跳至主要内容
临床试验/NCT05928598
NCT05928598招募中不适用

Drug-Resistant Epilepsy (DRE) Goals for Epilepsy Clinical Visits mHealth Epilepsy Visit Planner Trial

University of Michigan2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2023年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
152
试验地点
2
主要终点
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), difference in mean score between trial arms

研究概览

简要总结

The purpose of this project is to conduct a trial to assess whether patients that receive a tablet-based waiting room priority communication tool (the "Epilepsy Visit Planner") have improved outcomes compared to patients that do not receive the tool.

The project's hypotheses are:

  • Patients that receive the Epilepsy Visit Planner will have improved patient-provider communication compared to the non-planner group.
  • Patients that receive the Epilepsy Visit Planner will have improved quality of life scores.
  • The Epilepsy Visit Planner will score highly on process measures of feasibility and acceptability, demonstrating suitability for future larger scale study.

Additionally, there is a related survey project that is not part of the clinical trial and will not be included in this registration information.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), difference in mean score between trial arms

时间窗: Baseline

This is a 10-item measure with Likert scale (range 1-5 for each response) with a score range of 10-50 (higher score indicating higher perceived efficacy in communicating with providers).

次要结局

  • Acceptability of Intervention Measure, assessed in intervention arm(Baseline - intervention arm only)
  • Quality of Life in Epilepsy (QOLIE-10) inventory, difference in mean score between trial arms(3 months after baseline visit)
  • Perceived Involvement in Care (PICS), difference in mean score between trial arms(Baseline)
  • Feasibility, assessed in intervention arm(Baseline - intervention arm only)

研究者

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

Chloe Hill

Assistant Professor of Neurology

University of Michigan

研究点 (2)

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