Diabetes Mellitus, Type 1NCT05787067
The Effect of Mobile Online Training Applied to Patients With Diabetes on Insulin Therapy
A study testing Health Belief Model-Based Mobile Online Training in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of health belief model-based mobile online training applied to patients with diabetes on insulin therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Health Belief Model-Based Mobile Online Training
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2021to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Health Belief Model-Based 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.
Read the 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.
- Being tested
- Health Belief Model-Based Mobile Online Training
- Keywords
- Diabetes, web-based mobile training, insulin therapy, insulin self-management, insulin injection skill, health belief model
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Belief Model-Based Mobile Online TrainingBehavioural
Health Belief Model-Based Mobile Online Training
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Health Belief Model-Based Mobile Online Training |
| control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start30 Dec 2021
- Primary completion30 Dec 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Ceren DEMİREL YILDIZ, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787067
- Sponsor's protocol ID
- BÜŞRA TEZ
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Belief Model-Based Mobile Online Training Applied to Patients With Diabetes on Insulin Therapy
- ClinicalTrials.gov ID
- NCT05787067
- Acronym / sponsor ID
- BÜŞRA TEZ
- Keywords
- Diabetes, web-based mobile training, insulin therapy, insulin self-management, insulin injection skill, health belief model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Health Belief Model-Based Mobile Online TrainingThe 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 | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Belief Model-Based Mobile Online TrainingHealth Belief Model-Based Mobile Online Training | Behavioural | Intervention group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Belief Model-Based Mobile Online Training in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Participants' Metabolic Variables (Body Mass Index (BMI) (time frame: Three months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.