End Stage Renal Disease on DialysisNCT05735743
MoVE Trial: 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 6 sites in United States.
Trial 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. 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
- 176 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Oct 2023to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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.
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 6 months
- Planned conversion to peritoneal dialysis within the next 6 months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Vanderbilt Dialysis Clinic
Nashville, Tennessee, 37204
Dialysis Clinic, Inc.
Nashville, Tennessee, 37208
Vanderbilt Dialysis Clinic East
Nashville, Tennessee, 37214
DaVita Philadelphia PMC Dialysis
Philadelphia, Pennsylvania, 19104
DaVita University City Dialysis
Philadelphia, Pennsylvania, 19104
Buttonwood DaVita Dialysis 449 N Broad St,
Philadelphia, PA 19123, Pennsylvania, 19123
About this study
Official title: MoVE Trial: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
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).
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Motivational interviewing
- Keywords
- Dialysis treatment adherence; Hemodialysis; African Americans
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 |
| Participants receiving 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 - Shortened Session
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).
Measured: Baseline to Week 12
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
Secondary outcomes (14)
Dialysis Treatment Adherence - Shortened Session
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).
Measured: Week 13 to Week 24
Dialysis Treatment Adherence - Missed Session
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).
Measured: Baseline to Week 12
Dialysis Treatment Adherence - Missed Session
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).
Measured: Week 13 to Week 24
Dialysis Treatment Adherence - Missed Minutes
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 (%).
Measured: Baseline to Week 12
Dialysis Treatment Adherence - Missed Minutes
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 (%).
Measured: Week 13 to 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).
Measured: Week 24
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 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 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.
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 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.
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.
Measured: 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.
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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start9 Oct 2023
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- 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
- NCT05735743
- Sponsor's protocol ID
- 221538 - MoVE Trial
- Other IDs
- 1R01DK133530-01
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MoVE Trial: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
- ClinicalTrials.gov ID
- NCT05735743
- Acronym / sponsor ID
- 221538 - MoVE Trial
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- Dialysis treatment adherence; Hemodialysis; African Americans
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of Care |
| Participants receiving intervention | Experimental | Behavioral: Motivational interviewingMotivational interviewing intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingAlso: MIIn 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). | Behavioural | Participants receiving intervention |
Primary outcome
Dialysis Treatment Adherence - Shortened Session
Time frame: 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
Time frame: 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).
14 secondary outcomes
Dialysis Treatment Adherence - Shortened Session
Time frame: Week 13 to Week 24
Dialysis Treatment Adherence - Missed Session
Time frame: Baseline to Week 12
Dialysis Treatment Adherence - Missed Session
Time frame: Week 13 to Week 24
Dialysis Treatment Adherence - Missed Minutes
Time frame: Baseline to Week 12
Dialysis Treatment Adherence - Missed Minutes
Time frame: Week 13 to Week 24
Change in Perceived Competence
Time frame: Week 24
Change in Autonomous Regulation
Time frame: Week 8
Change in Autonomous Regulation
Time frame: Week 24
Change in Autonomy Support
Time frame: Week 8
Change in Autonomy Support
Time frame: Week 24
Change in Apathy
Time frame: Week 8
Change in Apathy
Time frame: Week 24
Change in Optimism
Time frame: Week 8
Change in Optimism
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebele M Umeukeje, MD, MPH principal investigator
Vanderbilt University Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with End Stage Renal Disease on Dialysis, run by Vanderbilt University Medical Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis Treatment Adherence - Shortened Session (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.