Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

End Stage Renal Disease Clinical Trial

Official title:

Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215655
• Other study ID #: 141143
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: April 27, 2016
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Behavioral:
• Motivational interviewing
Motivational interviewing counselling sessions will be administered to the subjects.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No