- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06079450
Effect of Artıfıcıal Intellıgence Based Mobıle Vırtual Assıstant (AI)
Effect of Artıfıcıal Intellıgence Based Mobıle Vırtual Assıstant Developed For Indıvıduals Wıth Dıabetes On Cost Effıcıency, Hospıtal Admıssıon Rate, Self-Care And Hypoglycemıa
Aim: This study was conducted experimentally to examine the effect of artificial intelligence-based mobile virtual assistant developed for individuals with diabetes on cost, hospitalization rate, self-care and hypoglycemia.
Methods: The research is multi-stage and designed as three stages in itself. According to this; development of the mobile application in the first and second stages and adding artificial intelligence to the application as a project; In the third stage, it was planned to examine the effect of the application on the variables and scales. The data of the study were collected between June 2022 and June 2023 in the Endocrinology Polyclinic of two private hospitals in Izmir and a diabetes association where individuals with diabetes were registered. Power 0.80 was determined by using NCSS PAS statistical software from the population of the research; The minimum number of samples to be included in the study was calculated as n:122 and they were divided into two as intervention and control groups by randomization. The research sample was carried out as intervention (n:60) and control (n:60) lastly due to death and cost. Five data collection tools were used, namely "Individual Introduction Form", "Diabetes Self-Care Scale", "Hypoglycemia Confidence Scale", "Mobile Application Opinion Form" and "Cost Table". An artificial intelligence-based mobile virtual assistant application was applied to the individuals with diabetes in the intervention group, and the data were collected three times, at the 0th, 6th and 12th months, and the costs were recorded. The standard outpatient trainings, which are currently applied, continued to be given to individuals with diabetes in the control group, the data were collected twice, at the beginning (0. month) and 12. months, and the costs were recorded. In the evaluation of the data, number, percentage, arithmetic mean, standard deviation, minimum and maximum median were calculated. Among the variables, chi-square, Kruskal Wallis, Mann Whitney U test and t test were used.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Izmır, Turkey, 35620
- Izmir Katip Çelebi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- The patient has a perception disorder and psychiatric disorder that prevents communication,
- Desire to leave the research,
- His death during the research,
- Being pregnant,
- Individuals with severe retinopathy and neuropathy that prevent smartphone use were excluded from the study.
Description
Inclusion Criteria:
- Having been diagnosed with Type 1 and Type 2 diabetes at least six months ago, according to the criteria of the American Diabetes Association (ADA),
- Using insulin for at least six months,
- Being between the ages of 18- 65,
- Being able to read and write and speak Turkish,
- Having an Android phone and being able to use mobile applications,
- To volunteer to participate in the study.
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
experimental group
Artificial intelligence-based mobile application initiative was implemented for diabetes patients
|
Artificial intelligence-based mobile application developed by me that includes diabetes education for individuals with diabetes.
|
|
control group
no intervention was applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes Self-Care Scale
Time Frame: 12 months
|
The score consists of 35 items and is a 4-point Likert type, the lowest acceptable score is 92 and the highest score is 140.
As the score increases, self-care increases
|
12 months
|
|
Hypoglycemic Confidence Scale
Time Frame: 12 months
|
The scale consists of 9 items and is a 4-point Likert type.
There is no cut-off value, the average score is used.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hospitalization rate
Time Frame: 12 months
|
percentage
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- ikçü (Other Identifier: Katip Çelebi University)
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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