SMARTHealth Diabetes in China Using Lay Family Health Promoters

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

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 Overview

• Status: Completed
• Conditions: Hypertension; Diabetes Mellitus, Type 2; Dyslipidemias
• Intervention / Treatment: Behavioral: SMARTHealth Diabetes

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:

• 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.

• Study Type: Interventional
• Enrollment (Actual): 2073
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050017
      • Hebei Medical University
    • Shijiazhuang, Hebei, China, 050200
      • Center of Disease Control and Prevention, Luquan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in body mass index (BMI)	Mean change in body mass index (BMI) from baseline to 24 months	24 months
Mean change in waist circumstance (WC)	Mean change in waist circumstance (WC) from baseline to 24 months	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.	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.	24 months
Mean change in The Summary of Diabetes Self-Care Activities (SDSCA) from baseline to 24 months	Pending	24 months
Mean change in urine albumin creatinine ratio (ACR)	Mean change in urine albumin creatinine ratio (ACR) from baseline to 24 months	24 months
Mean change in estimated glomerular filtration rate (GFR)	Mean change in estimated glomerular filtration rate (GFR) from baseline to 24 months	24 months

Collaborators and Investigators

• Sponsor: The George Institute for Global Health, China
• Collaborators: National Health and Medical Research Council, Australia; Global Alliance for Chronic Diseases (GACD)
• 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

Publications and helpful links

General Publications

• Peiris D, Sun L, Patel A, Tian M, Essue B, Jan S, Zhang P. Systematic medical assessment, referral and treatment for diabetes care in China using lay family health promoters: protocol for the SMARTDiabetes cluster randomised controlled trial. Implement Sci. 2016 Aug 17;11(1):116. doi: 10.1186/s13012-016-0481-8.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): October 19, 2019
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: March 27, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; Primary Health Care; Diabetes Mellitus, Type 2; Decision Support Systems, Clinical; Family Health Promoter
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias
• Other Study ID Numbers: APP1094712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data are only accessed by investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No