- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04626531
The Effect of Web-Based Education in Patients With Type 2 Diabetes
11. november 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
89
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Kontrolgruppe
Kontrolgruppen påførte ingen interferens under undersøgelsen.
Deltagerne i kontrolgruppen fortsatte deres rutinemæssige opfølgning.
|
Kontrolgruppen påførte ingen interferens under undersøgelsen.
Deltagerne i kontrolgruppen fortsatte deres rutinemæssige opfølgning.
|
|
Eksperimentel: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Spørgeskemaet Diabetes Self-Care Activities
Tidsramme: 5 minutter
|
Diabetes Self-Care Activities Questionnaire blev udviklet af Toobert og Glasgow for at bestemme egenomsorgsaktiviteterne for personer med diabetes.
Den tyrkiske validitet og pålidelighed af spørgeskemaet blev udført af Kav et al. (2010) og den samlede Cronbach alfa-værdi blev fundet 0,72.
Værktøjet indeholder 11 elementer, som måler hyppigheden af at udføre diabetes-selvplejeaktiviteter i løbet af de sidste syv dage, herunder kost, motion, blodsukkermåling, fodpleje og tobaksbrug.
Skalaens samlede score spænder mellem 0-7.
Højere score indikerer flere egenomsorgsaktiviteter.
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5 minutter
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Metabolic Control Variable Form
Tidsramme: 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.
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5 minute
|
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The Self-Efficacy Scale for Patients with Type 2 Diabetes Mellitus
Tidsramme: 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.
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5 minute
|
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The Diabetes Quality of Life Scale
Tidsramme: 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.
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5 minute
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Website Analysis and Measurement Inventory
Tidsramme: 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.
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5 minute
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Mustafa Kemal Balci, Proof, Akdeniz University Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. januar 2016
Primær færdiggørelse (Faktiske)
15. februar 2017
Studieafslutning (Faktiske)
15. april 2018
Datoer for studieregistrering
Først indsendt
6. november 2020
Først indsendt, der opfyldte QC-kriterier
6. november 2020
Først opslået (Faktiske)
12. november 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MAKU
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
All authors contributed to the interpretation, writing, and approval of the final manuscript.
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