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Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02215655
Enrollment
150
Registered
2014-08-13
Start date
2014-09-30
Completion date
2015-05-31
Last updated
2016-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

phosphate binder adherence, autonomous motivation

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.

Interventions

BEHAVIORALMotivational interviewing

Motivational interviewing counselling sessions will be administered to the subjects.

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in subjects' adherence to phosphate bindersbaseline and 2 monthsChange from baseline in the following survey at 2 months: \- Morisky Medication Adherence Scale (MMAS)

Secondary

MeasureTime frameDescription
change in attitudes towards phosphate binder therapybaseline and 2 monthsChange from baseline in the following survey/questionnaire at 2 months: \- Autonomous Regulation Scale (AR)
change in perceived providers' autonomy support towards phosphate binder therapybaseline and 2 monthsChange from baseline in the following survey/questionnaire at 2 months: \- Health Care Climate Questionnaire (HCC)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026