SMARTHealth Diabetes in China Using Lay Family Health Promoters

Not Applicable

Completed

• Conditions: Hypertension; Dyslipidemias; Diabetes Mellitus, Type 2
• Interventions: Behavioral: SMARTHealth Diabetes

• Registration Number: NCT02726100
• Lead Sponsor: The George Institute for Global Health, China

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.

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 Timeline

• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-03-27
• Study First Posted: 2016-04-01
• Study Start: 2017-08-01
• Primary Completion: 2019-10-19
• Study Completion: 2021-02-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2073

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	SMARTHealth Diabetes	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 changes in systolic and diastolic blood pressure levels	24 months	Mean changes in systolic and diastolic blood pressure levels from baseline to 24 months
The proportion of patients achieving the "A" goal	24 months	The proportion of patients achieving HbA1c \<7.0% at 24 months
Mean change in HbA1c level	24 months	Mean change in HbA1c level 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.

Trial Locations

Locations (2)

Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Center of Disease Control and Prevention, Luquan; 🇨🇳 Shijiazhuang, Hebei, China