Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05266742 |
| Other study ID # |
AnkaraYBU132435 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2019 |
| Est. completion date |
August 15, 2020 |
Study information
| Verified date |
February 2022 |
| Source |
Ankara Yildirim Beyazit University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
