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临床试验/NCT05629117
NCT05629117已完成不适用

The Effects of Personalized Diabetes Text Messaging (DB-TEXT) Combined With Peer Support Education in Patients With Type 2 Diabetes: A Randomized Controlled Trial

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2022年12月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
2
主要终点
Changes in fasting blood glucose level

研究概览

简要总结

The purpose of this study to investigate the effects of personalized diabetes text messaging (DB-TEXT) combined with PSE in patients with type 2 diabetes. This study is an assessor-blinded, three-arm, parallel randomized controlled trial. Additionally, the investigators will use the CONSORT guidelines to report of trial finding. A diabetes management centers in East Java Province will be recruited for the participants from December 2022 to March 2023. The investigators will include participants who had been diagnosed with poorly controlled type 2 diabetes (having HbA1C level of > 7% in the past three months), and who were 17 years or older (the legal age to provide informed consent in Indonesia) and having their own mobile phone. People who could not read or write Indonesian; had medical diagnostic with cognitive impairments, psychiatric disorders, or were diagnosed with cancer before the study will be excluded from the study. The outcomes of the study including demographic and disease characteristic, clinical outcomes, fatigue, sleep quality, depression, and quality of life. For the clinical outcomes, will be measured in laboratory test in diabetes management centers. Fatigue level will be measured using the Multidimensional Fatigue Inventory-20 (MFI-20), sleep quality will be measured using a Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory-Second Edition (BDI-II) will be used to measure the depression level, and the Diabetes Quality of Life-Brief Clinical Inventory (The DQoL-BCI) will be used to assess the quality of life.

详细描述

Background :

Our early component network meta-analysis (CNMA) study showed that short message service (SMS) and peer support education (PSE) are the most effective component of digitally assisted intervention in improving HbA1C level in type 2 diabetes.

Purposes:

The purpose of this study to investigate the effects of personalized diabetes text messaging (DB-TEXT) combined with PSE in patients with type 2 diabetes.

Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who had been diagnosed with poorly controlled type 2 diabetes (having HbA1C level of > 7% in the past three months)
  • Participants ho were 17 years or older (the legal age to provide informed consent in Indonesia)
  • having their own mobile phone

排除标准

  • People who could not read or write Indonesian
  • Had medical diagnostic with cognitive impairments
  • Psychiatric disorders, or were diagnosed with cancer

结局指标

主要结局

Changes in fasting blood glucose level

时间窗: at baseline, 3 months, 6 months

Fasting blood glucose level of participants will be assessed using glucometer

Changes in Lipids level including total cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) , and triglycerides

时间窗: at baseline, 3 months, 6 months

The total cholesterol, LDL, HDL, and triglycerides of the participants will assessed in the laboratory test in hospital

Changes in Blood Pressure Level including Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)

时间窗: at baseline, 3 months, 6 months

Blood pressure of participants will be measured using sphygmomanometer

Changes in HbA1C level

时间窗: at baseline, 3 months, 6 months

HbA1C level of participants will be assessed in the laboratory test in hospital

次要结局

  • Changes in Quality of Life(At baseline, 3 months, 6 months)
  • Changes in Fatigue(At baseline, 3 months, 6 months)
  • Changes in Depression(At baseline, 3 months, 6 months)
  • Changes in Sleep Quality(At baseline, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsiao-Yean Chiu

Principal Investigator

Taipei Medical University

研究点 (2)

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