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OpenTrials
Completed

NCT Number: NCT02215655

Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

Motivational interviewing counselling sessions will be administered to the subjects.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2014
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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