Diabetes Type 2NCT05266742
Investigation of the Effect of Web-based Education on Self-Care Management and Family Support in Women With Type 2 Diabetes
A study testing web based education in people with Diabetes Type 2, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This is a quasi-experimental study that was carried out to examine the effect of the web-based education given to female individuals using insulin with Type 2 diabetes on self-care management and family support. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- web based education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2019to 15 Aug 2020
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with Type 2 diabetes at least a year ago
- using insulin
- able to use computers and smartphones
Who cannot join
- Not having been diagnosed with diabetes
Trial locations and contacts
1 site in 1 country.
About this study
This is a quasi-experimental study that was carried out to examine the effect of the web-based education given to female individuals using insulin with Type 2 diabetes on self-care management and family support.
Methods A randomized controlled trial using a sample (N=66) of women with type 2 diabetes who admitted to the hospital's outpatient clinic in 2020. The intervention group received web-based education for six months. Socio-demographic data, metabolic values, "Diabetes Self-Care Scale" and "Family Support and Conflict Scale in Type 2 Diabetes" were used.
Read the detailed description
Methods This quasi-experimental study was conducted in Ankara, Turkey, 2020. Sixty six patients were selected using convenient sampling and divided equally into two control and intervention groups based on random allocation. Web-based education was provided to the intervention group for six months. Data were collected before, at the third month of the intervention, and at the end of the intervention using "Patient Identification Form", "Metabolic Control Variables Form", "Diabetes Self-Care Scale" and "Family Support and Conflict Scale in Type 2 Diabetes" forms. All the patients were female individuals diagnosed with Type 2 diabetes at least a year ago, using insulin between the ages of 18 to 65 years old, who applied to the internal medicine and endocrine outpatient clinic of a training and research hospital in Ankara. Patients had no communication barriers, and they were able to use computers and smartphones and volunteer for this study. No consultancy training was given to the control group by the researcher. They only received routine education in the hospital.
Data Collection Tools Data is collected using "Patient Identification Form", "Metabolic Control Variables Form", "Diabetes Self-Care Scale" and "Family Support and Conflict Scale in Type 2 Diabetes" forms.
Patient Identification Form Patient Identification Form was created for this study by scanning the literature. In this form, there were 12 questions in total. The questions included the first letters of the name and surname for coding purposes. There were questions about the age, marital status, employment status, educational status, smoking, alcohol and snacking habits, regular insulin use, blood glucose measurement, physical activity, dietary compliance, and previous educations about diabetes.
Metabolic Control Variables Form Metabolic Control Variables Form was created for this study by scanning the literature. It had questions regarding the disease of the individuals. The questions were about fasting blood glucose, HbA1c, LDL, HDL, total cholesterol, triglycerides, weight, height, and body mass index.
Diabetes Self-Care Scale Diabetes Self-Care Scale is a survey. Diabetes Self-Care Scale was developed by Lee and Fisher in 2005. It aims to evaluate the self-care activities of patients with type 2 diabetes. This scale was adapted and translated to Turkish by Karakurt and Kaşıkçı in 2008. The options of the scale were changed to "Never (1)" "Sometimes (2)" "Frequently (3)" and "Always (4)". It has been stated that patients who score points more than 66% of the scale total points are assumed at a level to meet their self-care. Based on the 4-point Likert type, the maximum score of the scale was 140 points. As the score increases, the self-care activities of the patients increase positively. Diabetes Self-Care Scale contains 35 items. The scale does not have sub-dimensions and inverse expressions. These items aim to get information about eating on time, exercising, measuring and recording blood sugar, using oral antidiabetics and insulin as recommended, visiting a doctor for checking blood sugar, foot care, personal hygiene practices, diabetes, and its complications. While the Cronbach Alpha value of the scale developed by Lee and Fisher was determined to be 0.80, the total Cronbach Alpha coefficient of the scale in Karakurt's research was determined as 0.81.
Family Support and Conflict Scale in Type 2 Diabetes The Family Support and Conflict Scale in Type 2 Diabetes is a survey. The Family Support and Conflict Scale in Type 2 Diabetes was prepared by Charlotte Paddison in Japan in 2010 for individuals with type 2 diabetes. It consists of informative questions about the support status of the family and conflicts with the family. The scale was adapted to Turkish by Sofulu and Avdal in 2015 and the Cronbach Alpha coefficient of the scale is 0.740. DFSC has two sub-dimensions being 'Family Support' and 'Family Conflict'. The highest score obtained from the sub-dimensions was 50 and the lowest score was 10. As the subscale scores increase, the level of support increases. As the family conflict sub-dimension score decreases, the family conflict increase. The answers in the scale are 5-point Likert type and are classified as strongly agree, agree, undecided, disagree, strongly disagree. The scale contains 10 items in total. The items aim to get information to measure the family's attitude towards the diet, exercise, medications, and mental state of the diabetic.
Website An educative website was created for our study. The content of the website was accessible from "www.diyabet.mumcu.net" and the content of the website was brought together by scanning the literature. The content text was quoted from publicly available information and guides as ADA and IDF. The pictures on the website were obtained from license-free sources. The website also included a training video that was prepared by the researcher. The website was developed by using Microsoft Asp.NET MVC technology and it was designed responsively for ease of use. The website could be accessed from computers, tablets, and smartphones. Expert opinions were obtained using the DISCERN Measurement Tool to evaluate the reliability and quality of the training material. A username and a password were provided separately for each of the 33 individuals in the intervention group. In addition to the user content, the website had a separate management panel that was only used by the researcher. Using this admin panel, the researcher could see the pages that the participants in the intervention group accessed on the website, and the page visit times were available in logs. The content of the website is divided into training modules. These modules were published to the users sequentially during six months period by allowing access to a new module a month. A reminder message was sent twice a week to the user regarding the subject of the training module.
Application of Data Collection Tools Patient identification form, metabolic control variables form, Diabetes Self-Care Scale and Family Support and Conflict Scale in Type 2 Diabetes were administered face-to-face with interviews to the individuals included in the study when they came to their outpatient clinic appointments. In the third month of the study, the laboratory results of the hospital system were obtained and the form of metabolic control variables was recorded. It has been obtained from the routine laboratory results that were checked every three months upon the doctor's request. No blood was taken from individuals by the researcher. Web-based education was provided to the intervention group for six months. The metabolic control variables form, Diabetes Self-Care Scale and Family Support and Conflict Scale in Type 2 Diabetes were administered by the researcher using face-to-face interviews, e-mails, and mobile phone calls to the intervention and control groups based on their request at the end of the study.
- Conditions
- Diabetes Type 2
- Being tested
- web based education
- Keywords
- Diabetes Mellitus, nurse, self care, web based education, family
- Medical subject headings
- 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.
web based educationOther
An educative website was created for our study. The content of the website was accessible from "www.diyabet.mumcu.net" and the content of the website was brought together by scanning the literature. The content text was quoted from publicly available information and guides as ADA and IDF.
| Study group | Role | What they receive |
|---|---|---|
| END | Experimental | Use of web based education Receives: Other: web based education |
| END free | No intervention | patient witout of web based education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Self-Care Scale
Diabetes Self-Care Scale Diabetes Self-Care Scale is a survey. It has been stated that patients who score points more than 66% of the scale total points are assumed at a level to meet their self-care. Based on the 4-point Likert type, the maximum score of the scale was 140 points. As the score increases, the self-care activities of the patients increase positively. It contains 35 items. These items aim to get information about eating on time, exercising, measuring and recording blood sugar, using oral antidiabetics and insulin as recommended, visiting a doctor for checking blood sugar, foot care, personal hygiene practices, diabetes, and its complications.
Measured: a day before the education
Family Support and Conflict Scale in Type 2 Diabetes
The Family Support and Conflict Scale in Type 2 Diabetes is a survey. DFSC has two sub-dimensions being 'Family Support' and 'Family Conflict'. The highest score obtained from the sub-dimensions was 50 and the lowest score was 10. As the subscale scores increase, the level of support increases. As the family conflict sub-dimension score decreases, the family conflict increase. The answers in the scale are 5-point Likert type and are classified as strongly agree, agree, undecided, disagree, strongly disagree. The scale contains 10 items in total. The items aim to get information to measure the family's attitude towards the diet, exercise, medications, and mental state of the diabetic.
Measured: a day before the education
Metabolic Control Variables Form
Metabolic Control Variables Form is created for this study by scanning the literature. It has questions regarding the disease of the individuals. The questions are about fasting blood glucose, HbA1c, LDL, HDL, total cholesterol, triglycerides, weight, height, and body mass index.
Measured: a day before the education
Patient Identification Form
Patient Identification Form is created for this study by scanning the literature. In this form, there are 12 questions in total. The questions included the first letters of the name and surname for coding purposes. There are questions about the age, marital status, employment status, educational status, smoking, alcohol and snacking habits, regular insulin use, blood glucose measurement, physical activity, dietary compliance, and previous educations about diabetes.
Measured: a day before the education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start15 Dec 2019
- Primary completion15 May 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Dilek MUMCU, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266742
- Sponsor's protocol ID
- AnkaraYBU132435
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2022
- Last updated
- 4 Mar 2022
- 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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Web-based Education on Self-Care Management and Family Support in Women With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05266742
- Acronym / sponsor ID
- AnkaraYBU132435
- Conditions
- Diabetes Type 2
- Keywords
- Diabetes Mellitus, nurse, self care, web based education, family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 4 Mar 2022 (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 is a quasi-experimental study that was carried out to examine the effect of the web-based education given to female individuals using insulin with Type 2 diabetes on self-care management and family support.
Methods A randomized controlled trial using a sample (N=66) of women with type 2 diabetes who admitted to the hospital's outpatient clinic in 2020. The intervention group received web-based education for six months. Socio-demographic data, metabolic values, "Diabetes Self-Care Scale" and "Family Support and Conflict Scale in Type 2 Diabetes" were used.
Detailed description
Methods This quasi-experimental study was conducted in Ankara, Turkey, 2020. Sixty six patients were selected using convenient sampling and divided equally into two control and intervention groups based on random allocation. Web-based education was provided to the intervention group for six months. Data were collected before, at the third month of the intervention, and at the end of the intervention using "Patient Identification Form", "Metabolic Control Variables Form", "Diabetes Self-Care Scale" and "Family Support and Conflict Scale in Type 2 Diabetes" forms. All the patients were female individuals diagnosed with Type 2 diabetes at least a year ago, using insulin between the ages of 18 to 65 years old, who applied to the internal medicine and endocrine outpatient clinic of a training and research hospital in Ankara. Patients had no communication barriers, and they were able to use computers and smartphones and volunteer for this study. No consultancy training was given to the control group by the researcher. They only received routine education in the hospital.
Data Collection Tools Data is collected using "Patient Identification Form", "Metabolic Control Variables Form", "Diabetes Self-Care Scale" and "Family Support and Conflict Scale in Type 2 Diabetes" forms.
Patient Identification Form Patient Identification Form was created for this study by scanning the literature. In this form, there were 12 questions in total. The questions included the first letters of the name and surname for coding purposes. There were questions about the age, marital status, employment status, educational status, smoking, alcohol and snacking habits, regular insulin use, blood glucose measurement, physical activity, dietary compliance, and previous educations about diabetes.
Metabolic Control Variables Form Metabolic Control Variables Form was created for this study by scanning the literature. It had questions regarding the disease of the individuals. The questions were about fasting blood glucose, HbA1c, LDL, HDL, total cholesterol, triglycerides, weight, height, and body mass index.
Diabetes Self-Care Scale Diabetes Self-Care Scale is a survey. Diabetes Self-Care Scale was developed by Lee and Fisher in 2005. It aims to evaluate the self-care activities of patients with type 2 diabetes. This scale was adapted and translated to Turkish by Karakurt and Kaşıkçı in 2008. The options of the scale were changed to "Never (1)" "Sometimes (2)" "Frequently (3)" and "Always (4)". It has been stated that patients who score points more than 66% of the scale total points are assumed at a level to meet their self-care. Based on the 4-point Likert type, the maximum score of the scale was 140 points. As the score increases, the self-care activities of the patients increase positively. Diabetes Self-Care Scale contains 35 items. The scale does not have sub-dimensions and inverse expressions. These items aim to get information about eating on time, exercising, measuring and recording blood sugar, using oral antidiabetics and insulin as recommended, visiting a doctor for checking blood sugar, foot care, personal hygiene practices, diabetes, and its complications. While the Cronbach Alpha value of the scale developed by Lee and Fisher was determined to be 0.80, the total Cronbach Alpha coefficient of the scale in Karakurt's research was determined as 0.81.
Family Support and Conflict Scale in Type 2 Diabetes The Family Support and Conflict Scale in Type 2 Diabetes is a survey. The Family Support and Conflict Scale in Type 2 Diabetes was prepared by Charlotte Paddison in Japan in 2010 for individuals with type 2 diabetes. It consists of informative questions about the support status of the family and conflicts with the family. The scale was adapted to Turkish by Sofulu and Avdal in 2015 and the Cronbach Alpha coefficient of the scale is 0.740. DFSC has two sub-dimensions being 'Family Support' and 'Family Conflict'. The highest score obtained from the sub-dimensions was 50 and the lowest score was 10. As the subscale scores increase, the level of support increases. As the family conflict sub-dimension score decreases, the family conflict increase. The answers in the scale are 5-point Likert type and are classified as strongly agree, agree, undecided, disagree, strongly disagree. The scale contains 10 items in total. The items aim to get information to measure the family's attitude towards the diet, exercise, medications, and mental state of the diabetic.
Website An educative website was created for our study. The content of the website was accessible from "www.diyabet.mumcu.net" and the content of the website was brought together by scanning the literature. The content text was quoted from publicly available information and guides as ADA and IDF. The pictures on the website were obtained from license-free sources. The website also included a training video that was prepared by the researcher. The website was developed by using Microsoft Asp.NET MVC technology and it was designed responsively for ease of use. The website could be accessed from computers, tablets, and smartphones. Expert opinions were obtained using the DISCERN Measurement Tool to evaluate the reliability and quality of the training material. A username and a password were provided separately for each of the 33 individuals in the intervention group. In addition to the user content, the website had a separate management panel that was only used by the researcher. Using this admin panel, the researcher could see the pages that the participants in the intervention group accessed on the website, and the page visit times were available in logs. The content of the website is divided into training modules. These modules were published to the users sequentially during six months period by allowing access to a new module a month. A reminder message was sent twice a week to the user regarding the subject of the training module.
Application of Data Collection Tools Patient identification form, metabolic control variables form, Diabetes Self-Care Scale and Family Support and Conflict Scale in Type 2 Diabetes were administered face-to-face with interviews to the individuals included in the study when they came to their outpatient clinic appointments. In the third month of the study, the laboratory results of the hospital system were obtained and the form of metabolic control variables was recorded. It has been obtained from the routine laboratory results that were checked every three months upon the doctor's request. No blood was taken from individuals by the researcher. Web-based education was provided to the intervention group for six months. The metabolic control variables form, Diabetes Self-Care Scale and Family Support and Conflict Scale in Type 2 Diabetes were administered by the researcher using face-to-face interviews, e-mails, and mobile phone calls to the intervention and control groups based on their request at the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| END | Experimental | Other: web based educationUse of web based education |
| END free | No intervention | –patient witout of web based education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with Type 2 diabetes at least a year ago
- using insulin
- able to use computers and smartphones
Key exclusion criteria (1 listed)
- Not having been diagnosed with diabetes
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 |
|---|---|---|
| web based educationAn educative website was created for our study. The content of the website was accessible from "www.diyabet.mumcu.net" and the content of the website was brought together by scanning the literature. The content text was quoted from publicly available information and guides as ADA and IDF. | Other | END |
Primary outcome
Diabetes Self-Care Scale
Time frame: a day before the education
Diabetes Self-Care Scale Diabetes Self-Care Scale is a survey. It has been stated that patients who score points more than 66% of the scale total points are assumed at a level to meet their self-care. Based on the 4-point Likert type, the maximum score of the scale was 140 points. As the score increases, the self-care activities of the patients increase positively. It contains 35 items. These items aim to get information about eating on time, exercising, measuring and recording blood sugar, using oral antidiabetics and insulin as recommended, visiting a doctor for checking blood sugar, foot care, personal hygiene practices, diabetes, and its complications.
Family Support and Conflict Scale in Type 2 Diabetes
Time frame: a day before the education
The Family Support and Conflict Scale in Type 2 Diabetes is a survey. DFSC has two sub-dimensions being 'Family Support' and 'Family Conflict'. The highest score obtained from the sub-dimensions was 50 and the lowest score was 10. As the subscale scores increase, the level of support increases. As the family conflict sub-dimension score decreases, the family conflict increase. The answers in the scale are 5-point Likert type and are classified as strongly agree, agree, undecided, disagree, strongly disagree. The scale contains 10 items in total. The items aim to get information to measure the family's attitude towards the diet, exercise, medications, and mental state of the diabetic.
Metabolic Control Variables Form
Time frame: a day before the education
Metabolic Control Variables Form is created for this study by scanning the literature. It has questions regarding the disease of the individuals. The questions are about fasting blood glucose, HbA1c, LDL, HDL, total cholesterol, triglycerides, weight, height, and body mass index.
Patient Identification Form
Time frame: a day before the education
Patient Identification Form is created for this study by scanning the literature. In this form, there are 12 questions in total. The questions included the first letters of the name and surname for coding purposes. There are questions about the age, marital status, employment status, educational status, smoking, alcohol and snacking habits, regular insulin use, blood glucose measurement, physical activity, dietary compliance, and previous educations about diabetes.
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 4 Mar 2022.
- 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 web based education in people with Diabetes Type 2, run by Ankara Yildirim Beyazıt 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?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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 4 Mar 2022. 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?
Diabetes Self-Care Scale (time frame: a day before the education). The study lists 4 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 4 Mar 2022.