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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mohamed Fakhry Ahmed Salem, PhD
- 전화번호: 01286038014
- 이메일: Mohamed.Fakhry@alexu.edu.eg
연구 장소
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Alexandria Governorate
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Alexandria, Alexandria Governorate, 이집트, 2500
- Faculty of Nursing, Alexandria University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Self-Efficacy for Diabetes Management
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Self-Care Behaviors
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Mohamed Fakhry Ahmed Salem, Alexandria University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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