Effects of Using Decision Cycle for Person-Centered Glycemic Management in Type 2 Diabetes

Официальное название

Research on the Effectiveness of Using Decision Cycle for Person-Centered Glycemic Management on Self-Care Behaviors in Outpatients With Type 2 Diabetes

Обзор

Decision cycle for person-centered glycemic management is a new diabetes decision making .It is defined as a purposefully designed holistic care intervention .The goal is to improve the self-care behavior of patients with type 2 diabetes, thereby improving glycated hemoglobin levels and delaying the occurrence of complications.

Подробное описание

The "Decision Cycle for Person-Centered Glycemic management" jointly proposed by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) in 2018 , which develops treatment goals and plans based on the patient's personal preferences, values, and goals.

Participants will be divided into two groups(treatment group 、control group).Treatment group will accept the "Decision Cycle for Person-Centered Glycemic Management " .It is a person-centered diabetes decision making. Control group will accept the traditional diabetes self-management education. It content focuses more on teaching relevant knowledge and some skills.It is a educator-centered approach.

Baseline / pre-intervention test (after signing informed consent form) post-intervention test (after finishing intervention) Researchers will compare treatment group and control group to see if treatment group has better performance on self-care Behaviors and glycated hemoglobin levels .

Вмешательства

• Поведенческое Decision Cycle for Person-Centered Glycemic Management
  It is defined as a purposefully designed holistic care intervention that improve self-management .
• Другое Traditional diabetes self-management education
  Traditional diabetes self-management education content focuses more on teaching relevant knowledge and some skills.

Первичные конечные точки

• glycemic control (HbA1c) [Срок оценки: Before the task and 3 months post intervention]

Вторичные конечные точки (1)

• Diabetes Self-Care Behavior Scale [Срок оценки: Before the task and 3 months post intervention]

Критерии участия

Критерии включения

• Patients diagnosed with type 2 diabetes by a physician.
• Age: 18 years or above.
• Glycated hemoglobin (HbA1c ) test value: 7.5-9.0 %
• No diabetic oral medications, insulin and glucagon-like peptide-1 were replaced in the outpatient when the case was admitted.
• No pregnancy during the study period.
• After the researcher explains the purpose of the research, the research subjects agree to join this researcher.
• Those who are conscious and able to take care of themselves.
• There is no diagnostic certificate from the American Psychiatric Association's Diagnostic Manual of Mental Disorders, Fourth Edition (DSM-IV)of all mental illnesses.
• Those who can communicate in Mandarin and Taiwanese.

Критерии исключения

• Patients diagnosed with type 1 diabetes by a physician.
• Age: Under 18 years old.
• Glycated hemoglobin test value: less than 7.5 % and greater than 9.0 %
• Those who replaced oral diabetes medications, insulin and glucagon-like peptide- 1 at the outpatient at the time of admission.
• Pregnancy during the study period.
• Those who are unable to take care of themselves and express themselves.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Hsinchu

Идентификаторы

NCT: NCT06331338 · 202310085RIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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