The effect of telemedicine and cognitive behavioural therapy on sleep and health outcomes in type 2 diabetes patients: a randomized controlled trial

School of Medicine and Dentistry, Griffith University0 个研究点目标入组 326 人开始时间: 2023年5月12日最近更新: 2023年6月5日

适应症

试验速览

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•(1) Patients meet the diagnostic criteria for both type 2 diabetes and insomnia, and type 2 diabetes is the primary cause of insomnia
•(2) Patients aged over 18
•(3) Patients not currently participating in similar intervention programs
•(4) Patients fully understand the program contents, willing to participate and signed the informed consent form
•(5) Patients able to use smart phones or computers to receive and view intervention materials
•Diagnostic criteria for type 2 diabetes:
•(1) Fasting plasma glucose greater than or equal to 7.0 mmol/l (fasting time >8 hours)
•(2) Two-hour postprandial blood glucose greater than or equal to 11.1mmol/l
•(3) Random plasma glucose greater than or equal to 11.1 mmol/L in patients with classic symptoms of hyperglycemia or hyperglycemic crisis
•(4) Glycated Hemoglobin (HbA1c) greater than or equal to 6.5%
•Screening for insomnia: Insomnia Severity Index score greater than 10
•To determined if type 2 diabetes is the primary cause of insomnia:
•(1) Insomnia symptoms occurs or worsens after the diagnosis of type 2 diabetes.
•(2) Patients have worries about type 2 diabetes

•(1) Patients with severe primary diseases, including severe heart, liver or renal system diseases and cancer
•(2) Patients with severe psychiatric diseases that affect regular cognition and communication, including severe depression (HAMD score>18), anxiety (HAMA score>14) and schizophrenia
•(3) Patients diagnosed with sleep disorders other than insomnia, including obstructive sleep apnoea, restless leg syndrome, parasomnia and hypersomnia through self-report or PSG devices.
•(4) Patients who are pregnant
•(5) Patients who are illiterate and cannot understand the intervention contents.

发起方

School of Medicine and Dentistry, Griffith University