This is a prospective, randomized, parallel, multicenter controlled study to evaluate the effectiveness of the general practitioners and diabetes specialists co-management model for type 2 diabetes. Patients with type 2 diabetes will be randomized to participate in the community general practitioners and diabetes specialists management or serve as controls continuing with routine primary health care. The primary outcome is to observe the HbA1c change.
Aim: This study constructs a general practitioner and diabetes specialist co-management model for patients with type 2 diabetes in the community based on the integration of prevention and treatment strategies. Also, the effectiveness of the model will be evaluated by a parallel randomized controlled trial design to provide theoretical support and empirical evidence for the development of a comprehensive management strategy for patients with type 2 diabetes. Hypothesis: Compared to the control group, the intervention group receiving co-management by general practitioners and diabetes specialists has a greater improvement in HbA1c, fasting glucose, blood pressure, lipids, BMI, diabetes self-management ability, depression symptoms, diabetes distress, and diabetes complications-related indicators. Recruiting: This study will recruit patients with type 2 diabetes who have established electronic health records in 5 community healthcare centers affiliated with the Baoan Central Hospital of Shenzhen. General practitioners at the community healthcare centers screen patients with type 2 diabetes under their care who are eligible for the study based on the inclusion and exclusion criteria. Following face-to-face communication, general practitioners explain the study objectives and procedures to patients and obtain their informed consent. Before the start of the study, unified training will be conducted for the general practitioners involved in the recruitment so that they can clarify the inclusion and exclusion criteria, screening methods, and precautions regarding the study objects. Randomization Procedure: Members of the research team served as the grouping scheme controllers of the randomization center. The Proc plan procedure of SAS 9.4 statistical software was used to generate random number sequences and grouping schemes according to a 1:1 assignment. For the patients with type 2 diabetes who met the inclusion and exclusion criteria, general practitioners contacted randomization center staff members by telephone according to the patients' order of arrival at the community healthcare center and informed them of the patient's name and ID number. Then the randomization center staff recorded patient information, numbered the patients, and divided them into an intervention group or control group according to the previously generated random number table. Finally, the randomization center staff informed patients' general practitioners of their grouping results. Study design: The study includes three phases: baseline, intervention, and follow-up. All participants will be divided into an intervention group and a control group after completing the baseline survey. The implementation phase of the intervention will last 18 months. Patients in the intervention group will have daily blood glucose monitoring with a smart home blood glucose meter. Each patient will be assigned a dedicated general practitioner to track the patient's blood glucose monitoring results. Based on the remote monitoring of blood glucose and HbA1c tests, general practitioners and specialists will jointly carry out management measures including health education, medication adjustment, outpatient consultation, referral, and case discussion for participants. The control group will be routinely treated and followed up by general practitioners according to Chinese clinical guidelines and national norms for basic public health services. Data collection and management: baseline and follow-up data were collected using questionnaires and physical examination record forms. The collected data was entered into Epidata software and imported into Statistical Analysis System (SAS) 9.4 for analysis. After the end of the experiment, the data will be stored in the database of our research group for a long time.
Self-monitoring of blood glucose: Participants will monitor blood glucose with a a free intelligent home blood glucose meter. Then, the intelligent blood glucose meter will upload data to the platform. Glycosylated hemoglobin check: Cooperative General Practitioner-Specialist Management: Based on the remote monitoring of blood glucose, general practitioners and specialists will jointly carry out management measures including health education, medication adjustment, outpatient consultation, referral, case discussion, etc. for participants.
Baoan Central Hospital of Shenzhen
Shenzhen, Guangdong, China
HbA1c change
The change of HbA1c during the study. The level of HbA1c in blood measured in %.
Time frame: Baseline, 6, and 18 months
Fasting Plasma Glucose
The change of HbA1c during the study.
Time frame: Baseline, 6, and 18 months
Total cholesterol
The change of total cholesterol during the study.
Time frame: Baseline, 6, and 18 months
Triglycerides
The change of total triglycerides during the study.
Time frame: Baseline, 6, and 18 months
LDL-C
The change of LDL-C during the study.
Time frame: Baseline, 6, and 18 months
HDL-C
The change of LDL-C during the study.
Time frame: Baseline, 6, and 18 months
Blood pressure
The change of blood pressure during the study.
Time frame: Baseline, 6, and 18 months
Body Mass Index (BMI)
The change of BMI during the study.
Time frame: Baseline, 6, and 18 months
Diabetes self-care activities
Diabetes self-care activities will be measured by the Summary of Diabetes Self-Care Activities (SDSCA) scale. The SDSCA scale measures the frequency of performing diabetes self-care activities, including diet, exercise, blood glucose testing, foot care, and tobacco use over the past 7 days. SDSCA comprises of 11 items and each item's response is rated on 7 point scale ranging from '0' to '7' . A higher score would be the frequency of performing self-care activities.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
609
Time frame: Baseline, 6, and 18 months
Diabetes distress
Diabetes distress scores will be measured by the Problem Areas In Diabetes (PAID). The scale ranges from a minimum of 0 (not a problem) to a maximum score of 4 (serious problem). The sum of the five questions provides the participant's score with a score range of minimum score of 0 to a maximum score of 20. A total score of greater than or equal to 8 indicates possible diabetes related emotional distress, with a higher score indicating more significant distress.
Time frame: Baseline, 6, and 18 months
Depressive symptoms
Depressive symptoms will be assessed by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item scale where respondents indicate how much they are bothered by certain problems on a 4-point scale where 0 = not at all and 3 = nearly every day. Total scores range from 0 to 27 with degree of depression considered minimal for scores between 0-4, mild for scores of 5-9, moderate for scores of 10-14, moderate to severe for scores 15-19, and severe for scores of 20-27.
Time frame: Baseline, 6, and 18 months
Self-Efficacy
Participants' self-efficacy level will be measured by the Diabetes Empowerment Scale (DES-SF). The scale consists of 10 items and reports in a 5-points Likert scale. An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 points. Minimum score is 8, max is 40. Higher scores indicate greater sense of empowerment to self-manage condition.
Time frame: Baseline, 6, and 18 months