Effects of a Self-care Management Programme for Type 2 Adult Diabetic Patients With Poor Glycemic Control in General Out-patients Clinics - a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Glycemic control
研究概览
简要总结
Type 2 diabetes becomes the most prevalence chronic disease worldwide. Most type 2 diabetes patient are under the care in public general out-patient clinic in Hong Kong. The chronic nature of diabetic and the complexity of its management, on top of medication, diabetic patients often require behaviour modification and self-care management support. Effective diabetes self-care management education with patient-centered care approach with patients' participation and engagement has been shown to improve the clinical outcome. But such application during doctors' consultation are minimal in view of time limitation. Primary Care Nurse (PCN) is the first contact and is easily accessible in GOPCs. With support and training, PCN could act as a case manager to deliver the coordinated care. Interact and engage type 2 diabetes patients in self-care management, and work with multidisciplinary team in providing patient-centered care in GOPC setting. As there is lack of evidence about adopting such approach in the investigator's local population. This study is to test the effectiveness of the PCN led self-care management program to improve patients' clinical outcomes.
详细描述
- Safety Assessment
There is no harmful effect from the intervention. 2. Statistics
(A) Sample Size Estimation With reference from previous study (Aanand et al. 2011), the sample size is calculated by assuming change the reduction of HbA1c is 0.59% (intervention group 8.05% (SD 1.40) versus control group 8.64% (SD 1.39). In order to have 80% power and 5% false positive error, a sample size of 88 is needed for each arm using the public domain sample size calculator (https://www2.ccrb.cuhk.edu.hk/stat/). After consideration of 10% attrition rate, 97 participants will be recruited in each arm.
(B) Data Analysis All statistical analyses will be performed using SPSS Windows 22.0 program. P-value less than 0.05 will be considered statistically significant. All treatment evaluations will be performed on the principle of intention-to-treat analysis of the difference in outcomes between groups at 6 months after baseline. Missing values will be imputed using last value carrying forward method. Repeated analysis will be done for per-protocol analysis. Demographics and baseline characteristics will be summarized using descriptive statistics. Continuous variable will be summarized as numbers of observed values, mean and standard deviation. Categorical variables will be described as frequency and percentage. Information collected on all outcomes will be first summarized using descriptive statistics at baseline and at 6 months as appropriate. Linear regression model will be used to test the effect of intervention on the outcomes between 2 groups. 3. Direct Access to Source Data and Documents
Apart from the outpatient number and Initials, no subject sensitive identifier will be contained in the completed questionnaires. All completed questionnaires will be kept in knocked administrative room in research site with limited access by investigators. All patient records in CMS will be accessed by investigators only by their own CMS login. 4. Quality Control and Quality Assurance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Clinically diagnosed of type 2 diabetes
- •Poorly glycemic control with recent HbA1c ≧ 7.5%
- •Chinese participants who could speak Cantonese
排除标准
- •Unable to perform self-care management due to physical or mental limitation
- •Engage in another similar program
- •Life expectancy <1 year due to malignancies or other terminal illness
结局指标
主要结局
Glycemic control
时间窗: Assess change from Baseline HbA1c at 6 months
Blood test for HbA1c
次要结局
- QOL: Audit of Diabetes Dependent Quality of Life (ADDQoL-19)(Assess change from Baseline HbA1c at 6 months)
- Self-Efficacy: Diabetes Empowerment Scale - Short Form (C-DES-SF)(Assess change from Baseline HbA1c at 6 months)
- Diabetes Knowledge(Assess change from Baseline HbA1c at 6 months)
研究者
Chan Ching Yee
Principal Investigator
Chinese University of Hong Kong