Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

NCT ID: NCT02215655

Last Updated: 2016-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-05-31

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Motivational interviewing

Motivational interviewing counselling will be administered to the subjects

Group Type: ACTIVE_COMPARATOR

Motivational interviewing

Intervention Type: BEHAVIORAL

Motivational interviewing counselling sessions will be administered to the subjects.

No intervention: control group

No motivational interviewing counselling will be administered to the subjects

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motivational interviewing

Motivational interviewing counselling sessions will be administered to the subjects.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Ebele Umeukeje

Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebele M Umeukeje, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

141143

Identifier Type: -

Identifier Source: org_study_id