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临床试验/NCT01296594
NCT01296594已完成不适用

Improving Antihypertensive Medication Adherence

UConn Health2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
self reports of medication adherence

研究概览

简要总结

Poor adherence to antihypertensive medications is associated with morbidity, and data suggest that substance abuse may contribute to poor adherence. Contingency management (CM), an intervention highly efficacious for improving outcomes of substance abusers, shows promise in improving medication adherence in a handful of small trials. CM involves providing tangible reinforcement each time the behavior (medication ingestion) is exhibited. Thus far, studies evaluating CM for increasing medication adherence have utilized MEMS caps, but reinforcement of adherence via MEMS caps is done relatively infrequently and with delay, hindering its efficacy. A widely utilized technology that may be more appropriate for reinforcing medication adherence is cell phones, which can record the process of pill ingestion through video functions. As regular monitoring and feedback is important in the efficacy of CM, patients can be provided with daily messages regarding adherence and CM earnings. In this pilot study, we propose to randomize 40 hypertensive substance abusing patients with suboptimal adherence to antihypertensive medications to one of two 12-week treatment conditions: (1) usual care, or (2) usual care with cell phone monitoring and CM. In the CM condition, patients will carry a cell phone and record and send in time- and date-stamped self videos of medication ingestion. These patients will receive congratulatory messages or reminders about adherence, and they will earn vouchers each time medication ingestion occurs at the appropriate time, along with bonuses for sustained adherence. We hypothesize that the CM condition will improve self report and pill count measurements of medication adherence and that it will result in decreased blood pressure. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve medication adherence.

研究设计

研究类型
Interventional
分配方式
Non 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

  • age >18 years
  • have been prescribed one or more antihypertensive medications
  • blood pressure of >120 mmHg systolic or >80 mmHg diastolic
  • substance use problem
  • willing to use a cell phone to record medication ingestion for three months
  • have a valid photo ID (driver's license, passport, state ID) and are willing to sign an off-campus property transfer form and return study equipment at the end of study participation

排除标准

  • uncontrolled psychiatric disorders
  • significant cognitive impairment
  • non-English speaking

研究组 & 干预措施

Usual Care

Active Comparator

干预措施: Usual Care (Other)

usual care with cell phone monitoring and CM

Experimental

In the CM condition, patients will carry a cell phone and record and send in time- and date-stamped self videos of medication ingestion.

干预措施: Contingency Management (Behavioral)

结局指标

主要结局

self reports of medication adherence

时间窗: month 3

次要结局

  • ambulatory (24-hour) blood pressure(month 3)

研究者

发起方
UConn Health
申办方类型
Other
责任方
Sponsor

研究点 (2)

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