JPRN-jRCT1030230650尚未招募Unknown
Research on self-management status for type 2 diabetes patients
Waki Kayo0 个研究点目标入组 70 人开始时间: 2024年2月22日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 76age old（—）
入选标准
- •(1) Diagnosed with type 2 diabetes and attending the hospital
- •(2) HbA1c is 7.5% or higher at the time of obtaining consent
- •(3) A short-sleeper - self-reports an average sleep duration in the prior month of 6 or fewer hours
- •(4) In the contemplation, preparation, or action stage of the transtheoretical model (TTM) for the action of sleeping 7 hours or
- •more per day
- •(5) Willing and able to wear a wristband-type measuring device on the non-dominant wrist during the research period
- •(6) Has and uses a mobile phone capable of sending and receiving SMS text messages
- •(7) Able to attend consultations at designated times during the research period
- •(8) 18 or older in age
- •(9) Fluent in spoken and written Japanese
- •(10) Does not have impaired cognitive function as determined by the investigator or sub investigator
- •(11) Can undergo sleep treatment, as determined by the investigator or sub investigator
- •(12) Fully informed about participation in this study, and has given free and voluntary written consent based on a thorough
- •understanding of the study
排除标准
- •(1) BMI is greater than 35.0 kg/m2
- •(2) Age is 76 years or older
- •(3) A shift worker, or someone who sometimes sleeps in a way other than with a single major sleep period at night
- •(4) A caregiver (of a child or adult) who needs to wake up during the night
- •(5) At high risk of obstructive sleep apnea syndrome (OSA)
- •(6) High possibility of insomnia
- •(7) Possibility of restless legs syndrome (RLS)
- •(8) High possibility of depression
- •(9) Taking medications that affect sleep
- •(10) Changed diabetes medication within the past 8 weeks
- •(11) Currently participating in another clinical research program
- •(12) A heavy user of alcohol
- •(13) Has severe chronic pain (due to cancer, etc.)
- •(14) Has a diagnosed clinical sleep disorder
- •(15) Has an uncontrolled psychiatric disorder
- •(16) Pregnant
- •(17) Any other reason why the patient is classified as unfit for participation by the investigator or sub investigator
研究者
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