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Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

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ClinicalTrials.gov Identifier: NCT02215655
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ebele Umeukeje, Vanderbilt University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Behavioral: Motivational interviewing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
Study Start Date : September 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Active Comparator: Motivational interviewing
Motivational interviewing counselling will be administered to the subjects
Behavioral: Motivational interviewing
Motivational interviewing counselling sessions will be administered to the subjects.

No Intervention: No intervention: control group
No motivational interviewing counselling will be administered to the subjects



Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. change in attitudes towards phosphate binder therapy [ Time Frame: baseline and 2 months ]

    Change from baseline in the following survey/questionnaire at 2 months:

    - Autonomous Regulation Scale (AR)


  2. change in perceived providers' autonomy support towards phosphate binder therapy [ Time Frame: baseline and 2 months ]

    Change from baseline in the following survey/questionnaire at 2 months:

    - Health Care Climate Questionnaire (HCC)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults age 18 years or older
  • Receiving phosphate binder therapy currently
  • English speaking

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215655


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Ebele M Umeukeje, MD Vanderbilt University

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Responsible Party: Ebele Umeukeje, Fellow, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02215655    
Other Study ID Numbers: 141143
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Keywords provided by Ebele Umeukeje, Vanderbilt University:
phosphate binder adherence
autonomous motivation
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency