Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

Study Overview
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Brief Summary
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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.

Official Title
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Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Behavioral: Motivational interviewing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Motivational interviewing<br>Motivational interviewing counselling will be administered to the subjects | Behavioral: Motivational interviewing<br>* Motivational interviewing counselling sessions will be administered to the subjects.<br>|
| No Intervention: No intervention: control group<br>No motivational interviewing counselling will be administered to the subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in subjects' adherence to phosphate binders | Change from baseline in the following survey at 2 months: - Morisky Medication Adherence Scale (MMAS) | baseline and 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in attitudes towards phosphate binder therapy | Change from baseline in the following survey/questionnaire at 2 months: - Autonomous Regulation Scale (AR) | 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) | baseline and 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phosphate binder adherence, autonomous motivation