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Construction of the Shared Medical Appointment for Diabetes (SMART) in China: an Optimization Trial

Construction of the Shared Medical Appointment for Diabetes (SMART) in China: an Optimization Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069904
Enrollment
Unknown
Registered
2023-03-29
Start date
2023-04-15
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes

Interventions

optimization phase condition 1:The intervention consists of 3 components, which are: Component 1: Clinician and healthcare manager work together to provide services to patients once a month, with at l
the group size was two or more. Component 3: The clinician provides patients with a unique topic of health education prescriptions and explanations during each clinic consultation session.Three time
condition 2:The intervention consists of 3 components, which are: Component 1: Clinician and healthcare manager work together to provide services to patients once a month, with at least three times of

Sponsors

School of Public Health, Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Institutions: The trial targets primary healthcare institutions in Bozhou and Bijiang, distinct from Bozhou and Tongren cities, in the pilot trial. In the full optimization trial, institutions in six included cities or in other cities that are eligible to participate. These institutions are referred to as community healthcare centers in the urban areas and township healthcare centers in the rural areas. Those centers, comprising both public and private entities, serve as the primary providers of the government's diabetes management program, typically through government service contracts. After the pilot trial, we supplemented the following inclusion criteria: (1) The institution has at least two general or internal medicine clinics, one of which can be switched to a SAM-formed clinic. (2) Willing to provide the SMA service at least once a week for PWD; (3) Be able to complete the testing of patients' HbA1c and lipid profiles in their own institution or be able to send blood samples to the testing center to complete the testing. 2. Providers: These centers typically employ clinical doctors and public healthcare managers (i.e., SMA service providers) responsible for executing the government's diabetes program. Clinical doctors are clinically trained and focus on curative care and brief verbal health education, usually in outpatient settings. Our trial intends to recruit all doctors involved in the government diabetic program. On the other hand, public healthcare managers are usually trained in public health and perform disease management tasks. Their responsibilities typically include routine home-based follow-ups to test glucose levels and blood pressure, check symptoms (and make referrals when necessary), provide health education, and monitor patients' medication status. 3. Patients: Our trial will include individuals who (1) are currently enrolled in the government's diabetes management program at the sampled institutions (people meeting the national diagnostic criteria for T2DM , those whose HbA1c was more than 7.0% in the past half year, the age are equal to or older than 18 years old are eligible for the program), and (2) reside in the community and have no plans for relocation in the coming six months. 4. Other stakeholders: In addition to clinicians and patients, the following stakeholders will be invited to participate in the qualitative portion of the trial: government policy-makers, health institution managers, other clinicians who play a supportive role in team-based SMA care delivery, and relatives or friends of the patients. Stakeholders who rejected respondents will be excluded.

Exclusion criteria

Exclusion criteria: 1. SMA providers who refuse to participate in the SMA trial will be excluded. 2. Patient participants: People with cognitive and physical disabilities that prevent participation in the group clinical consultation will be excluded. The cognitive status will be assessed using the Chinese Mini-Mental State Examination (C-MMSE), with patients scoring 23 or lower being excluded. Participants will be asked about any physical limitations that prevent them from coming to the clinic individually, and those who report such constraints or refuse to participate will be excluded. 3. Stakeholders who rejected respondents will be excluded.

Design outcomes

Primary

MeasureTime frame
hemoglobin A1c;

Secondary

MeasureTime frame
fasting glucose (PrePrandial Glucose);PostPrandial Glucose;blood pressure;lipid;Chinese Mini-Mental State Examination (C-MMSE);the Chinese version of the Diabetes Management Self-efficacy Scale (C-DMSES);food frequency questionnaire (FFQ);Demand-side perspective of PCC service quality (PPPC-CN);body mass index (BMI);waist-hip ratio (WHR);36-item or 12-item short-form survey (SF-36);brief medication questionnaire (BMQ);Organizational Readiness of Implementing Evidence-based Practices Scale;evidence based practice capability assessment;patient-centerd care assessment;quality of medical care and health management assessment;Checklist for institutions to implement and finalize SMA;The completion of quality of care and health management checklist;Chinese Doctor-Patient Trust Scale (Doctor side Scale);

Countries

China

Contacts

Public ContactYiyuan Cai

School of Public Health, Guizhou Medical University

caiyiyuan@gmc.edu.cn+86 153 2900 9316

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026