Clinical trial NCT04092023: Self-care Management Programme for Type 2 Adult DM Patients With Poor Glycemic Control
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A six month and two-arm parallel randomized control trial is employed
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 1. 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

   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.

Eligibility criteria: Inclusion Criteria:

1. Aged \>=18
2. Clinically diagnosed of type 2 diabetes
3. Poorly glycemic control with recent HbA1c ≧ 7.5%
4. Chinese participants who could speak Cantonese

Exclusion Criteria:

1. Unable to perform self-care management due to physical or mental limitation
2. Engage in another similar program
3. Pregnancy
4. Life expectancy \<1 year due to malignancies or other terminal illness

Primary outcomes:
measure: Glycemic control
timeFrame: Assess change from Baseline HbA1c at 6 months
Secondary outcomes:
measure: Diabetes Knowledge
timeFrame: Assess change from Baseline HbA1c at 6 months
measure: Self-Efficacy: Diabetes Empowerment Scale - Short Form (C-DES-SF)
timeFrame: Assess change from Baseline HbA1c at 6 months
measure: QOL: Audit of Diabetes Dependent Quality of Life (ADDQoL-19)
timeFrame: Assess change from Baseline HbA1c at 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: KWC FM & PHC, Hospital Authority
Study officials:
affiliation: Chinese University of Hong Kong
name: Ching Y Chan
role: PRINCIPAL_INVESTIGATOR
References: