Effectiveness of Shared Care Diabetes Management in Patients With Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Beijing Chao Yang Hospital
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- HbA1c change
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a prospective, randomization, parallel, controlled study to evaluate the effectiveness of Shared Care diabetes management. Patients with T2DM involved in the Shared Care model pay regularly quarterly visit to a multidisciplinary team led by physician at outpatient clinic, and receive remote patient management and education after going home. After at least 3 years follow-up, patients' metabolic indexes including HbA1c, LDL-c, blood pressure, diabetes self-management behavior indexes and diabetes complications are evaluated.
The primary goal is to observe the HbA1c levels and the HbA1c achieving rate. The secondary goal is to assess the diabetes self-management behavior change for patients of the Shared Care multidisciplinary diabetes care model and to assess the effect of online diabetes self-management support for patients of the Shared Care multidisciplinary diabetes care model.
Detailed Description
With population aging and increasing prevalence of obesity in China, the number of patients with diabetes mellitus, healthcare expenditure and mortality related to DM are forecast to grow substantially. 114 million diabetic patients and 11.6% incidence rate of diabetes yield enormous chronic disease management pressure. China medical resources are not sufficient for the great diabetes epidemic (1-5) . The data from a multicenter, cross-sectional survey of outpatients conducted in 606 hospitals across China showed that the majority of patients with type 2 diabetes did not achieve the goal of HbA1c \<7.0% (6). We are facing problems including inadequate patient education, unable to track the entire diabetic course, and the lack of effective patient engagement in-between clinic visits(1-5). Diabetes management and education can improve patients' quality of life, reduce incidence and mortality of diabetic complications and relieve the medical economy burden for the government. (7). International guidelines published by American Diabetes Association and the National Institute and Health and Care Excellence in Hong Kong imply that a chronic disease service delivery model that incorporates continuous follow-ups, DSMES (diabetes self-management education and support) with a multidisciplinary team of health professionals to provide ongoing treatments, patient education, and scheduled health assessments for monitoring of disease control and complications has promoted internationally as a more holistic and cost-effective way to manage patients with diabetes(8-12) . To help health professionals to improve medical efficiency and help patients develop healthy lifestyle, we established Shared Care diabetes management model and believe that it can provide a solution. Shared Care Model aims to empower patients with diabetes self-management education and supports (DSMES), achieve better health outcomes and delay incidence and mortality of diabetic complications. Compared with traditional diabetes outpatient settings, patients of Shared Care return to the hospital for regular follow-up every three months, and meet with a multidisciplinary team includes diabetes educators, nurses, dietitians and physical therapist led by the physician. The patients download the Shared Care mobile application during the outpatient service and connect with the smart-glucometer Bg1 to upload blood glucose dairy in real time. With patient's informed consent, his or her data from each visit will be collected and recorded for analysis. The internet, IOT (internet of Things) and other information technology enables the Shared Care model to integrate outpatient and remote patient management, online and face-to-face medical services and provide patients with comprehensive health care. Our health care extended beyond the hospital. After the patient returns home from the clinic, they can communicate through the APP with online diabetes educators. The educators answer patients' questions, give suggestions on patients' diet and summarize patients' issues to physicians, who provide high level supervision. The model enables both patients and medical team for real-time data sharing, smart analysis and remote monitoring which significantly improve management efficiency and release medical resources for more patients. The Shared Care program in our hospital was established since Jan. 2018. Until Jul. 2019, there are totally 1062 patients receiving continuous diabetes care which was provided by a multidisciplinary team. 82.8% patients are followed regularly every three months, the HbA1c achieving rate (\<7%) is 69.5% after 1-year follow-up. Patient's self-management behavior improves one year after admission. The study is aim to discover the influencing factors that affect the HbA1c achieving rate and the efficiency and effect of the new model Shared Care.
Investigators
Guang Wang
Professor and Director, Department of Endocrinology
Beijing Chao Yang Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with T2DM
- •Patients who have Informed and signed the consent form content
- •Patients can be regularly followed (every 3 months) for at least 3 years
Exclusion Criteria
- •Patients with important organ failure or other severe diseases including infection, mentally disorder, heart failure or disseminated intravascular coagulation
- •Patients with active or inactive malignant tumour, expectation of life less than 1 year
- •Patients with communication disorders, cannot communicate and/or cooperate
- •Females that are regnant, breast-feeding female, or conception plan in the recent year
Outcomes
Primary Outcomes
HbA1c change
Time Frame: through study completion, an average of 3 year
The change between baseline HbA1c and HbA1c 3 years after admission
Blood Pressure change
Time Frame: through study completion, an average of 3 year
The change between baseline blood pressure and blood pressure 3 years after admission
LDL-c change
Time Frame: through study completion, an average of 3 year
The change between baseline LDL-c and LDL-c 3 years after admission
Secondary Outcomes
- SDSCA(Summary of Diabetes Self Care Activities) score change(through study completion, an average of 3 year)
- A-DQOL(Amendment Diabetes Quality of Life scale) score change(through study completion, an average of 3 year)
- Morisky scale score change(through study completion, an average of 3 year)
- C-DMSES(Chinese Diabetes Management Self-Efficacy Scale) score change(through study completion, an average of 3 year)
- DASS-C21scale score change(through study completion, an average of 3 year)
- BMI change(through study completion, an average of 3 year)