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Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring phosphate binder adherence, autonomous motivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Motivational interviewing

No intervention: control group

Arm Description

Motivational interviewing counselling will be administered to the subjects

No motivational interviewing counselling will be administered to the subjects

Outcomes

Primary Outcome Measures

change in subjects' adherence to phosphate binders
Change from baseline in the following survey at 2 months: - Morisky Medication Adherence Scale (MMAS)

Secondary Outcome Measures

change in attitudes towards phosphate binder therapy
Change from baseline in the following survey/questionnaire at 2 months: - Autonomous Regulation Scale (AR)
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)

Full Information

First Posted
August 7, 2014
Last Updated
April 27, 2016
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02215655
Brief Title
Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
Official Title
Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
phosphate binder adherence, autonomous motivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational interviewing
Arm Type
Active Comparator
Arm Description
Motivational interviewing counselling will be administered to the subjects
Arm Title
No intervention: control group
Arm Type
No Intervention
Arm Description
No motivational interviewing counselling will be administered to the subjects
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
Motivational interviewing counselling sessions will be administered to the subjects.
Primary Outcome Measure Information:
Title
change in subjects' adherence to phosphate binders
Description
Change from baseline in the following survey at 2 months: - Morisky Medication Adherence Scale (MMAS)
Time Frame
baseline and 2 months
Secondary Outcome Measure Information:
Title
change in attitudes towards phosphate binder therapy
Description
Change from baseline in the following survey/questionnaire at 2 months: - Autonomous Regulation Scale (AR)
Time Frame
baseline and 2 months
Title
change in perceived providers' autonomy support towards phosphate binder therapy
Description
Change from baseline in the following survey/questionnaire at 2 months: - Health Care Climate Questionnaire (HCC)
Time Frame
baseline and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebele M Umeukeje, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

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