Clinical trial NCT04100278: Effectiveness of Shared Care Diabetes Management in Patients With Type 2 Diabetes
Official title: Effectiveness of Shared Care Diabetes Management in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes
Diabetes Education and Management
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomization, parallel, controlled study.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: HbA1c change
timeFrame: through study completion, an average of 3 year
measure: Blood Pressure change
timeFrame: through study completion, an average of 3 year
measure: LDL-c change
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: BMI change
timeFrame: through study completion, an average of 3 year
measure: SDSCA(Summary of Diabetes Self Care Activities) score change
timeFrame: through study completion, an average of 3 year
measure: C-DMSES(Chinese Diabetes Management Self-Efficacy Scale) score change
timeFrame: through study completion, an average of 3 year
measure: A-DQOL(Amendment Diabetes Quality of Life scale) score change
timeFrame: through study completion, an average of 3 year
measure: Morisky scale score change
timeFrame: through study completion, an average of 3 year
measure: DASS-C21scale score change
timeFrame: through study completion, an average of 3 year
Other outcomes:
measure: Diabetes complications
timeFrame: through study completion, an average of 3 year
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
Study officials:
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