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Completed

NCT Number: NCT05787067

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

This study aims to investigate the effect of health belief model-based mobile online training applied to patients with diabetes on insulin therapy.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk Universty

Erzurum, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Belief Model-Based Mobile Online Training

Behavioral

Health Belief Model-Based Mobile Online Training

Primary outcomes

  1. Evaluation of Participants' Metabolic Variables (Body Mass Index (BMI)

    Time frame: Three months

    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.

  2. Evaluation of Participants' Metabolic Variables ( Fasting Blood Sugar (FBS))

    Time frame: Three months

    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.

  3. Evaluation of Participants' Metabolic Variables (High Density Lipoprotein (HDL))

    Time frame: Three months

    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.

  4. Evaluation of Participants' Metabolic Variables (Low Density Lipoprotein (LDL))

    Time frame: Three months

    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.

  5. Evaluation of Participants' Metabolic Variables (HgA1C)

    Time frame: Three months

    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.

  6. Evaluation of Participants' Self-Management of Insulin Therapy

    Time frame: Three months

    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.

  7. Evaluation of Participants' Health Belief Attitudes and Behaviors

    Time frame: Three months

    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.

  8. Evaluation of Participants' Insulin Injection Administration Skill Levels

    Time frame: Three months

    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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effect of Health Belief Model-Based Mobile Online Training Applied to Patients With Diabetes on Insulin Therapy

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 28, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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