Self-care Management Programme for Type 2 Adult DM Patients With Poor Glycemic Control

NCT ID: NCT04092023

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2019-09-01

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control group

Participants in control group will be received usual care. They will be gone through yearly DM complication screening. A screening report and information sheet on general DM management will be issued to participants. Therapeutic goals will be set and further conventional health care education intervention will be referred.

Group Type: OTHER

nursing education

Intervention Type: OTHER

Participants will be recruited to attend 2 group sessions; each group will have 10-12 participants and each session will be lasted for 120 minutes. Two subsequent phones follow up to participants will be arranged.

Intervention group

The interventions are designed to address the seven key self-management behaviours identified by the Association of American Diabetes Educations: (1) healthy eating, (2) being active, (3) monitoring, (4) taking medication, (5) problem solving, (6) reducing risk, and (7) healthy coping. In addition, the Chronic Care Model elements of self-management support and patient centered-care approach is embraced during the intervention process. The nursing care components provided to participants will be included (a) self-care management knowledge, (b) skill-based learning and problem solving, (c) participants' participation and engagement, (d) participants' in goal setting, and (e) coordinate care, involve participants to make decision.

Group Type: OTHER

nursing education

Intervention Type: OTHER

Participants will be recruited to attend 2 group sessions; each group will have 10-12 participants and each session will be lasted for 120 minutes. Two subsequent phones follow up to participants will be arranged.

Interventions

nursing education

Participants will be recruited to attend 2 group sessions; each group will have 10-12 participants and each session will be lasted for 120 minutes. Two subsequent phones follow up to participants will be arranged.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Chan Ching Yee

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ching Y Chan

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

KWC FM & PHC, Hospital Authority

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

ChanCY_RP1

Identifier Type: -

Identifier Source: org_study_id