NCT06079450

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

August 10, 2023

Last Update Submit

October 5, 2023

Conditions

Keywords

Diabetesmobile applicationartificial intelligenceself-carehospitalizationcost

Outcome Measures

Primary Outcomes (2)

  • Diabetes Self-Care Scale

    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

    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 Outcomes (1)

  • hospitalization rate

    12 months

Study Arms (2)

experimental group

Artificial intelligence-based mobile application initiative was implemented for diabetes patients

Other: artificial intelligence based mobile application

control group

no intervention was applied

Interventions

Artificial intelligence-based mobile application developed by me that includes diabetes education for individuals with diabetes.

experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Izmır, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Internal Medicine Nursing

Study Record Dates

First Submitted

August 10, 2023

First Posted

October 12, 2023

Study Start

June 10, 2022

Primary Completion

January 10, 2023

Study Completion

August 7, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations