Effects of Multidisciplinary Intensive Targeted Care in Improving Diabetes Outcomes: a Randomized Controlled Pilot Study - the Integrated Diabetes Education, Awareness and Lifestyle Modification in Singapore (IDEALS) Program
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Composite primary endpoint
研究概览
简要总结
This study aims to investigate whether channeling purposefully structured resources to patients at high risk of developing diabetic complications to interdisciplinary team clinic consultations, interspersed with closer remote follow-up and aided by simple technology will be more effective than usual care in controlling diabetes mellitus, controlling multiple cardiovascular risk factors and reducing clinical event rates.
详细描述
The prevalence of diabetes in Singapore is estimated to grow from 400,000 to 670,000 by 2030 and an alarming one million by 2050 with the continuing rise in obesity prevalence. The current system currently has no formal stratification of patients for channelling of structured resources to patients that require more intensive treatment and follow-up (those at higher risk of progressing to having complications from diabetes due to poor glycemic control, or those who have signs of early complications).
We will therefore be researching effective health system delivery strategies to improve achievement of treatment targets (eg. HbA1c, blood pressure, LDL) and reduce vascular complications of diabetes mellitus (retinopathy, proteinuria, end stage renal disease, ischemic heart disease). These include:
- Stratification and channelling purposefully structured resources to patients with poorly controlled diabetes mellitus defined as having an HbA1c >9% on 2 or more occasions, and patients with diabetic complications (estimated glomerular filtration rate eGFR 30-60ml/min or proteinuria >0.5g/day or urine microalbumin:creatinine ratio >300mg/g)
- Training of all doctors/DNEs/dietitians involved in the counselling of patients in the field of motivational interviewing
- Providing easy accessibility to resources to allow patients to self-monitor their capillary blood glucose and blood pressure in between clinic visits - loaning of blood pressure units and glucometers for short (1-2 week) periods regularly
- Providing frequent telephone counselling by DNEs and Renal Pharmacists with regards to titration of medications, in particular ACE-inhibitors or angiotensin-receptor blockers to reach treatment targets
- Utilisation of social media and smart phone/tablet applications for relevant patients to improve and increase patient-healthcare professional interaction with regards to diabetes, provide daily bite-sized education via tablet/smart phone media/social media and improve compliance to exercise targets
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients aged 21-70 years
- •Poorly controlled diabetes with microalbuminuria as defined by the following HbA1C > 9.0% with eGFR30- 60 ml/min and/or proteinuria >0.5g/day and/or urine microalbumin:creatinine ratio >300 mg/g on 2 consecutive measurements 3 months apart
排除标准
- •Type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis.
- •Psychiatric conditions on medication
- •On weight loss medications or have had bariatric surgery
- •Life expectancy less than 12 months due to advanced cancers or other life-threatening conditions
研究组 & 干预措施
Standard Care
Patients randomized to the standard care group will receive usual care, which consists of clinic visits 4 monthly for review of BP, HbA1c and other investigations, and titration of medications;counseling with the diabetes nurse educator (DNE), and provision of educational materials on diabetes.
Intensive
Patient randomized to the intensive group will receive additional counselling and education by the DNE, medical social worker (MSW) on self-care and coping strategies for diabetes, and see the renal pharmacist for more intensive titration of antihypertensive medication between doctor visits. They will also be loaned blood pressure monitors and glucometers with test strips to perform self-monitoring at home in between outpatient visits. Smartphone and online technologies will be utilized to improve remote monitoring, education and self-care.
干预措施: Intensive (Behavioral)
结局指标
主要结局
Composite primary endpoint
时间窗: 3 years
Composite of Incidence of all diabetes-related endpoints including: 1. cardiovascular events (acute myocardial infarction, revascularisation procedures, heart failure, unstable angina, arrhythmia, stroke, transient ischemic attacks requiring hospital admissions) and related death 2. chronic kidney disease (eGFR\<60 ml/min/1.73m2) or end stage renal disease (dialysis and/or eGFR\<15 ml/min/1.73m2) and related death 3. visual impairment (corrected visual acuity of 20/200 or worse) or eye surgery (cataract removal, retinal surgery and vitrectomy) 4. lower extremity amputation or foot ulcers requiring hospitalizations 5. major infections - pulmonary and non-pulmonary requiring hospitalizations 6. all-site cancers 7. death
次要结局
- Composite secondary endpoint(3 years)