Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

NCT02215655 | Completed

• 1 other identifier: 141143
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

phosphate binder adherence; autonomous motivation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• change in attitudes towards phosphate binder therapy

  baseline and 2 months

• change in perceived providers' autonomy support towards phosphate binder therapy

  baseline and 2 months

Study Arms (2)

Motivational interviewing

ACTIVE COMPARATOR

Motivational interviewing counselling will be administered to the subjects

Behavioral: Motivational interviewing

No intervention: control group

NO INTERVENTION

No motivational interviewing counselling will be administered to the subjects

Interventions

Motivational interviewing BEHAVIORAL

Motivational interviewing counselling sessions will be administered to the subjects.

Motivational interviewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 years or older
• Receiving phosphate binder therapy currently
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ebele M Umeukeje, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 13, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 29, 2016

Record last verified: 2016-04

Locations

US (1)