NCT05883072

Brief Summary

We plan to explore the usability of Generative AI-Chatbot for Diabetic Patient

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jan 2023Dec 2026

Study Start

First participant enrolled

January 5, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

March 9, 2023

Last Update Submit

June 2, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Usability of the Chatbot for diabetic patient

    To assess the usability of the Chatbot, we will employ the mHealth App Usability Questionnaire (MAUQ) to gather feedback from patients following their interaction. Our study will utilize Table 4 of this questionnaire, which consists of three sections: ease of use, interface, and satisfaction and usefulness. Specifically, we will focus our evaluation on 10 out of the 18 questions presented in this table. The selected questions are S1, S2, S6, S7, S9, S11, S12, S13, S14, and S18. Patients will provide their responses on a scale of 1 to 5, where "1" indicates very poor and "5" denotes very good.

    One time

  • Internet Speed

    Minimum downloading speed of internet will be measured during the chat. This will be recorded in Mega bits per second.

    One time

Secondary Outcomes (1)

  • Analyzing Chat response generated by AI Chatbot

    One time

Study Arms (1)

Intervention

Patients will be provided access to Chatbot to enquire their querries regarding diabetic complications.

Behavioral: Exploring AI-Chatbot

Interventions

All participants will be provided access to AI-Chatbot and will be asked to enquire their daily life problems related to diabetes. They will also be asked to review the replies of the Chatbot after their interaction.

Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People affected with diabetes in Pakistan

You may qualify if:

  • Present physically in Pakistan
  • Adults (18 years or older)
  • Diabetic Patient

You may not qualify if:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CDLE, PCSIR Lbas Complex

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic RetinopathyDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Ghulam Mustafa

    Pakistan Council of Scientific and Industrial Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

May 31, 2023

Study Start

January 5, 2023

Primary Completion

December 30, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

June 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Locations