SMARTHealth Diabetes in China Using Lay Family Health Promoters

Study Overview
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Brief Summary
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It's a community-based parallel-arm cluster Randomized Controlled Trial (RCT). An interactive mobile health management system will be developed to support lay family health promoters and healthcare staff to improve clinical outcomes for family members with Type 2 Diabetes Mellitus (T2DM). 2,000 participants from 80 sites will be chosen from urban (40 communities) and rural (40 villages) settings in Shijiazhuang City, Hebei Province.

Detailed Description
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Study design and Settings: Cluster randomised controlled trial involving 80 sites (40 communities in urban Shijiazhuang and 40 villages in rural Shijiazhuang) and 2,000 people with T2DM. Hypothesis: An interactive mobile health management system can support lay family health promoters (FHP) and healthcare staff to improve clinical outcomes for family members with T2DM Intervention: SMARTHealth Diabetes is an interactive mobile health platform to promote improved self-management for people with T2DM. It comprises the following core features: Management support based on best practice clinical guidelines Self-management tools and resources for family members Password protected registration of patients and their nominated FHP to access this information Population of key clinical information into a desktop application used by health care providers when applicable Community eligibility: 40 urban communities and 40 rural villages from geographically dispersed regions will be selected Each community/ village must have at least one community health station providing services to ≥1,000 adult residents Staff at the community health station must be willing to participate in the intervention Statistical power: 80 clusters and a mean community cluster size of 25 participants (2,000 total) will provide 90% power to detect an absolute improvement of 10% in the primary outcome. This assumes 20% of people in the control arm will achieve ≥2 'ABC' diabetes goals ((HbA1C<7%; Blood Pressure <140/80 mmHg, LDL cholesterol <100mg/dl or 2.6mmol/L) at end of study; an intra-class correlation coefficient of 0.05, a 20% loss to follow-up, and a 2-sided significance level of 0.05. This translates to a mean reduction of 0.35% for HbA1C, 0.14 mmol/L for LDL cholesterol and 3.4mmHg for systolic BP. Primary analyses will be conducted at the patient level. Secondary analyses will be conducted at the cluster level. Sub-group analyses will be conducted at the community level (based on size and health service characteristics) and patient level (based on demographic factors (co-habitation with FHP) and clinical factors (control rate of 'ABC' risk factors at baseline). Significance: The Chinese government has placed prevention and treatment of diabetes as one of 11 National Basic Public Health Services. Despite great promise for mobile health (mHealth) interventions to improve access to effective healthcare, there remains uncertainty about how this can be successfully achieved. These uncertainties pose substantial dilemmas for health system planners. The findings are likely to inform policy on a scalable strategy to overcome sub-optimal access to effective health care in China.

Official Title
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Systematic Medical Assessment, Referral and Treatment for Diabetes Care in China Using Lay Family Health Promoters

Conditions
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Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias

Intervention / Treatment
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* Behavioral: SMARTHealth Diabetes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established T2DM HbA1C >= 7% Nominated family member with mobile internet access who agrees to be a family health promoter (FHP) Able to provide informed consent Exclusion Criteria: Psychologically or physically unable to participate the trials.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Participants in intervention communities will receive the SMARTHealth Diabetes intervention that connects community health service centers and family health providers for diabetes management. Medical staff and FHPs in the intervention communities will be provided with an initial training session on the installation and use of the platform. | Behavioral: SMARTHealth Diabetes<br>* SMARTHealth Diabetes is an interactive mobile health platform to promote improved self-management for people with T2DM.<br>|
| No Intervention: Control arm<br>Control group doesn't use SMARTHealth Diabetes.The usual-care in our study will be conducted in a standard way which is defined in the Guidance of National Essential Public Health Service. All the relevant doctors in control group will be trained and required to record the activities defined in the guidance. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving at least two ABC goals | The proportion of patients achieving at least two ABC goals defined as any two of the following: HbA1c <7.0%, blood pressure (BP) <140/80mmHg and LDL cholesterol <100mg/dl or 2.6mmol/L) at 24 months | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving the A goal | The proportion of patients achieving HbA1c <7.0% at 24 months | 24 months | 
| The proportion of patients achieving the B goal | The proportion of patients achieving blood pressure (BP) <140/80mmHg at 24 months | 24 months | 
| The proportion of patients achieving the C goal | The proportion of patients achieving LDL cholesterol <100mg/dl or 2.6mmol/L at 24 months | 24 months | 
| The proportion of patients achieving FPG<7.0 mmol/L | The proportion of patients achieving FPG<7.0 mmol/L at 24 months | 24 months | 
| Mean change in HbA1c level | Mean change in HbA1c level from baseline to 24 months | 24 months | 
| Mean changes in systolic and diastolic blood pressure levels | Mean changes in systolic and diastolic blood pressure levels from baseline to 24 months | 24 months | 
| Mean change in LDL cholesterol level | Mean change in LDL cholesterol level from baseline to 24 months | 24 months | 
| Mean change in FPG level | Mean change in FPG level from baseline to 24 months | 24 months | 
| Mean change in the Summary of Diabetes Self-Care Activities (SDSCA) from baseline to 24 month | The Summary of Diabetes Self-Care Activities is a scale to measure patients' self-management. The minimum value of each scale item is 0 and the maximum value is 7. Higher scores mean a better outcome. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Diabetes Mellitus, Type 2, Decision Support Systems, Clinical, Family Health Promoter, Primary Health Care