AI Chatbot Mobile App for Self-Management in Type 2 Diabetes (CHAT-T2DM)
Effect of an AI-Powered Chatbot-Integrated Mobile Application on Self-Efficacy, Self-Care Behaviors, and Medication Adherence Among Patients With Type 2 Diabetes Mellitus: A Mixed-Methods Randomized Controlled Trial
Type 2 diabetes needs daily self-management, but most of it happens outside the clinic, where patients get little continuous support. Earlier studies of mobile applications and chatbots were mostly short, and few tested whether benefits last after use stops. This randomized controlled trial will test an Arabic-language mobile application with an artificial intelligence chatbot for adults with type 2 diabetes attending outpatient diabetes clinics in Egypt. The application offers diabetes education, reminders, glucose and activity logging, goal setting, prompts that adapt when use declines, a diabetes distress check, and nurse oversight. A total of 120 adults will be randomly assigned equally to usual care plus the application for 8 weeks, or to usual care with an educational leaflet. Outcome assessors will not know group assignment. The main outcome is self-efficacy. Other outcomes are self-care behaviors, medication adherence, disease knowledge, random blood glucose, diabetes distress, and application use, measured at the start, at 8 weeks, and 6 and 12 weeks after the intervention ends. About 20 intervention participants will then be interviewed about their experiences and what helps or hinders continued use, and these findings will be combined with the trial results.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mohamed Fakhry Ahmed Salem, PhD
- 电话号码：01286038014
- 邮箱：Mohamed.Fakhry@alexu.edu.eg
学习地点
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Alexandria Governorate
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Alexandria、Alexandria Governorate、埃及、2500
- Faculty of Nursing, Alexandria University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults aged 18 years or older with a diagnosis of type 2 diabetes for at least 6 months
- Using a smartphone (Android or iOS) with internet access, or willing to use a study-provided basic training to do so
- Able to read and communicate in Arabic
- On a stable antidiabetic regimen for at least 3 months
- Willing to provide written informed consent
Exclusion Criteria:
- Type 1 or gestational diabetes
- Severe cognitive impairment, psychiatric illness, or visual/hearing impairment preventing app use
- Acute diabetic complications or unstable medical conditions at enrollment
- Participation in another diabetes self-management trial
- Healthcare workers (to limit contamination)
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：AI Chatbot App Plus Usual Care
Usual care (routine clinic follow-up and standard diabetes education) plus the AI chatbot-integrated mobile application for 8 weeks. |
Eight-week use of an Arabic-language mobile application with an AI conversational chatbot that answers diabetes questions and delivers structured education on diet, activity, glucose monitoring, medication use and foot care. Includes personalized medication and self-monitoring reminders; glucose and activity logging with feedback; goal setting, progress summaries and positive reinforcement; adaptive engagement prompts and content that change when usage declines; a diabetes distress screening module with escalation to the study nurse for flagged participants; and a nurse dashboard for monitoring usage and responding to safety alerts. The chatbot does not give insulin or drug dose changes and redirects urgent symptoms to emergency care. Participants receive app installation and a short orientation. |
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无干预：Usual Care With Educational Leaflet
Usual care (routine clinic follow-up and standard diabetes education) with an educational leaflet. Control participants will be offered the application after the final assessment. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Self-Efficacy for Diabetes Management
大体时间：Baseline, week 8, week 14 and week 20
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Self-efficacy in managing diabetes measured with the Diabetes Self-Efficacy Scale (validated Arabic version); higher scores indicate greater self-efficacy. Group comparison of change from baseline, adjusted for baseline score. |
Baseline, week 8, week 14 and week 20
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Self-Care Behaviors
大体时间：Baseline, week 8, week 14 and week 20
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Summary of Diabetes Self-Care Activities (SDSCA), Arabic version; higher scores indicate more frequent self-care. |
Baseline, week 8, week 14 and week 20
|
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Change in Self-Reported Medication Adherence
大体时间：Baseline, week 8, week 14 and week 20
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Self-report medication adherence scale, Arabic version (instrument to be confirmed before data collection). |
Baseline, week 8, week 14 and week 20
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Change in Disease Knowledge
大体时间：Baseline, week 8, week 14 and week 20
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Diabetes Knowledge Questionnaire (DKQ-24), Arabic version; higher scores indicate greater knowledge. |
Baseline, week 8, week 14 and week 20
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Participant Experiences With the App
大体时间：After the week 20 assessment
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Semi-structured in-depth interviews on experiences, barriers and facilitators of continued use. |
After the week 20 assessment
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合作者和调查者
调查人员
- 首席研究员：Mohamed Fakhry Ahmed Salem、Alexandria University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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