Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Behavioral: Motivational interviewing

• Registration Number: NCT02215655
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-13
• Study Start: 2014-09
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motivational interviewing	Motivational interviewing	Motivational interviewing counselling will be administered to the subjects

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change in attitudes towards phosphate binder therapy	baseline and 2 months	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	baseline and 2 months	Change from baseline in the following survey/questionnaire at 2 months: - Health Care Climate Questionnaire (HCC)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States