Self-care Behaviors of Type 2 Diabetes Mellitus Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Type 2 Diabetes. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Self-care Behaviours of Type 2 Diabetes Mellitus Patients: a Multicenter Prospective Observational Study With 2 Years Follow-up (SCUDOS)
Обзор
The goal of this observational study is to explore the experience of the chronic disease, with a particular focus on self-care, in adults with type 2 diabetes mellitus. The main questions it aims to answer are: * what is the association between self-care and glycated hemoglobin over time? * what are participants' clinical and sociodemographic characteristics influencing self-care behaviors? Participants' socio-demographic and clinical data will be collected by medical records and, at the beginning or at the end of the clinical standard outpatient visit, they will be asked to complete study questionnaires. The results of this study could be helpful in providing quality assistance, improving resource consumption, and reducing the onset of complications.
Первичные конечные точки
- Self-care in diabetes [1] [Срок оценки: The SCODI will be administered at the following time point: T0 - Baseline.]
- Self-care in diabetes [2] [Срок оценки: The SCODI will be administered by telephone at the following time point: T0.5 - Month 6 ± 28 days]
- Self-care in diabetes [3] [Срок оценки: The SCODI will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.]
- Self-care in diabetes [4] [Срок оценки: The SCODI will be administered by telephone at the following time point: T1.5 - Month 18 ± 28 days.]
- Self-care in diabetes [5] [Срок оценки: The SCODI will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.]
Вторичные конечные точки (3)
- Glycated Hemoglobin (HbA1c) [1] [Срок оценки: The HbA1c blood level will be collected from medical records at the following time point: T0 - Baseline.]
- Glycated Hemoglobin (HbA1c) [2] [Срок оценки: The HbA1c blood level will be collected from medical records at the following time point: T1 - Month 12± 28 days.]
- Glycated Hemoglobin (HbA1c) [3] [Срок оценки: The HbA1c blood level will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.]
Критерии участия
Критерии включения
- Diagnosis of type 2 diabetes;
- Age over 18 years old;
- Adequate comprehension of the Italian language;
- Signed and dated informed consent.
Критерии исключения
- Presence of documented psychiatric or neurodegenerative disease;
- Pregnancy;
- Any condition that, by the investigators' judgment, may limit adherence to study procedures
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 2 центра
- IRCCS Policlinico San Donato — San Donato Milanese
- Fondazione IRCCS San Gerardo dei Tintori — Monza
Публикации
- Riegel B, Dunbar SB, Fitzsimons D, Freedland KE, Lee CS, Middleton S, Stromberg A, Vellone E, Webber DE, Jaarsma T. Self-care research: Where are we now? Where are we going? Int J Nurs Stud. 2021 Apr;116:103402. doi: 10.1016/j.ijnurstu.2019.103402. Epub 2019 Aug 23. PMID 31630807
- Riegel B, Jaarsma T, Lee CS, Stromberg A. Integrating Symptoms Into the Middle-Range Theory of Self-Care of Chronic Illness. ANS Adv Nurs Sci. 2019 Jul/Sep;42(3):206-215. doi: 10.1097/ANS.0000000000000237. PMID 30475237
- Riegel B, Jaarsma T, Stromberg A. A middle-range theory of self-care of chronic illness. ANS Adv Nurs Sci. 2012 Jul-Sep;35(3):194-204. doi: 10.1097/ANS.0b013e318261b1ba. PMID 22739426
- Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, Maryniuk MD, Siminerio L, Vivian E. Diabetes Self-management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Clin Diabetes. 2016 Apr;34(2):70-80. doi: 10.2337/diaclin.34.2.70. No abst PMID 27092016
- Yuan C, Lai CW, Chan LW, Chow M, Law HK, Ying M. The effect of diabetes self-management education on body weight, glycemic control, and other metabolic markers in patients with type 2 diabetes mellitus. J Diabetes Res. 2014;2014:789761. doi: 10.1155/2014/789761. Epub 2014 Jul 17. PMID 25136645
- Walker RJ, Smalls BL, Hernandez-Tejada MA, Campbell JA, Egede LE. Effect of diabetes self-efficacy on glycemic control, medication adherence, self-care behaviors, and quality of life in a predominantly low-income, minority population. Ethn Dis. 2014 Summer;24(3):349-55. PMID 25065078
- Shrivastava SR, Shrivastava PS, Ramasamy J. Role of self-care in management of diabetes mellitus. J Diabetes Metab Disord. 2013 Mar 5;12(1):14. doi: 10.1186/2251-6581-12-14. PMID 23497559
- Ausili D, Barbaranelli C, Rossi E, Rebora P, Fabrizi D, Coghi C, Luciani M, Vellone E, Di Mauro S, Riegel B. Development and psychometric testing of a theory-based tool to measure self-care in diabetes patients: the Self-Care of Diabetes Inventory. BMC Endocr Disord. 2017 Oct 16;17(1):66. doi: 10.1186/s12902-017-0218-y. PMID 29037177
Идентификаторы
NCT: NCT07042399 · SCUDOS