SMARTHealth Diabetes in China Using Lay Family Health Promoters
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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:
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Management support based on best practice clinical guidelines
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Self-management tools and resources for family members
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Password protected registration of patients and their nominated FHP to access this information
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Population of key clinical information into a desktop application used by health care providers when applicable
Community eligibility:
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40 urban communities and 40 rural villages from geographically dispersed regions will be selected
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Each community/ village must have at least one community health station providing services to ≥1,000 adult residents
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention arm 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
SMARTHealth Diabetes is an interactive mobile health platform to promote improved self-management for people with T2DM.
|
| No Intervention: Control arm 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. |
Outcome Measures
Primary Outcome Measures
- The proportion of patients achieving at least two "ABC" goals [24 months]
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
Secondary Outcome Measures
- The proportion of patients achieving the "A" goal [24 months]
The proportion of patients achieving HbA1c <7.0% at 24 months
- The proportion of patients achieving the "B" goal [24 months]
The proportion of patients achieving blood pressure (BP) <140/80mmHg at 24 months
- The proportion of patients achieving the "C" goal [24 months]
The proportion of patients achieving LDL cholesterol <100mg/dl or 2.6mmol/L at 24 months
- The proportion of patients achieving FPG<7.0 mmol/L [24 months]
The proportion of patients achieving FPG<7.0 mmol/L at 24 months
- Mean change in HbA1c level [24 months]
Mean change in HbA1c level from baseline to 24 months
- Mean changes in systolic and diastolic blood pressure levels [24 months]
Mean changes in systolic and diastolic blood pressure levels from baseline to 24 months
- Mean change in LDL cholesterol level [24 months]
Mean change in LDL cholesterol level from baseline to 24 months
- Mean change in FPG level [24 months]
Mean change in FPG level from baseline to 24 months
- Mean change in the Summary of Diabetes Self-Care Activities (SDSCA) from baseline to 24 month [24 months]
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.
Other Outcome Measures
- Mean change in body mass index (BMI) [24 months]
Mean change in body mass index (BMI) from baseline to 24 months
- Mean change in waist circumstance (WC) [24 months]
Mean change in waist circumstance (WC) from baseline to 24 months
- Mean change in the European quality of life 5 dimensions 3 levels scale (EQ-5D-3L) index value [24 months]
Mean change in the European quality of life 5 dimensions 3 levels scale (EQ-5D-3L) index value from baseline to 24 months. The minimum value of the scale is 0 and the maximum value is 1. Higher scores mean a better outcome.
- Mean change in the European quality of life overall self-rated visual analogue scale (EQ-VAS) [24 months]
Mean change in the European quality of life overall self-rated visual analogue scale (EQ-VAS) from baseline to 24 months. The minimum value of the scale is 0 and the maximum value is 100. Higher scores mean a better outcome.
- Mean change in The Summary of Diabetes Self-Care Activities (SDSCA) from baseline to 24 months [24 months]
Pending
- Mean change in urine albumin creatinine ratio (ACR) [24 months]
Mean change in urine albumin creatinine ratio (ACR) from baseline to 24 months
- Mean change in estimated glomerular filtration rate (GFR) [24 months]
Mean change in estimated glomerular filtration rate (GFR) from baseline to 24 months
Eligibility Criteria
Criteria
Inclusion Criteria:
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Established T2DM
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HbA1C >= 7%
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Nominated family member with mobile internet access who agrees to be a family health promoter (FHP)
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Able to provide informed consent
Exclusion Criteria:
Psychologically or physically unable to participate the trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hebei Medical University | Shijiazhuang | Hebei | China | 050017 |
| 2 | Center of Disease Control and Prevention, Luquan | Shijiazhuang | Hebei | China | 050200 |
Sponsors and Collaborators
- The George Institute for Global Health, China
- Global Alliance for Chronic Diseases (GACD)
- National Health and Medical Research Council, Australia
Investigators
- Principal Investigator: Puhong Zhang, PhD, The George Institute for Global Health at Peking University Health Science Center
- Principal Investigator: David Peiris, PhD, The George Institute for Global Health, University of Sydney
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APP1094712