An interventional study of SMARTHealth Diabetes in Diabetes Mellitus, Type 2, Hypertension and Dyslipidemias, sponsored by The George Institute for Global Health, China. Completed at 2 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-12.
Sponsored by The George Institute for Global Health, China · Not applicable, Interventional, and Health services research
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.
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:
Community eligibility:
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 2,073 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →The George Institute for Global Health, China is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Psychologically or physically unable to participate the trials.
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
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.
SMARTHealth Diabetes is an interactive mobile health platform to promote improved self-management for people with T2DM.
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
Time frame: 24 months
The proportion of patients achieving the "A" goal
The proportion of patients achieving HbA1c \<7.0% at 24 months
Time frame: 24 months
The proportion of patients achieving the "B" goal
The proportion of patients achieving blood pressure (BP) \<140/80mmHg at 24 months
Time frame: 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
Time frame: 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
Time frame: 24 months
Mean change in HbA1c level
Mean change in HbA1c level from baseline to 24 months
Time frame: 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
Time frame: 24 months
Mean change in LDL cholesterol level
Mean change in LDL cholesterol level from baseline to 24 months
Time frame: 24 months
Mean change in FPG level
Mean change in FPG level from baseline to 24 months
Time frame: 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.
Time frame: 24 months
Mean change in body mass index (BMI)
Mean change in body mass index (BMI) from baseline to 24 months
Time frame: 24 months
Mean change in waist circumstance (WC)
Mean change in waist circumstance (WC) from baseline to 24 months
Time frame: 24 months
Mean change in the European quality of life 5 dimensions 3 levels scale (EQ-5D-3L) index value
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.
Time frame: 24 months
Mean change in the European quality of life overall self-rated visual analogue scale (EQ-VAS)
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.
Time frame: 24 months
Mean change in The Summary of Diabetes Self-Care Activities (SDSCA) from baseline to 24 months
Pending
Time frame: 24 months
Mean change in urine albumin creatinine ratio (ACR)
Mean change in urine albumin creatinine ratio (ACR) from baseline to 24 months
Time frame: 24 months
Mean change in estimated glomerular filtration rate (GFR)
Mean change in estimated glomerular filtration rate (GFR) from baseline to 24 months
Time frame: 24 months
Plan to share: No — Data are only accessed by investigators.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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The George Institute for Global Health, China