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临床试验/NCT06760715
NCT06760715尚未招募不适用

Constructing an Interactive Mobile Health Cloud Platform of Care Model on Self-management Among the Community-based Type 2 Diabetes Mellitus Patients with Sleep Obstructive Apnea: a Randomized Clinical Trial

Chang Gung University of Science and Technology1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2024年12月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
162
试验地点
1
主要终点
The primary outcome measure is the change in AHI (times/hour) detected by a home-use portable sleep monitor.

研究概览

简要总结

The aim of the second and third year is to construct the "Care model of improving for overweight or obese T2DM with OSA" based on the transtheoretical model, and to import an interactive m-health self-management (m-Health My OSA Coach; MOSAC)" cloud platform to examine the effectiveness of OSA in T2DM participants. A randomized controlled trial study design will be adopted. Eligible OSA participants who have been screened for OSA following the first stage will be invited to the second stage. The participants will be randomly divided into either experimental or control group with 1:1 ratio. The total duration of intervention program is 6 months. Only the experimental group receives the MOSAC intervention.

详细描述

Obstructive Sleep Apnea (OSA) is a common sleep disorder. It is estimated that nearly 1 billion adults are affected by OSA in worldwide. It is about 36-60% of Type 2 Diabetes Mellitus (T2DM) patients with OSA. Studies have shown that obesity is an independent risk factor for both OSA and T2DM, and the prevalence of obesity among adults in Taiwan has reached 45.4%. As a result, the incidence of T2DM has also increased annually and has become younger. For this reason, the OSA derived from it should not be underestimated. A three-year with longitudinal study will be conducted. In the first year, a cross-sectional study design is employed. Convenience sampling is used and 485 overweight community-based participants who will recruit from four diabetes co-care clinics in North and Central Taiwan. The Epworth Sleep Scale, Pittsburgh's Sleep Quality Index, Taiwanese depression Scale, Health Promotion Lifestyle Scale, and the home portable sleep monitor will be used for data collection. The aim of the second and third year is to construct the "Care model of improving for overweight or obese T2DM with OSA" based on the transtheoretical model, and to import an interactive m-health self-management (m-Health My OSA Coach; MOSAC)" cloud platform to examine the effectiveness of OSA in T2DM participants. A randomized controlled trial study design will be adopted. Eligible OSA participants who have been screened for OSA following the first stage will be invited to the second stage. The participants will be randomly divided into either experimental or control group with 1:1 ratio. The total duration of intervention program is 6 months. Only the experimental group receives the MOSAC intervention. All data will be collected at baseline, 3, and 6 months after intervention. Generalized estimating equation is employed to analyze the effectiveness of the intervention. Hopefully, the findings of this study will serve as a reference for the health care providers and will help construct a model of care for people with overweight and obese T2DM with OSA in the community.

研究设计

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

入排标准

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

入选标准

  • •Age over 20 years with a physician-confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM)
  • •BMI greater than 24 kg/m2, or waist circumference (WC) greater than 90cm for men or greater than 80 cm for women
  • •AHI as evaluated by a home portable sleep monitor at > 5 times/hour and diagnosed with sleep apnea by a specialist in sleep apnea
  • •agreeing to participate in this 6-month study .current digital technology product users.

排除标准

  • •presence of major diseases such as cancer , renal failure or severe depression
  • •presence of cardiopulmonary diseases not suitable for physical activities

研究组 & 干预措施

m-Health My OSA Coach

Experimental

干预措施: an interactive m-health self-management (Behavioral)

control group

Placebo Comparator

干预措施: In the control group (Behavioral)

结局指标

主要结局

The primary outcome measure is the change in AHI (times/hour) detected by a home-use portable sleep monitor.

时间窗: 24weeks

AHI is represented by the number of apnea and hypopnea events per hour of sleep. In this study, OSA was defined as the value of AHI greater than 5 events/ hr. In addition, participants were determined as having mild, moderate, and severe OSA if they had AHI 5-14 events /hr, 15-30 events /hr, and \> 30 events /hr, respectively (Jonas et al., 2017).

次要结局

  • The secondary outcome measures include changes in OSA-related factors such as HbA1c, BMI, sleep quality, daytime sleepiness, depression, and health-promoting lifestyle.(24weeks)

研究者

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

Hsu Hsiu-Chin

Associate professor

Chang Gung University of Science and Technology

研究点 (1)

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