SMARTHealth Diabetes in China Using Lay Family Health Promoters

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726100
• Other study ID #: APP1094712
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: The George Institute for Global Health, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2073
• Est. completion date: February 28, 2021
• Est. primary completion date: October 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemias
• Hypertension

Intervention

Behavioral:
• SMARTHealth Diabetes
SMARTHealth Diabetes is an interactive mobile health platform to promote improved self-management for people with T2DM.

Locations

Country	Name	City	State
China	Center of Disease Control and Prevention, Luquan	Shijiazhuang	Hebei
China	Hebei Medical University	Shijiazhuang	Hebei

Sponsors (3)

Lead Sponsor	Collaborator
The George Institute for Global Health, China	Global Alliance for Chronic Diseases (GACD), National Health and Medical Research Council, Australia

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean change in body mass index (BMI)	Mean change in body mass index (BMI) from baseline to 24 months	24 months
Other	Mean change in waist circumstance (WC)	Mean change in waist circumstance (WC) from baseline to 24 months	24 months
Other	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
Other	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
Other	Mean change in The Summary of Diabetes Self-Care Activities (SDSCA) from baseline to 24 months	Pending	24 months
Other	Mean change in urine albumin creatinine ratio (ACR)	Mean change in urine albumin creatinine ratio (ACR) from baseline to 24 months	24 months
Other	Mean change in estimated glomerular filtration rate (GFR)	Mean change in estimated glomerular filtration rate (GFR) from baseline to 24 months	24 months
Primary	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	The proportion of patients achieving the "A" goal	The proportion of patients achieving HbA1c <7.0% at 24 months	24 months
Secondary	The proportion of patients achieving the "B" goal	The proportion of patients achieving blood pressure (BP) <140/80mmHg at 24 months	24 months
Secondary	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
Secondary	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
Secondary	Mean change in HbA1c level	Mean change in HbA1c level from baseline to 24 months	24 months
Secondary	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
Secondary	Mean change in LDL cholesterol level	Mean change in LDL cholesterol level from baseline to 24 months	24 months
Secondary	Mean change in FPG level	Mean change in FPG level from baseline to 24 months	24 months
Secondary	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