- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04626531
The Effect of Web-Based Education in Patients With Type 2 Diabetes
November 11, 2020 updated by: Nurten Terkes, Mehmet Akif Ersoy University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control Group
The control group didn't apply any interference during the study.
Participants in the control group continued their routine follow-up.
|
The control group didn't apply any interference during the study.
Participants in the control group continued their routine follow-up.
|
Experimental: Intervention Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Diabetes Self-Care Activities Questionnaire
Time Frame: 5 minute
|
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.
|
5 minute
|
Metabolic Control Variable Form
Time Frame: 5 minute
|
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.
|
5 minute
|
The Self-Efficacy Scale for Patients with Type 2 Diabetes Mellitus
Time Frame: 5 minute
|
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.
|
5 minute
|
The Diabetes Quality of Life Scale
Time Frame: 5 minute
|
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.
|
5 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Website Analysis and Measurement Inventory
Time Frame: 5 minute
|
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.
|
5 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Mustafa Kemal Balci, Proof, Akdeniz University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2016
Primary Completion (Actual)
February 15, 2017
Study Completion (Actual)
April 15, 2018
Study Registration Dates
First Submitted
November 6, 2020
First Submitted That Met QC Criteria
November 6, 2020
First Posted (Actual)
November 12, 2020
Study Record Updates
Last Update Posted (Actual)
November 13, 2020
Last Update Submitted That Met QC Criteria
November 11, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAKU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All authors contributed to the interpretation, writing, and approval of the final manuscript.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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