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临床试验/NCT05183685
NCT05183685已完成不适用

Outcomes of a Risk Assessment and Management Program Using Telecare Consultation Among Patients With Diabetes Mellitus in General Out-patient Clinic: A Hybrid Effectiveness-implementation Study

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 780 人开始时间: 2022年12月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
780
试验地点
1
主要终点
HbA1c, defined as the amount of blood sugar attached to hemoglobin.

研究概览

简要总结

Telecare consultation, which is defined as a two-way synchronized visual (voice and image) communication between patients and healthcare professionals using telecommunication applications such as Zoom, has become a major trend in recent years. The current COVID-19 pandemic provides an impetus to drive change and increase the uptake of telecare consultation in healthcare. To the best of investigators' knowledge, there is no translational research available that simultaneously implements and evaluates the telecare model of care delivered in a primary care setting. The present study will be the first in Hong Kong to fill this service and knowledge gap in the care of DM patients.

研究设计

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

入排标准

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

入选标准

  • •aged 18 or above, having a confirmed diagnosis of diabetes, having regular follow-ups in the clinic

排除标准

  • •having dementia, having unaccompanied hearing or vision loss, not having an Internet connection at home

研究组 & 干预措施

Intervention group

Experimental

The participants will receive alternative telecare consultation and face to face consultation every 14 weeks.

干预措施: telecare consultation (Procedure)

Control group

Placebo Comparator

The participants will receive usual face to face consultation every 14 weeks.

干预措施: Usual face to face consultation (Procedure)

结局指标

主要结局

HbA1c, defined as the amount of blood sugar attached to hemoglobin.

时间窗: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)

An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months. It's a three-month average because that's typically how long a red blood cell lives. The blood glucose level will be measured at baseline pre-intervention, 42 weeks, and 84 weeks by a doctor.

次要结局

  • Fasting lipid profile that will be drawn by patient's blood. The profile includes high and low-density lipoprotein, cholesterol level, and triglyceride level(baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3))
  • body mass index, defined as the weight in kilograms divided by height in meters.(baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3))
  • Medication adherence(baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3))
  • Quality of life, defined by the standard of health, comfort, experienced by diabetic patients, which is measured by SF-12 questionnaire. SF-12 questionnaire can measure the physical and mental health components of quality of life among diabetic patients.(baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3))
  • Number of attendances at a general practitioners' office, emergency department, hospital, and general out-patient clinic(baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3))

研究者

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

Arkers, Wong

Assistant professor

The Hong Kong Polytechnic University

研究点 (1)

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