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临床试验/NCT04092569
NCT04092569Unknown不适用

The Effectiveness of Pre-medical Consultation (PMC) Diabetes Self-care Education Programme on Glycemic Control in Adults With Type 2 Diabetes

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年9月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 9 months

研究概览

简要总结

This proposed project is a prospective randomized controlled trial to examine the clinical effects of pre-medical consultation structured diabetes self-care education program on intervention group (IG) versus control group (CG) for patients with type 2 diabetes in a specialist outpatient clinic of a regional hospital.

详细描述

Protocol Revised Date: 23 April 2019

Introduction Diabetes Mellitus (DM) is known as one of the major causes leading to cardiovascular diseases, stroke, diabetes kidney diseases, blindness or non-traumatic lower limb amputations. It is estimated that one in ten people to have diabetes and it has been projected that one in three adults will develop type 2 diabetes by 2050. Similarly, the prevalence of Type 2 Diabetes Mellitus (T2DM) in Hong Kong is estimated to be one in ten in adult population.

DM is a progressive metabolic disease and necessitates continuous medical care, diabetes self-management education and skills training to prevent or delay development of acute and chronic complications. Educating patients with diabetes in self blood glucose monitoring, healthy eating, regular physical activities, medication adherence, stress management and smoking cessation are important behavioral modifications required in diabetes self-care education. Besides providing education, diabetes nurses provide support and discuss with patients regarding their concerns and worries about diabetes and empower them to live their life positively with diabetes.

The Service Gap

Patients with diabetes with or without cardiovascular or renal comorbidities, are inevitably a burden to healthcare system. In Hong Kong and most other countries, if not all, patients are referred to specialist out-patient clinics (SOPC) for more advanced diabetes management from either general out-patient clinics (GOPC) or private practitioners (GP). Hence, these new case referrals from GOPC or GP are patients already have established DM on oral anti-diabetic drugs and/or insulin injections and with diabetes complications. Nevertheless, they have to wait for a long period of time, approximately one to two years before they could be seen at SOPC.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 Diabetes, age above 18 years old, who are 'newly referred' (established as well as newly diagnosed of DM) to specialist out-patient clinic at Alice Ho Miu Ling Nethersole Hospital
  • Suboptimal glycemic control of glycosylated haemoglobin, HbA1c >7%
  • Chinese and literate, able to answer questionnaires

排除标准

  • Inability to give informed consent.
  • Poor glycemic control with glycosylated haemoglobin, HbA1c >12% and/or related complications will receive early medical appointment or require hospital admission.
  • Having advanced diabetes related complications, e.g. diabetes kidney disease with glomerular filtration rate (eGFR) <30 mL/min/1.72m2
  • Life threatening condition with reduced life expectancy such as patients with cancer at terminal stage.
  • Those with active mental disorders and learning disability.

结局指标

主要结局

Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 9 months

时间窗: At baseline, week 36.

Blood HbA1c will be taken at baseline diabetes complication screening week 36 for both IG and CG.

Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 6 months

时间窗: At baseline, week 24.

Blood HbA1c will be taken at baseline diabetes complication screening, week 24 for both IG and CG.

次要结局

  • The Chinese version of the Diabetes Management Self-Efficacy Scale Questionnaire(At baseline, week 24 and week 36.)
  • The Chinese version of the Diabetes Empowerment Scale Questionnaire - Short Form(At baseline, week 24 and week 36.)

研究者

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

LAU Siu Wai Maggie

Principal Investigator

Chinese University of Hong Kong

研究点 (1)

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