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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04626531
Other study ID # MAKU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2016
Est. completion date April 15, 2018

Study information

Verified date November 2020
Source Mehmet Akif Ersoy University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date April 15, 2018
Est. primary completion date February 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Web-Based Education
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.
Control Group
The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Mehmet Akif Ersoy University Akdeniz University

References & Publications (3)

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. — View 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-Diabete — View 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 dist — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 minute
Primary 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. 5 minute
Primary 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. 5 minute
Primary 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 Yildirim 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 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. 5 minute
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