Clinical trial NCT02726100: SMARTHealth Diabetes in China Using Lay Family Health Promoters
Official title: Systematic Medical Assessment, Referral and Treatment for Diabetes Care in China Using Lay Family Health Promoters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Dyslipidemias
Keywords: Telemedicine
Diabetes Mellitus, Type 2
Decision Support Systems, Clinical
Family Health Promoter
Primary Health Care
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
Collaborators: name: Global Alliance for Chronic Diseases (GACD)
name: National Health and Medical Research Council, Australia
First posted: 2016-04-01
Enrollment: 2073
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients achieving at least two "ABC" goals
timeFrame: 24 months
Secondary outcomes:
measure: The proportion of patients achieving the "A" goal
timeFrame: 24 months
measure: The proportion of patients achieving the "B" goal
timeFrame: 24 months
measure: The proportion of patients achieving the "C" goal
timeFrame: 24 months
measure: The proportion of patients achieving FPG<7.0 mmol/L
timeFrame: 24 months
measure: Mean change in HbA1c level
timeFrame: 24 months
measure: Mean changes in systolic and diastolic blood pressure levels
timeFrame: 24 months
measure: Mean change in LDL cholesterol level
timeFrame: 24 months
measure: Mean change in FPG level
timeFrame: 24 months
measure: Mean change in the Summary of Diabetes Self-Care Activities (SDSCA) from baseline to 24 month
timeFrame: 24 months
Other outcomes:
measure: Mean change in body mass index (BMI)
timeFrame: 24 months
measure: Mean change in waist circumstance (WC)
timeFrame: 24 months
measure: Mean change in the European quality of life 5 dimensions 3 levels scale (EQ-5D-3L) index value
timeFrame: 24 months
measure: Mean change in the European quality of life overall self-rated visual analogue scale (EQ-VAS)
timeFrame: 24 months
measure: Mean change in The Summary of Diabetes Self-Care Activities (SDSCA) from baseline to 24 months
timeFrame: 24 months
measure: Mean change in urine albumin creatinine ratio (ACR)
timeFrame: 24 months
measure: Mean change in estimated glomerular filtration rate (GFR)
timeFrame: 24 months
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: Center of Disease Control and Prevention, Luquan
state: Hebei
Study officials:
affiliation: The George Institute for Global Health at Peking University Health Science Center
name: Puhong Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Institute for Global Health, University of Sydney
name: David Peiris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.