021
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No