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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mohamed Fakhry Ahmed Salem, PhD
- Numero di telefono: 01286038014
- Email: Mohamed.Fakhry@alexu.edu.eg
Luoghi di studio
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Alexandria Governorate
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Alexandria, Alexandria Governorate, Egitto, 2500
- Faculty of Nursing, Alexandria University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Self-Efficacy for Diabetes Management
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Self-Care Behaviors
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mohamed Fakhry Ahmed Salem, Alexandria University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AICHATBOT-T2DM-RCT-2026
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