- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05228561
The Effect of Mobile Application Supported Diabetes Education On Type 2 Diabetes Self-Management And Blood Sugar Level
The Effect of Mobile Application Supported Diabetes Education On Type 2 Diabetes Self-Management And Blood Sugar In Newly Diagnosed Type 2 Diabetes Patients
Diabetes is one of the biggest public health problems of the 21st century. Type 2 diabetes mellitus accounts for more than 90% of all diabetes cases and is the most common type of diabetes. Type 2 diabetes, in which genetic and environmental factors play a role,It is a metabolic disorder in which insulin resistance, decrease in insulin secretion and incretin hormone deficiency are effective in its physiopathology, characterized by polydipsia, polyphagia and polyuria, where the organism cannot adequately benefit from carbohydrates, fats and proteins due to insulin deficiency or defects in the effect of insulin, which requires continuous medical care.
Diabetes is a major cause of blindness, end-stage renal disease, coronary artery disease, stroke and inferior extremity amputations. These complications due to diabetes impair the patient's quality of life and impose social, financial and emotional burdens on both the patient and their family.
Diabetes education should be provided by healthcare professionals in order to ensure that diabetes patients knowledge and skills to prevent complications and provide better self management and self-care.
However, The fact that individuals do not have time to spare for face-to-face health education, the possibility of accessing information in the web environment repeatedly and the lower cost of education in the web environment compared to classical education increases the importance of web-based health education. The widespread use of mobile technologies in recent years has led to the development of new mobile applications related to diabetes.
The disquisition proposal the investigators prepared was created to investigate the effect of mobile application supported diabetes and nutrition education on type 2 diabetes self-management and blood sugar in newly diagnosed type 2 diabetes patients.
In this context, with the development of a mobile application prepared in visual, text and video format to provide diabetes education, the monitoring of blood parameters before and after diabetes education, and the implementation of the Type 2 Diabetes Self-Management Scale, (which consists of 19 items developed in 2020), and type 2 diabetes self-management and the effect on blood sugar will be examined. This study will provide answers to questions about the effectiveness of diabetes education given to Type 2 Diabetes patients via mobile applications on diabetes self-management and blood parameters.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Newly diagnosed type 2 diabetes patients in the endocrinology and metabolism outpatient clinic of Ege University Medical Faculty Hospital.
- Patients with Type 2 DM, between the ages of 18-64, using smart phones and having regular internet will be included in the study.
Exclusion Criteria:
- Those who receive regular messages every day will be checked, and those who do not open/read more than 25% of the messages in total will be excluded.
- type 1 diabetes or gestational diabetes
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: Control Group
After the physician involved in the study asks the participants for their biochemical tests (FBC, HbA1C, LDL-C, HDL-C, Total K, Triglyceride), the outpatient dietitian will give routine nutrition education to the participants.
In addition, a data collection form including socio-demographic information, health history, nutrition history and height, weight, waist circumference measurements will be made and filled by the thesis student.
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Experimentální: Study Group
The software developed for this research will be downloaded to the phones of the participants in the intervention group.
With this software prepared, written and visual information (pictures, mini-videos) will be given to participants every day for 3 months on diabetes, self-management of diabetes and nutrition.
Whether the participants read the messages or not will also be monitored through this software.
At the end of 3 months, the participants in the intervention and control groups will be invited again, and their biochemical parameters and self-management status will be measured according to the diabetes self-management scale.
Data will be collected through face-to-face interviews in the outpatient clinic, and weight will be measured with the bioelectrical impedance analyzer in the outpatient clinic, height will be measured with a height meter fixed to the wall, and waist circumference will be measured with a non-stretchable measuring tape.
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With this intervention, the difference between the mobile application supported nutrition diabetes education created with written and visual (video) and face-to-face nutrition and diabetes education will be found.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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The effect of mobile application supported diabetes education on type 2 diabetes self-management.
Časové okno: 6 Month
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Type 2 diabetes self-management scores of the participants in the study group and control group will be compared. For this comparison, the "Type 2 Diabetes Self-Management Scale" consisting of 3 sub-titles (Healthy Lifestyle Behaviors, Blood Sugar Management, Health Services Use) and 19 items developed in 2020 will be applied. (Scoring: Always 5, Often 4, Sometimes 3, Rarely 2, Never 1 point). Those with higher scores will be considered to show better self-management. This scale will first be administered to the participants when they are diagnosed with type 2 diabetes in the hospital. Participants will be given diabetes and nutrition education for 3 months, and the Type 2 Diabetes Self-Management Scale will be repeated by inviting them to the hospital for control. Then, the participants will be taken into a 3-month follow-up process and at the end of the process, they will be invited to the hospital for control and the Type 2 Diabetes Self-Management Scale will be repeated. |
6 Month
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The effect of mobile application supported diabetes education on blood sugar
Časové okno: 6 Months
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The physician participating in the study will measure the Fasting Blood Sugar (mg/dl) values of the participants. When the participants are diagnosed with type 2 diabetes, their Fasting Blood Sugar (mg/dl) values will be measured and a 3-month diabetes education will be given. At the end of this diabetes training, the participants will be invited to the hospital for control and their Fasting Blood Sugar (mg/dl) values will be measured again. Then, the participants will be taken to the 3-month follow-up process and at the end of the process, the participants will be invited to the hospital for control and their Fasting Blood Sugar (mg/dl) values will be measured again. At the end of the research, the effects of mobile application supported diabetes education on fasting blood sugar (mg/dl) will be compared with the routine diabetes education given in the hospital. |
6 Months
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Satman I, Omer B, Tutuncu Y, Kalaca S, Gedik S, Dinccag N, Karsidag K, Genc S, Telci A, Canbaz B, Turker F, Yilmaz T, Cakir B, Tuomilehto J; TURDEP-II Study Group. Twelve-year trends in the prevalence and risk factors of diabetes and prediabetes in Turkish adults. Eur J Epidemiol. 2013 Feb;28(2):169-80. doi: 10.1007/s10654-013-9771-5. Epub 2013 Feb 14.
- American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available.
- Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002 Jul;25(7):1159-71. doi: 10.2337/diacare.25.7.1159.
- Chomutare T, Fernandez-Luque L, Arsand E, Hartvigsen G. Features of mobile diabetes applications: review of the literature and analysis of current applications compared against evidence-based guidelines. J Med Internet Res. 2011 Sep 22;13(3):e65. doi: 10.2196/jmir.1874.
- El-Gayar O, Timsina P, Nawar N, Eid W. Mobile applications for diabetes self-management: status and potential. J Diabetes Sci Technol. 2013 Jan 1;7(1):247-62. doi: 10.1177/193229681300700130.
- Zimmet P, Alberti KG, Magliano DJ, Bennett PH. Diabetes mellitus statistics on prevalence and mortality: facts and fallacies. Nat Rev Endocrinol. 2016 Oct;12(10):616-22. doi: 10.1038/nrendo.2016.105. Epub 2016 Jul 8.
- Satman I, Yilmaz T, Sengul A, Salman S, Salman F, Uygur S, Bastar I, Tutuncu Y, Sargin M, Dinccag N, Karsidag K, Kalaca S, Ozcan C, King H. Population-based study of diabetes and risk characteristics in Turkey: results of the turkish diabetes epidemiology study (TURDEP). Diabetes Care. 2002 Sep;25(9):1551-6. doi: 10.2337/diacare.25.9.1551.
- Sami W, Ansari T, Butt NS, Hamid MRA. Effect of diet on type 2 diabetes mellitus: A review. Int J Health Sci (Qassim). 2017 Apr-Jun;11(2):65-71.
- Millar A, Cauch-Dudek K, Shah BR. The impact of diabetes education on blood glucose self-monitoring among older adults. J Eval Clin Pract. 2010 Aug;16(4):790-3. doi: 10.1111/j.1365-2753.2009.01195.x. Epub 2010 Jun 14.
- Powers MA, Bardsley JK, Cypress M, Funnell MM, Harms D, Hess-Fischl A, Hooks B, Isaacs D, Mandel ED, Maryniuk MD, Norton A, Rinker J, Siminerio LM, Uelmen S. Diabetes Self-management Education and Support in Adults With Type 2 Diabetes: A Consensus Report of the American Diabetes Association, the Association of Diabetes Care & Education Specialists, the Academy of Nutrition and Dietetics, the American Academy of Family Physicians, the American Academy of PAs, the American Association of Nurse Practitioners, and the American Pharmacists Association. Diabetes Care. 2020 Jul;43(7):1636-1649. doi: 10.2337/dci20-0023. Epub 2020 Jun 8. No abstract available.
- Kelly L, Jenkinson C, Morley D. Experiences of Using Web-Based and Mobile Technologies to Support Self-Management of Type 2 Diabetes: Qualitative Study. JMIR Diabetes. 2018 May 11;3(2):e9. doi: 10.2196/diabetes.9743.
- Calderon JL, Shaheen M, Hays RD, Fleming ES, Norris KC, Baker RS. Improving Diabetes Health Literacy by Animation. Diabetes Educ. 2014 May;40(3):361-372. doi: 10.1177/0145721714527518. Epub 2014 Mar 27.
- Abrar EA, Yusuf S, Sjattar EL, Rachmawaty R. Development and evaluation educational videos of diabetic foot care in traditional languages to enhance knowledge of patients diagnosed with diabetes and risk for diabetic foot ulcers. Prim Care Diabetes. 2020 Apr;14(2):104-110. doi: 10.1016/j.pcd.2019.06.005. Epub 2019 Jul 13.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EgeUniversity-ETURHAN-001
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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