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临床试验/NCT05900687
NCT05900687尚未招募不适用

Developing, Refining, and Testing a Mobile Health Question Prompt List in Gastroesophageal Reflux Disease

Stanford University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年7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
尚未招募
入组人数
150
试验地点
1
主要终点
Patient Activation Measure Scale Score

研究概览

简要总结

More than 40% of patients with gastroesophageal reflux disease (GERD) experience uncontrolled, chronic symptoms. This proposal aims to improve symptom control for patients with GERD, by developing a mobile health (mHealth) Question Prompt List (QPL) intervention that helps patient ask questions with his/her physician about GERD. The first aim is to gather feedback about daily challenges of living with GERD. The second aim is to gather feedback on the prototype app. The third (primary) aim of this project is to develop the mHealth application and measure differences in patient activation when used compared to standard of care.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •clinical diagnosis of GERD
  • •GerdQ score of >=8
  • •documented PPI use for GERD
  • •internet access at home or computer/mobile device
  • •ability to provide written or e-consent.

排除标准

  • •Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry)
  • •non-English speaking patients

研究组 & 干预措施

Focus Group (Aim 1)

No Intervention

Participants give feedback about day-to-day challenges with GERD.

Focus Group (Aim 2)

No Intervention

Participants give feedback about mobile health app prototype

mHealth app (Aim 3)

Experimental

Participants will be exposed to an app-based question prompt list with gamification features to promote medication adherence as part of their communication with their health provider.

干预措施: Use of mHealth Question Prompt List app (Behavioral)

Standard of care (Aim 3)

No Intervention

Participants will be exposed to standard of care communication with their health provider (no mHealth app).

结局指标

主要结局

Patient Activation Measure Scale Score

时间窗: month 6

Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.

Patient Activation Measure Scale Score

时间窗: month 3

Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.

次要结局

  • 12-item Short Form Survey(months 3 and 6)
  • Pill Count(months 3 and 6)
  • Gerd-Q(months 3 and 6)

研究者

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

Afrin Kamal

Clinical Assistant Professor of Medicine

Stanford University

研究点 (1)

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