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临床试验/NCT03497390
NCT03497390已完成不适用

Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by an All-encompassing Program Led by a Diabetes Specialist Team (EMERALD)

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
207
试验地点
2
主要终点
Change in glycemic control

研究概览

简要总结

Obese type 2 diabetic patients are difficult to treat with many unmet needs requiring complex treatment regimens, intensive counselling and emotional support. Traditional anti-diabetic drugs, such as sulphonylureas and insulin, are known to have side-effects of weight gain and can offset the benefits of glycemic control and increase cardiovascular risks. Aside from these therapeutic challenges, psychological needs of these obese diabetic patients due to anxiety, stigmatization, stress, depression cannot be adequately addressed in a busy clinic setting. Here, the investigators propose to conduct this translational study aiming to compare the effects of a multi-component care program with personalized drug regimen augmented by behavioural therapy with psychological support and peer influence, led by a diabetes specialist team on metabolic control and psychobehavioural parameters in obese type 2 diabetic participants with poor glycemic control (glycated hemoglobin [HbA1c]>8%) versus usual care. The 1-year multi-component program will be followed by a 2-year observational period in the EMERALD group. Outcome measures will be assessed in all participants in the EMERALD and usual care group at 1-year and 3-year. The primary outcome was between-group differences in HbA1c from baseline to year 1 and year 3. The secondary outcomes were the proportion of patients who attained key performance indexes (KPIs; defined by reduction [Δ] in HbA1c≥0.5%, ΔSBP≥5 mmHg, ΔLDL-cholesterol≥0.5 mmol/L and Δbody weight≥3%) and BMI<25 kg/m2. systolic/diastolic BP, lipid levels (total cholesterol, LDL-cholesterol, triglyceride, high-density lipoprotein cholesterol [HDL-cholesterol]), obesity indices (body weight, BMI and waist circumference) and patient-reported outcomes. The latter included self-care and treatment adherence (assessed by 16-item Summary for Diabetes Self-Care Activities [SDSCA-16]), empowerment (assessed by Chinese Diabetes Empowerment Scale-10 [CDES-10]), quality of life (assessed by 5-item EuroQoL [EQ-5D]) and depression/anxiety (assessed by 9-item Patient Health Questionnaire [PHQ-9]) and 21-item Depression Anxiety Stress Scale [DASS-21]). A per-protocol analysis will be performed to assess the correlations between adherence to these activities and improvement in metabolic control.

详细描述

Aim: To examine the effects of 1-year team-based multi-component intervention care (MIC) program in obese T2D with poor glycemic control

Hypothesis: The change from a traditional clinic consultation to an individualized, multicomponent care program will improve cardiometabolic parameters in suboptimally treated obese type 2 diabetic participants.

Study design: This is a pilot translational study aiming to compare the effects of a multi-component care program with personalized drug regimen augmented by behavioural therapy with psychological support and peer influence, led by a diabetes specialist team on metabolic and psychobehavioural health in obese type 2 diabetic participants versus usual care (UC).

Settings: The participants would be identified from the Prince of Wales Hospital (PWH). The recruitment period would be 2 years. Since 1995, the PWH runs a comprehensive complication screening program in the ambulatory Diabetes Centre. On a weekly basis, 50-100 patients undergo assessments for risk factors and complications by nurses and healthcare assistants using standard protocols. On average, 8-12 patients attend each session. Since 2007, these data are entered into a web-based Joint Asia Diabetes Evaluation (JADE) Program which incorporates a validated risk engine to generate an integrated report with risk categories, care protocols, trends of risk factor control and decision support to empower both doctors and patients to make informed decisions. After the assessments, During the first two months of intervention, each group would have three 3.5-hour face-to-face workshops with the nurses (week 0, 4 and 8). This would be reduced to 2-hour per workshop 4-monthly thereafter in the following ten months (week 24, 40, 56) i.e. a total of six sessions per group in 1-year intervention. At each workshop, the nurses would use role plays, quizzes, reflective stories and on-site fitness classes to instill these key principles. Each workshop would use similar strategies including goal-setting, health behaviors tracking and peer sharing on personal progress. During this 1-year MIC program, 4 out of 6 workshops would be conducted when participants would be waiting to see endocrinologists (at week 24, 40 and 56). The consultations would be around 15-minute for each participant per visit. In the first two months of intervention, each MIC group also would receive three 20-minute telephone reminders from HCA at 4-weekly intervals (week 0, 4, 8). The call frequency would be reduced to 4-monthly intervals in the following ten months (week 24, 40, 56) i.e. a total of six calls per group. Group members would also be acted as peer supporters for one another in groups of 3 to 4 patients with at least one telephone reminder between workshops. The calls would be guided by structured log sheets focusing on adherence to lifestyle modification, medications and action plan, as well as to identify patients who would require ad-hoc support from the nurses.

The MIC group would return to UC after exit from the 1-year intervention. During the ensuing two years, the MIC group would receive mailing of three simplified JADE follow-up reports at month 18, month 24 and month 30 where the HCA entered BP, HbA1c, body weight and LDL-cholesterol retrieved from the clinic notes or laboratory measurements to provide feedback to the patients. They would be invited to an annual 4-hour group gathering where doctors and nurses would invite patients who achieve and/or maintain risk factor control to share their success stories and provide motivational support to the group.

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

盲法说明

Open label

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetic patients
  • Obesity as defined as body mass index (BMI) ³27 kg/m2 and/or waist circumference (WC) ³80cm in women and ³90cm in men
  • Poor glycemic control as defined as HbA1c³8%
  • Age between 18-70 years

排除标准

  • Type 1 diabetes
  • Active malignant disease (Patients with malignant disease who have been disease-free for at least 5 years are eligible)
  • Life expectancy less than 12 months
  • Any medical illness or condition as judged by the investigators as ineligible to participate the study

结局指标

主要结局

Change in glycemic control

时间窗: From baseline to 1-year and 3-year

Primary outcome measures will be a change from baseline HbA1c at 1-year and 3-year between the two groups.

次要结局

  • Change in blood pressure (BP)(From baseline to 1-year and 3-year)
  • Change in body mass index [BMI](From baseline to 1-year and 3-year)
  • Change in waist-hip ratio [WHR](From baseline to 1-year and 3-year)
  • Change in low-density lipoprotein (LDL) cholesterol(From baseline to 1-year and 3-year)
  • Change in waist circumference [WC](From baseline to 1-year and 3-year)

研究者

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

Alice Pik Shan KONG

Professor

Chinese University of Hong Kong

研究点 (2)

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