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Diabetes Mellitus, Type 2NCT04626531

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

A study testing Web-Based Education in people with Diabetes Mellitus, Type 2 and Educational Problems, run by Mehmet Akif Ersoy University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Web-Based Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
No sites listed yet
Study dates
10 Jan 2016to 15 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Have a physical, cognitive or mental disability to answer questions

About this study

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

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.

Being tested
Web-Based Education, Control Group
Keywords
Nursing, Type 2 diabetes, Web based education program, Self efficacy, Quality of life
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-Based EducationOther

    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 GroupOther

    The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.

Study groups in NCT04626531
Study groupRoleWhat they receive
Intervention GroupExperimentalAfter 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.
Receives: Other: Web-Based Education
Control GroupExperimentalThe control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 minute

  2. 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.

    Measured: 5 minute

  3. 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.

    Measured: 5 minute

  4. 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.

    Measured: 5 minute

Secondary outcomes (1)

  1. 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.

    Measured: 5 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start10 Jan 2016
  3. Primary completion15 Feb 2017
  4. Study completion15 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04626531
Sponsor's protocol ID
MAKU
Status last verified
Nov 2020
First submitted
6 Nov 2020
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All authors contributed to the interpretation, writing, and approval of the final manuscript.

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.

    PubMed 21099675

  • 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.

    PubMed 28954789

  • 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.

    PubMed 25495847

  • Terkes N, Bektas H, Balci MK. Effect of web-based education intervention on blood glucose control, self-care and quality of life in patients with type 2 diabetes: A single-blinded randomized controlled trial. Int J Nurs Pract. 2024 Dec;30(6):e13298. doi: 10.1111/ijn.13298. Epub 2024 Aug 18.

    PubMed 39155430

Questions about this trial

What is this clinical trial studying?

A study testing Web-Based Education in people with Diabetes Mellitus, Type 2 and Educational Problems, run by Mehmet Akif Ersoy University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic Control Variable Form (time frame: 5 minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04626531, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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