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The Effect of Mobile Online Training Applied to Patients With Diabetes on Insulin Therapy

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Health Belief Model-Based Mobile Online Training
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes, web-based mobile training, insulin therapy, insulin self-management, insulin injection skill, health belief model

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Research Inclusion Criteria Type 1 DM Type 2 DM (Diagnosed at least six months ago) Patients receiving insulin therapy Patients in the 18-65 age group Literate patients Patients, or patients with a relative, who has an electronic device such as a smartphone, computer, etc. that can connect to the Internet. Patients who have no psychiatric illness or communication barrier (visual, auditory, and speech disability) Individuals who agreed to participate in the research. Research Exclusion Criteria Patients who receive treatment with oral anti-DM only Patients who use an insulin pump Patients who quit the training. Patients who had a change in treatment Patients who traveled to a place that cannot provide an Internet connection

Sites / Locations

  • Atatürk Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

control group

Arm Description

The web-based "Insulin Guide" mobile application prepared by the researcher was installed on the phones of the intervention group participants. They were asked to use this application for three months, at least three hours a week. Participants were followed up through the application. Participants who did not use the application were informed by SMS or phone and asked to use the application. Participants who did not use the application were excluded from the study. At the end of three months, the participants in the intervention groups were invited to the Endocrinology and Metabolic Diseases Outpatient Clinic for a post-test. Both groups were asked to practice again on the insulin injection model. Whether the application was correct, incomplete, or incorrect was recorded on the observation form by the diabetes nurse.

Control group participants were invited to the Endocrinology and Metabolic Diseases Polyclinic for the pre-test. They were asked to administer insulin injections using an insulin injection model. Whether the application was correct, incomplete or incorrect was recorded in the observation form by the diabetes nurse. No intervention was made to the participants. At the end of three months, the participants in the control group were invited to the Endocrinology and Metabolic Diseases Polyclinic for the final test. And they were asked to repeat the insulin injection model. Whether the application was correct, incomplete or incorrect was recorded in the observation form by the diabetes nurse.

Outcomes

Primary Outcome Measures

Evaluation of Participants' Metabolic Variables (Body Mass Index (BMI)
The metabolic variables (Body Mass Index) of the individuals in the experimental and control groups were taken from hospital records and evaluated. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the BMI values of individuals in both the experimental and control groups were re-evaluated from the hospital records.
Evaluation of Participants' Metabolic Variables ( Fasting Blood Sugar (FBS))
The metabolic variables (Fasting Blood Sugar) of the individuals in the experimental and control groups were evaluated by taking them from the hospital records. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the FBC values of individuals in both the experimental and control groups were re-evaluated from the hospital records.
Evaluation of Participants' Metabolic Variables (High Density Lipoprotein (HDL))
The metabolic variables (High Density Lipoprotein) of the individuals in the experimental and control groups were evaluated from hospital records. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, HDL values of individuals in both the experimental and control groups were re-evaluated from hospital records.
Evaluation of Participants' Metabolic Variables (Low Density Lipoprotein (LDL))
The metabolic variables (Low Density Lipoprotein) of the individuals in the experimental and control groups were evaluated from hospital records. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the LDL values of individuals in both the experimental and control groups were re-evaluated from the hospital records.
Evaluation of Participants' Metabolic Variables (HgA1C)
HgA1C, one of the metabolic variables of the individuals in the experimental and control groups, was taken from hospital records and evaluated. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, HgA1C values of individuals in both the experimental and control groups were re-evaluated from hospital records.
Evaluation of Participants' Self-Management of Insulin Therapy
Insulin therapy self-management of individuals in the experimental and control groups was evaluated with the "Insulin Therapy Self-Management Scale". With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the insulin therapy self-management of individuals in both the experimental and control groups was re-evaluated with the "Insulin Therapy Self-Management Scale". "Insulin Therapy Self-Management Scale" is a scale used to evaluate the knowledge-skill levels and positive-negative attitudes of individuals with diabetes towards insulin therapy. The increase in the scores obtained in all sub-dimensions indicates that the self-management levels in that dimension increase.
Evaluation of Participants' Health Belief Attitudes and Behaviors
The health belief attitudes and behaviors of the individuals in the experimental and control groups were evaluated with the "Health Belief Model Scale". With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the health belief attitudes and behaviors of individuals in both the experimental and control groups were re-evaluated using the "Health Belief Model Scale". The scale used to evaluate the health belief attitudes and health behaviors of individuals with diabetes consists of a total of 33 items. If the score obtained from the scale is four and above, it indicates positive health belief, and if it is less than four, it indicates negative health belief.
Evaluation of Participants' Insulin Injection Administration Skill Levels
The insulin injection application skill levels of the individuals in the experimental and control groups were evaluated with the "Insulin Injection Skill Observation Form" prepared by the researcher in line with the literature. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the insulin injection skill levels of both the experimental and control groups were re-evaluated with the "Insulin Injection Skill Observation Form". "Insulin Injection Skill Observation Form" was developed with the aim of objectively evaluating insulin injection application performance. It consists of 21 items in total. If the patient did the application wrong, he/she gets 0 points, if he/she did it incompletely, he/she gets 1 point, and if he/she did it completely, he/she gets 2 points. The higher the average score, the higher will be their insulin injection skill level.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2023
Last Updated
March 24, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05787067
Brief Title
The Effect of Mobile Online Training Applied to Patients With Diabetes on Insulin Therapy
Official Title
The Effect of Health Belief Model-Based Mobile Online Training Applied to Patients With Diabetes on Insulin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 30, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to investigate the effect of health belief model-based mobile online training applied to patients with diabetes on insulin therapy.
Detailed Description
Intervention and control group participants were invited to the Endocrinology and Metabolic Diseases Outpatient Clinic for a pre-test. n addition, each group was given insulin injection practice training using an insulin injection model. Whether the application was correct, incomplete, or incorrect was recorded on the observation form by the diabetes nurse. The web-based "Insulin Guide" mobile application prepared by the researcher was installed on the phones of the intervention group participants. They were asked to use this application for three months, at least three hours a week. Participants were followed up through the application. Participants who did not use the application were informed by SMS or phone and asked to use the application. Participants who did not use the application were excluded from the study. No intervention was made for the control group participants. At the end of three months, the participants in the intervention and control groups were invited to the Endocrinology and Metabolic Diseases Outpatient Clinic for a post-test. Both groups were asked to practice again on the insulin injection model. Whether the application was correct, incomplete, or incorrect was recorded on the observation form by the diabetes nurse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords
Diabetes, web-based mobile training, insulin therapy, insulin self-management, insulin injection skill, health belief model

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The web-based "Insulin Guide" mobile application prepared by the researcher was installed on the phones of the intervention group participants. They were asked to use this application for three months, at least three hours a week. Participants were followed up through the application. Participants who did not use the application were informed by SMS or phone and asked to use the application. Participants who did not use the application were excluded from the study. At the end of three months, the participants in the intervention groups were invited to the Endocrinology and Metabolic Diseases Outpatient Clinic for a post-test. Both groups were asked to practice again on the insulin injection model. Whether the application was correct, incomplete, or incorrect was recorded on the observation form by the diabetes nurse.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Control group participants were invited to the Endocrinology and Metabolic Diseases Polyclinic for the pre-test. They were asked to administer insulin injections using an insulin injection model. Whether the application was correct, incomplete or incorrect was recorded in the observation form by the diabetes nurse. No intervention was made to the participants. At the end of three months, the participants in the control group were invited to the Endocrinology and Metabolic Diseases Polyclinic for the final test. And they were asked to repeat the insulin injection model. Whether the application was correct, incomplete or incorrect was recorded in the observation form by the diabetes nurse.
Intervention Type
Behavioral
Intervention Name(s)
Health Belief Model-Based Mobile Online Training
Intervention Description
Health Belief Model-Based Mobile Online Training
Primary Outcome Measure Information:
Title
Evaluation of Participants' Metabolic Variables (Body Mass Index (BMI)
Description
The metabolic variables (Body Mass Index) of the individuals in the experimental and control groups were taken from hospital records and evaluated. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the BMI values of individuals in both the experimental and control groups were re-evaluated from the hospital records.
Time Frame
Three months
Title
Evaluation of Participants' Metabolic Variables ( Fasting Blood Sugar (FBS))
Description
The metabolic variables (Fasting Blood Sugar) of the individuals in the experimental and control groups were evaluated by taking them from the hospital records. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the FBC values of individuals in both the experimental and control groups were re-evaluated from the hospital records.
Time Frame
Three months
Title
Evaluation of Participants' Metabolic Variables (High Density Lipoprotein (HDL))
Description
The metabolic variables (High Density Lipoprotein) of the individuals in the experimental and control groups were evaluated from hospital records. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, HDL values of individuals in both the experimental and control groups were re-evaluated from hospital records.
Time Frame
Three months
Title
Evaluation of Participants' Metabolic Variables (Low Density Lipoprotein (LDL))
Description
The metabolic variables (Low Density Lipoprotein) of the individuals in the experimental and control groups were evaluated from hospital records. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the LDL values of individuals in both the experimental and control groups were re-evaluated from the hospital records.
Time Frame
Three months
Title
Evaluation of Participants' Metabolic Variables (HgA1C)
Description
HgA1C, one of the metabolic variables of the individuals in the experimental and control groups, was taken from hospital records and evaluated. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, HgA1C values of individuals in both the experimental and control groups were re-evaluated from hospital records.
Time Frame
Three months
Title
Evaluation of Participants' Self-Management of Insulin Therapy
Description
Insulin therapy self-management of individuals in the experimental and control groups was evaluated with the "Insulin Therapy Self-Management Scale". With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the insulin therapy self-management of individuals in both the experimental and control groups was re-evaluated with the "Insulin Therapy Self-Management Scale". "Insulin Therapy Self-Management Scale" is a scale used to evaluate the knowledge-skill levels and positive-negative attitudes of individuals with diabetes towards insulin therapy. The increase in the scores obtained in all sub-dimensions indicates that the self-management levels in that dimension increase.
Time Frame
Three months
Title
Evaluation of Participants' Health Belief Attitudes and Behaviors
Description
The health belief attitudes and behaviors of the individuals in the experimental and control groups were evaluated with the "Health Belief Model Scale". With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the health belief attitudes and behaviors of individuals in both the experimental and control groups were re-evaluated using the "Health Belief Model Scale". The scale used to evaluate the health belief attitudes and health behaviors of individuals with diabetes consists of a total of 33 items. If the score obtained from the scale is four and above, it indicates positive health belief, and if it is less than four, it indicates negative health belief.
Time Frame
Three months
Title
Evaluation of Participants' Insulin Injection Administration Skill Levels
Description
The insulin injection application skill levels of the individuals in the experimental and control groups were evaluated with the "Insulin Injection Skill Observation Form" prepared by the researcher in line with the literature. With the developed web-based mobile "Insulin Guide" application, the experimental group was trained for three months. No intervention was made in the control group. Three months later, the insulin injection skill levels of both the experimental and control groups were re-evaluated with the "Insulin Injection Skill Observation Form". "Insulin Injection Skill Observation Form" was developed with the aim of objectively evaluating insulin injection application performance. It consists of 21 items in total. If the patient did the application wrong, he/she gets 0 points, if he/she did it incompletely, he/she gets 1 point, and if he/she did it completely, he/she gets 2 points. The higher the average score, the higher will be their insulin injection skill level.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Research Inclusion Criteria Type 1 DM Type 2 DM (Diagnosed at least six months ago) Patients receiving insulin therapy Patients in the 18-65 age group Literate patients Patients, or patients with a relative, who has an electronic device such as a smartphone, computer, etc. that can connect to the Internet. Patients who have no psychiatric illness or communication barrier (visual, auditory, and speech disability) Individuals who agreed to participate in the research. Research Exclusion Criteria Patients who receive treatment with oral anti-DM only Patients who use an insulin pump Patients who quit the training. Patients who had a change in treatment Patients who traveled to a place that cannot provide an Internet connection
Facility Information:
Facility Name
Atatürk Universty
City
Erzurum
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Mobile Online Training Applied to Patients With Diabetes on Insulin Therapy

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