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临床试验/NCT02199834
NCT02199834已完成不适用

A Quality Improvement Project Evaluating the Effect of Regular Personalized Feedback Report and Peer Support for Patients With Diabetes in Hong Kong

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 1,488 人开始时间: 2013年2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
1,488
试验地点
2
主要终点
Hospitalization

研究概览

简要总结

In this project, the investigators hypothesize that in an integrated, multifaceted, team-based program incorporating comprehensive assessment with risk stratification, diabetic patients with high risk of negative emotions and hospitalization will benefit from additional peer support which will improve their psychological health, cardio-metabolic control, self-management, quality of life and reduce hospitalization. The investigators further hypothesize that peer support will interact with regular personalized feedback reporting to improve clinical outcomes.

详细描述

Diabetes self-management is often emotionally and physically taxing, demanding lifelong commitment to medication adherence and lifestyle modification. People with diabetes have to be well-educated and supported to make clinical decisions in their daily living. However, most diabetes self-management education (DSME) interventions are short-term and have little external support. In order to empower patients to self-manage over a lifetime after the initial DSME, ongoing multidisciplinary programs which coordinates individual components of care into a structured system and further supported by reinforcement through multiple contacts are necessary to provide practical tips as well as social and psychological support to diabetic patients, so as to sustain behavioral changes and improve metabolic control.

Based on these principles, the Joint Asia Diabetes Evaluation (JADE) Program was developed in 2007 as a quality improvement initiative to deliver technologically integrated and multidisciplinary team-based care. It is enabled by a web-based portal containing templates which guide care providers in providing standardized comprehensive assessments, the results of which are then used for personalized risk stratification and feedback reports. The personalized feedback report contains the patient's risk category according to the JADE definition, with visual displays of important trends including those of glycated haemoglobin (HbA1c), blood pressure (BP), low-density-lipoprotein-cholesterol (LDL-C), and body mass index (BMI), and practical suggestions to help the individual to reach multiple treatment targets based on the latest values.

On the other hand, according to a recent WHO consultation report, peer support intervention is considered to have enormous potential to improve self-management in patients with chronic disease. Programs using peer supporters to teach and support their peers with diabetes have shown significant reductions in HbA1c, enhanced self-efficacy, improved health status and better self-management behaviors. In our previous study, we found that a combined program which integrates structured care, peer support and clinical decision support by regular follow up report significantly improved psychological health and medication adherence of diabetic patients, and reduced hospitalization of patients with negative emotions like depression, distress, and anxiety, who were most likely to suffer from chronic kidney disease or poor glycemic control. In this program, we hypothesize that using a multifaceted program which incorporates structured care, personalized feedback reporting, and peer support to influence and motivate diabetic patients with high risk of hospitalization and negative emotions on diabetes self-management, will further improve their self-management, psychological health and metabolic control, and reduce hospitalization. We further hypothesize that receiving personalized feedback report with decision support will improve glycemic control and reduce hospitalization in patients with diabetes.

Around 286 patients with high risk of negative emotion and hospitalization will be invited to join the peer support program. We anticipate that half of the patients will agree (n=143) and be assigned 24 peer supporters on a 5~6:1 ratio. Peer supporters are patients who have good glycemic control and self-care and trained to provide both informational and emotional support to the peer group. For patients who decline to participate, they will be identified as refused peer group and their reasons for declining will be documented. Half of the patients in each group will be randomized to receive 2 personalized feedback reports through the mail.

1200 adult patients consecutively enrolled in JADE program will be recruited and half of them (n=600) will be randomized to receive a personalized feedback report twice a year. All patients will be followed up at their usual clinics and will be observed for at least 1 year when we shall evaluate the effects of providing regular personalized report on clinical outcomes including metabolic control and hospitalization.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • For peer supporters:
  • Patients with type 2 diabetes.
  • Aged between 18 and 75 years (inclusive).
  • Chinese ethnicity.
  • Stable glycemic control (HbA1c<7.5%) and self-rated health status≥80 as assessed by EQ5D visual scale.
  • Enthusiastic and willing to become peer supporters.
  • Patients with diabetes.
  • Aged between 18 and 75 years (inclusive).
  • Chinese ethnicity.
  • At least 1 of the following risk factors: HbA1c≧8%/ BMI≧27.5 kg/m2/ Waist circumstance≧80cm in women or ≧90cm in men/ Chronic kidney disease (CKD) defined as estimated glomerular filtration rate less than 60 ml/min /1.73m
  • Agree to receive peer support
  • For report group and usual care group:
  • All Chinese diabetes patients between 18-75 years of age who undergo comprehensive assessment and join the JADE program.

排除标准

  • For peer supporters:
  • HbA1c≧7.5% in last 6 months.
  • Terminal malignancy or other life-threatening diseases.
  • Unstable mental diseases.
  • Unable to communicate in Chinese.
  • Terminal malignancy or other life-threatening diseases.
  • Unstable mental illness.
  • Unable to communicate in Chinese.

结局指标

主要结局

Hospitalization

时间窗: 12 months

The number of, and the corresponding reasons for hospital admissions, using the International Classification of Diseases-9th version in the discharge summary, retrieved from the Hong Kong Hospital Authority Central Computer System.

Change of HbA1c

时间窗: 12 months

次要结局

  • Changes in self-efficacy(12 months)
  • Change in quality of life(12 months)
  • Change in health-related quality of life(12 months)
  • Change in cardio-metabolic risk factors(12 months)
  • Clinically meaningful reductions in risk factors(12 months)
  • Percentage of patients attaining multiple treatment goals(12 months)
  • Satisfaction survey by participants(12 months)
  • Change in negative emotions(12 months)
  • Change in depressive symptom(12 months)

研究者

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

Junmei YIN

Ms.

Chinese University of Hong Kong

研究点 (2)

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