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临床试验/NCT02215655
NCT02215655已完成不适用

Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
change in subjects' adherence to phosphate binders

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

change in subjects' adherence to phosphate binders

时间窗: baseline and 2 months

Change from baseline in the following survey at 2 months: - Morisky Medication Adherence Scale (MMAS)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ebele Umeukeje

Fellow

Vanderbilt University

研究点 (2)

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