End Stage Renal DiseaseNCT02215655
Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
A study testing Motivational interviewing in people with End Stage Renal Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
Hyperphosphatemia in end-stage renal disease (ESRD) patients is a non-traditional risk factor for all-cause and cardiovascular mortality. Non-adherence to phosphate binders is as high as 74% in ESRD patients and has been shown to be most related to psychosocial factors including attitudes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- 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
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults age 18 years or older
- Receiving phosphate binder therapy currently
- English speaking
Who cannot join
- Non- English speaking
- Known diagnosis of psychosis or dementia, limiting ability to provide informed consent
- Any medical condition that precludes participation in the study including deafness, dying etc.
- Initial Morisky Medication Adherence score greater than 6
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Hyperphosphatemia in end-stage renal disease (ESRD) patients is a non-traditional risk factor for all-cause and cardiovascular mortality. Non-adherence to phosphate binders is as high as 74% in ESRD patients and has been shown to be most related to psychosocial factors including attitudes. There is limited data on the influence of attitudes and perceived autonomy support on phosphate binder adherence and these two psychosocial constructs can be positively influenced through the use of motivational interviewing skills to increase autonomous motivation. Furthermore, racial disparities are known to exist in ESRD however and there are still gaps, which exist in understanding the determinants of disparities in adherence in vulnerable patients with ESRD.
In this study, the investigators seek to determine the impact of motivational interviewing on phosphate binder adherence in diverse ESRD patients. The investigators will ask all the subjects to fill out surveys mainly regarding their attitudes; perceived providers' autonomy support and phosphate binder adherence. The investigators will administer motivational counseling to subjects in the intervention arm of the study, at baseline and 1 month after recruitment. The investigators will ask all the subjects to fill out the same surveys 2 months after recruitment and the investigators will compare subjects who underwent motivational interviewing to those who did not.
- Conditions
- End Stage Renal Disease
- Being tested
- Motivational interviewing
- Keywords
- phosphate binder adherence, autonomous motivation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
Motivational interviewing counselling sessions will be administered to the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing | Active comparator | Motivational interviewing counselling will be administered to the subjects Receives: Behavioral: Motivational interviewing |
| No intervention: control group | No intervention | No motivational interviewing counselling will be administered to the subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in subjects' adherence to phosphate binders
Change from baseline in the following survey at 2 months:
- Morisky Medication Adherence Scale (MMAS)
Measured: baseline and 2 months
Secondary outcomes (2)
change in attitudes towards phosphate binder therapy
Change from baseline in the following survey/questionnaire at 2 months:
- Autonomous Regulation Scale (AR)
Measured: baseline and 2 months
change in perceived providers' autonomy support towards phosphate binder therapy
Change from baseline in the following survey/questionnaire at 2 months:
- Health Care Climate Questionnaire (HCC)
Measured: baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebele Umeukeje, Vanderbilt University
- Investigators
- Ebele M Umeukeje, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215655
- Sponsor's protocol ID
- 141143
- Status last verified
- Apr 2016
- First submitted
- 7 Aug 2014
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
- ClinicalTrials.gov ID
- NCT02215655
- Acronym / sponsor ID
- 141143
- Conditions
- End Stage Renal Disease
- Keywords
- phosphate binder adherence, autonomous motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Aug 2014 (estimated)
- 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.
Hyperphosphatemia in end-stage renal disease (ESRD) patients is a non-traditional risk factor for all-cause and cardiovascular mortality. Non-adherence to phosphate binders is as high as 74% in ESRD patients and has been shown to be most related to psychosocial factors including attitudes. There is limited data on the influence of attitudes and perceived autonomy support on phosphate binder adherence and these two psychosocial constructs can be positively influenced through the use of motivational interviewing skills to increase autonomous motivation. Furthermore, racial disparities are known to exist in ESRD however and there are still gaps, which exist in understanding the determinants of disparities in adherence in vulnerable patients with ESRD.
In this study, the investigators seek to determine the impact of motivational interviewing on phosphate binder adherence in diverse ESRD patients. The investigators will ask all the subjects to fill out surveys mainly regarding their attitudes; perceived providers' autonomy support and phosphate binder adherence. The investigators will administer motivational counseling to subjects in the intervention arm of the study, at baseline and 1 month after recruitment. The investigators will ask all the subjects to fill out the same surveys 2 months after recruitment and the investigators will compare subjects who underwent motivational interviewing to those who did not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing | Active comparator | Behavioral: Motivational interviewingMotivational interviewing counselling will be administered to the subjects |
| No intervention: control group | No intervention | –No motivational interviewing counselling will be administered to the subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age 18 years or older
- Receiving phosphate binder therapy currently
- English speaking
Key exclusion criteria (4 listed)
- Non- English speaking
- Known diagnosis of psychosis or dementia, limiting ability to provide informed consent
- Any medical condition that precludes participation in the study including deafness, dying etc.
- Initial Morisky Medication Adherence score greater than 6
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 interviewingMotivational interviewing counselling sessions will be administered to the subjects. | Behavioural | Motivational interviewing |
Primary outcome
change in subjects' adherence to phosphate binders
Time frame: baseline and 2 months
Change from baseline in the following survey at 2 months: - Morisky Medication Adherence Scale (MMAS)
2 secondary outcomes
change in attitudes towards phosphate binder therapy
Time frame: baseline and 2 months
change in perceived providers' autonomy support towards phosphate binder therapy
Time frame: baseline and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
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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 principal investigator
Vanderbilt University
1 site 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, run by Vanderbilt University at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in subjects' adherence to phosphate binders (time frame: baseline and 2 months). 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 29 Apr 2016.