- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05883072
Exploring the Effectiveness of AI Generative Models for Diabetic Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
Diabetes is rapidly spreading, affecting a significant number of adults, with a staggering total of 537 million diabetic individuals. This condition gives rise to various complications that can lead to diabetic retinopathy, foot ulcers, cardiac problems, and kidney damage. However, many of these complications can be mitigated by providing patients with accurate information concerning their diet, stress management, and weight control.
The recent advancements in Generative Artificial Intelligence-based chatbots have demonstrated their efficacy as intelligent assistants across various aspects of human life. In this study, we aim to assess the effectiveness of these Language Models in assisting patients. Our research plan entails the interaction between patients and chatbots like ChatGPT, both with and without human support, followed by evaluations of these interactions by specialists. Additionally, we will gather feedback from patients regarding their experiences and perceptions of the chatbot interactions.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ghulam Mustafa
- Phone Number: +923322340395
- Email: mustafabme@gmail.com
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Recruiting
- CDLE, PCSIR Lbas Complex
-
Contact:
- Ghulam Mustafa
- Email: mustafabme@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Present physically in Pakistan
- Adults (18 years or older)
- Diabetic Patient
Exclusion Criteria:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intervention
Patients will be provided access to Chatbot to enquire their querries regarding diabetic complications.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability of the Chatbot for diabetic patient
Time Frame: One time
|
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
Time Frame: One time
|
Minimum downloading speed of internet will be measured during the chat.
This will be recorded in Mega bits per second.
|
One time
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analyzing Chat response generated by AI Chatbot
Time Frame: One time
|
Likert scale will be used to evaluate the chat response of Chatbot. The following parameters will be evaluated by the specialists for each response namely Clear, Complete and Correct. Clear and Completeness will be evaluated on a range of 1-5, where 1 means poor quality and 5 means very good quality response. The correctness of each response will be further analyzed as Safe and latest. It will be evaluated in binary terms i.e. Yes or No. |
One time
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ghulam Mustafa, Pakistan Council of Scientific and Industrial Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI Chatbot Evaluation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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