The Effect of Web-Based Education in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Educational Problems
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-Based Education
Control Group
Sponsored by

About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Nursing, Type 2 diabetes, Web based education program, Self efficacy, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 18-65
- Diagnosed with type 2 diabetes at least six months ago
- Not have communication disabilities
- Used insulin
- Phone and internet connection
Exclusion Criteria:
- Have a physical, cognitive or mental disability to answer questions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention Group
Control Group
Arm Description
After the pre-tests (Self-Care Activities, Self-Efficacy, Quality of Life) , the patients were given web based education and containing information and recommendations on self-management strategies for three months.
The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.
Outcomes
Primary Outcome Measures
Metabolic Control Variable Form
It is a 9-item information form that questions the participants' clinical measurements including height, weight, body mass index, blood pressure, and laboratory results including blood glucose, HbA1c, cholesterol, triglyceride, and microalbuminuria level.
The Diabetes Self-Care Activities Questionnaire
The Diabetes Self-Care Activities Questionnaire was developed by Toobert and Glasgow to determine the self-care activities of individuals with diabetes. The Turkish validity and reliability of the questionnaire were conducted by Kav et al. (2010) and the total Cronbach alpha value was found 0.72. The tool contains 11 items, which measure the frequency of performing dia- betes self-care activities over the last seven days including diet, exercise, blood glucose testing, foot care and tobacco use. The scale total score ranges between 0-7. Higher scores indicate more self-care activities.
The Self-Efficacy Scale for Patients with Type 2 Diabetes Mellitus
The Self-Efficacy Scale for Patients with Type 2 Diabetes Mellitus was developed in 1999 by Van der Bijl et al. The Turkish validity and reliability of the scale were performed by Kara et al. (2006). The total Cronbach alpha value was found to be 0.88. The scale consists of 20 items in 5-point Likert type. Responses to the scale; "Yes, I'm sure" 5 points "No, I'm not sure" are evaluated as 1 point. The scale total score ranges between 20-100. High scores according to scale total scores indicate good self-efficacy.
The Diabetes Quality of Life Scale
The Diabetes Quality of Life Scale was developed by Jacobson et al to evaluate the quality of life of individuals with diabetes (Jacobson, Groot, & Samson, 1994). The Turkish validity and reliability study of the scale was conducted by Yıldırım et al (2007). The total Cronbach alpha value of the scale was found to be 0.89. The scale total score ranges between 46-230. High scores according to scale total scores indicate good quality of life.
Secondary Outcome Measures
Website Analysis and Measurement Inventory
The Website Analysis and Measurement Inventory is a scale based on software evaluation for usability and international software standards. WAMMI is used for the evaluation of websites in many areas. The inventory includes the sub-dimensions of attractiveness, controllability, efficiency, helpfulness, learnability, global usability. The scale total score ranges between 0-100. The scores on the WAMMI are given as percentages, higher percentages indicate higher usability.
Full Information
NCT ID
NCT04626531
First Posted
November 6, 2020
Last Updated
November 11, 2020
Sponsor
Mehmet Akif Ersoy University
Collaborators
Akdeniz University
1. Study Identification
Unique Protocol Identification Number
NCT04626531
Brief Title
The Effect of Web-Based Education in Patients With Type 2 Diabetes
Official Title
The Effect of Web-Based Education Program on Metabolic Control, Self-Care Activities, Self-Efficacy and Quality of Life in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2016 (Actual)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
April 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mehmet Akif Ersoy University
Collaborators
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research was designed as a randomized controlled study to develop a web-based training program and evaluate the program's impact on diabetes management. This research was carried out on 89 patients diagnosed with type 2 diabetes in the Department of Endocrinology and Metabolic Diseases of Akdeniz University. The preparation of the web page and its content has benefited from the latest literature, national and international websites, and expert opinions. Individuals in the survey scope have been stratified random method with as intervention group (n=44) and control group (n=45). Individuals who were taken in the initiative group were informed by web page, SMS, e-mail prepared for a period of three months. Personal information forms Metabolic Control Variable Form, Diabetes Self-Care Activities Questionnaire, Self-Efficacy Scale for Type 2 Diabetic Individuals, Diabetes-Specific Quality of Life Scale and Web Site Analysis and Measurement Inventory were used as the data tools. The informed consent was obtained from the patients and all data were collected by author during face-to-face interviews.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Educational Problems
Keywords
Nursing, Type 2 diabetes, Web based education program, Self efficacy, Quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
They did not know if they were in the control and intervention group at the time of randomization.
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
After the pre-tests (Self-Care Activities, Self-Efficacy, Quality of Life) , the patients were given web based education and containing information and recommendations on self-management strategies for three months.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.
Intervention Type
Other
Intervention Name(s)
Web-Based Education
Intervention Description
Participants in the intervention group had unlimited access to the Web site, free of charge. The Web site was designed to run on personal computers and smartphones.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.
Primary Outcome Measure Information:
Title
Metabolic Control Variable Form
Description
It is a 9-item information form that questions the participants' clinical measurements including height, weight, body mass index, blood pressure, and laboratory results including blood glucose, HbA1c, cholesterol, triglyceride, and microalbuminuria level.
Time Frame
5 minute
Title
The Diabetes Self-Care Activities Questionnaire
Description
The Diabetes Self-Care Activities Questionnaire was developed by Toobert and Glasgow to determine the self-care activities of individuals with diabetes. The Turkish validity and reliability of the questionnaire were conducted by Kav et al. (2010) and the total Cronbach alpha value was found 0.72. The tool contains 11 items, which measure the frequency of performing dia- betes self-care activities over the last seven days including diet, exercise, blood glucose testing, foot care and tobacco use. The scale total score ranges between 0-7. Higher scores indicate more self-care activities.
Time Frame
5 minute
Title
The Self-Efficacy Scale for Patients with Type 2 Diabetes Mellitus
Description
The Self-Efficacy Scale for Patients with Type 2 Diabetes Mellitus was developed in 1999 by Van der Bijl et al. The Turkish validity and reliability of the scale were performed by Kara et al. (2006). The total Cronbach alpha value was found to be 0.88. The scale consists of 20 items in 5-point Likert type. Responses to the scale; "Yes, I'm sure" 5 points "No, I'm not sure" are evaluated as 1 point. The scale total score ranges between 20-100. High scores according to scale total scores indicate good self-efficacy.
Time Frame
5 minute
Title
The Diabetes Quality of Life Scale
Description
The Diabetes Quality of Life Scale was developed by Jacobson et al to evaluate the quality of life of individuals with diabetes (Jacobson, Groot, & Samson, 1994). The Turkish validity and reliability study of the scale was conducted by Yıldırım et al (2007). The total Cronbach alpha value of the scale was found to be 0.89. The scale total score ranges between 46-230. High scores according to scale total scores indicate good quality of life.
Time Frame
5 minute
Secondary Outcome Measure Information:
Title
Website Analysis and Measurement Inventory
Description
The Website Analysis and Measurement Inventory is a scale based on software evaluation for usability and international software standards. WAMMI is used for the evaluation of websites in many areas. The inventory includes the sub-dimensions of attractiveness, controllability, efficiency, helpfulness, learnability, global usability. The scale total score ranges between 0-100. The scores on the WAMMI are given as percentages, higher percentages indicate higher usability.
Time Frame
5 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18-65
Diagnosed with type 2 diabetes at least six months ago
Not have communication disabilities
Used insulin
Phone and internet connection
Exclusion Criteria:
Have a physical, cognitive or mental disability to answer questions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Kemal Balci, Proof
Organizational Affiliation
Akdeniz University Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All authors contributed to the interpretation, writing, and approval of the final manuscript.
Citations:
PubMed Identifier
21099675
Citation
Avdal EU, Kizilci S, Demirel N. The effects of web-based diabetes education on diabetes care results: a randomized control study. Comput Inform Nurs. 2011 Feb;29(2):101-6. doi: 10.1097/NCN.0b013e3181fcbdc6.
Results Reference
background
PubMed Identifier
28954789
Citation
Murray E, Sweeting M, Dack C, Pal K, Modrow K, Hudda M, Li J, Ross J, Alkhaldi G, Barnard M, Farmer A, Michie S, Yardley L, May C, Parrott S, Stevenson F, Knox M, Patterson D. Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care. BMJ Open. 2017 Sep 27;7(9):e016009. doi: 10.1136/bmjopen-2017-016009.
Results Reference
result
PubMed Identifier
25495847
Citation
Yu CH, Parsons JA, Mamdani M, Lebovic G, Hall S, Newton D, Shah BR, Bhattacharyya O, Laupacis A, Straus SE. A web-based intervention to support self-management of patients with type 2 diabetes mellitus: effect on self-efficacy, self-care and diabetes distress. BMC Med Inform Decis Mak. 2014 Dec 14;14:117. doi: 10.1186/s12911-014-0117-3.
Results Reference
result
Learn more about this trial
The Effect of Web-Based Education in Patients With Type 2 Diabetes
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