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临床试验/NCT03211130
NCT03211130已完成早期 1 期

Randomized Controlled Pilot Study of a SystemCHANGE™ Medication Adherence Intervention in Older Adult Stroke Survivors

University of Missouri, Kansas City2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年11月28日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Acceptability and feasibility

研究概览

简要总结

This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention in older adult stroke survivors to improve medication adherence. Half the participants will receive the SystemCHANGE intervention, while the other half will receive the attention-control education intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • age ≥50 years old
  • receives post-stroke care with Saint Luke's Neurological Consultants
  • prescribed at least 1, once a day, antithrombotic medication
  • able to provide informed consent
  • able to open an electronic cap
  • able to self-administer medications
  • has or has access to a telephone
  • has no cognitive impairment as determined by a score of 4 or greater on The Six- item Screener (SIS).

排除标准

  • 未提供

研究组 & 干预措施

SystemCHANGE™

Experimental

干预措施: SystemCHANGE™ (Behavioral)

Attention-Control

Active Comparator

干预措施: Attention-Control (Behavioral)

结局指标

主要结局

Acceptability and feasibility

时间窗: one point in time at the end of the maintenance phase which is 3 months after randomization into groups

Open ended questionnaire

次要结局

  • Social Support(One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.)
  • Perceived Health(One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.)
  • Personal Systems Behaviors(One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.)
  • Medication Adherence(after randomization through end of maintenance phase for a total of 3 months)

研究者

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

Cynthia Russell

Professor, School of Nursing

University of Missouri, Kansas City

研究点 (2)

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