Track topics on Twitter Track topics that are important to you
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.
1. Safety Assessment
There is no harmful effect from the intervention.
(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
Expert panel including family medicine specialist, diabetes nurse consultant, diabetes nurse working in primary health care setting, dietitian, physiotherapist and podiatry will review the education contents. Nurses who have received structural education on chronic disease management as organized by Institute of Advanced Nursing Studies, Hospital Authority will be assigned to provide intervention to participants. All the interventionist and co-investigator will be trained for 4 hours by principal investigator for the objectives, contents and process of program before implementation. Meeting will be held during the process of data collection to exchange ideas and knowledge between the interventionist.
Principal investigator will monitor in all study phase. The interaction between interventionists and participants will be guided by protocol and guideline. Co-investigator in individual clinic will monitor participants' recruitment and data collection. Principal investigator will randomly check and sit in to monitor the consistency.
5. Ethics and Data Handling
Ethics of this study will be complied with the Declaration of Helsinki. Investigators will explain the study in detail and subjects will sign an informed consent form with written information sheet. Investigators will clarify all the queries with subjects. The enrolment will be entirely voluntary and it will not affect their care received in the study site. All the personal identifiers will be removed during data processing. The relevant documents will be kept in a locked cabinet in the study site and will be retained for 3 years after the study end.
Type 2 Diabetes
KWC FM & PHC, Hospital Authority
Chinese University of Hong Kong
Published on BioPortfolio: 2019-09-23T04:51:49-0400
This is a study to examine if it is possible to fit a diabetes education program into the workflow of hospital nursing units for delivery at the bedside to individual diabetes patients and...
This is a prospective, randomized trial to evaluate the effectiveness of using educational modules accessed through a bedside tablet in patients newly diagnosed with Type 1 Diabetes as an ...
There is a research gap of integrating genomics into nursing practice, education and research. Nursing students seldom use genetic-genomic data for understanding the individuality of patie...
The needs of children and teens with type 1 diabetes are very specific and different from the adults with type 1 diabetes. Many organizations such as the World Health Organization or the I...
The goal of this randomized controlled trial is to determine if greater effectiveness can be achieved by the addition of lay-led self-management patient education to regular professionally...
Type 2 diabetes is a progressive condition and many people require insulin therapy 5-10 years post diagnosis. Considering the global increase in type 2 diabetes, group education programmes to initiat...
This systematic review and meta-analysis evaluated the effectiveness of diabetes self-management education (DSME) in reducing glycosylated hemoglobin (A1C) levels in adult Latinos with type 2 diabetes...
To assess the feasibility, acceptability, and preliminary efficacy of a culturally sensitive nurse-led structured education programme for patients with type 2 diabetes.
Some individuals with diabetes fast during Ramadan despite medical concerns for risk of adverse outcomes. The Managing Diabetes During Ramadan Conversation Map is a self-management education group-bas...
Diabetes mellitus is a major and growing medical problem, affecting patients of all ages worldwide. Diabetes education is an important component of diabetes treatment. The goals of diabetes education ...
A four-year program in nursing education in a college or university leading to a B.S.N. (Bachelor of Science in Nursing). Graduates are eligible for state examination for licensure as RN (Registered Nurse).
Use for general articles concerning nursing education.
A two-year program in nursing education in a community or junior college leading to an A.D. (Associate Degree). Graduates of this program are eligible for state examination for licensure as RN (Registered Nurse).
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
Those educational activities engaged in by holders of a bachelor's degree in nursing, which are primarily designed to prepare them for entrance into a specific field of nursing, and may lead to board certification or a more advanced degree.