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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
Mehmet Akif Ersoy University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 6, 2020
    Last Updated
    November 11, 2020
    Sponsor
    Mehmet Akif Ersoy University
    Collaborators
    Akdeniz University
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    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

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    The Effect of Web-Based Education in Patients With Type 2 Diabetes

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