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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Mohamed Fakhry Ahmed Salem, PhD
- Telefoonnummer: 01286038014
- E-mail: Mohamed.Fakhry@alexu.edu.eg
Studie Locaties
-
-
Alexandria Governorate
-
Alexandria, Alexandria Governorate, Egypte, 2500
- Faculty of Nursing, Alexandria University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
|
Geen tussenkomst: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Self-Efficacy for Diabetes Management
Tijdsspanne: Baseline, week 8, week 14 and week 20
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Self-Care Behaviors
Tijdsspanne: Baseline, week 8, week 14 and week 20
|
Summary of Diabetes Self-Care Activities (SDSCA), Arabic version; higher scores indicate more frequent self-care. |
Baseline, week 8, week 14 and week 20
|
|
Change in Self-Reported Medication Adherence
Tijdsspanne: Baseline, week 8, week 14 and week 20
|
Self-report medication adherence scale, Arabic version (instrument to be confirmed before data collection). |
Baseline, week 8, week 14 and week 20
|
|
Change in Disease Knowledge
Tijdsspanne: Baseline, week 8, week 14 and week 20
|
Diabetes Knowledge Questionnaire (DKQ-24), Arabic version; higher scores indicate greater knowledge. |
Baseline, week 8, week 14 and week 20
|
|
Participant Experiences With the App
Tijdsspanne: After the week 20 assessment
|
Semi-structured in-depth interviews on experiences, barriers and facilitators of continued use. |
After the week 20 assessment
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mohamed Fakhry Ahmed Salem, Alexandria University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AICHATBOT-T2DM-RCT-2026
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .