SMARTHealth Diabetes in China Using Lay Family Health Promoters

NCT02726100 | Completed DMC

• 1 other identifier: APP1094712
• Study Type: interventional
• Target: 2,073
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension; Dyslipidemias

Keywords

Telemedicine; Diabetes Mellitus, Type 2; Decision Support Systems, Clinical; Family Health Promoter; Primary Health Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The proportion of patients achieving the "A" goal

  24 months

• The proportion of patients achieving the "B" goal

  24 months

• The proportion of patients achieving the "C" goal

  24 months

• The proportion of patients achieving FPG<7.0 mmol/L

  24 months

• Mean change in HbA1c level

  24 months

Other Outcomes (7)

• Mean change in body mass index (BMI)

  24 months

• Mean change in waist circumstance (WC)

  24 months

• Mean change in the European quality of life 5 dimensions 3 levels scale (EQ-5D-3L) index value

  24 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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 arm

NO INTERVENTION

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.

Interventions

SMARTHealth Diabetes BEHAVIORAL

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

Intervention arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychologically or physically unable to participate the trials.

Sponsors & Collaborators

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

Study Sites (2)

Hebei Medical University

Shijiazhuang, Hebei, 050017, China

Location

Center of Disease Control and Prevention, Luquan

Shijiazhuang, Hebei, 050200, China

Location

Related Publications (2)

• Tao X, Mao L, Zhang P, Ma X, Liang Z, Sun K, Peiris D. Barriers and facilitators to primary care management of type 2 diabetes in Shijiazhuang City, China: a mixed methods study. BMC Prim Care. 2024 Mar 13;25(1):84. doi: 10.1186/s12875-024-02330-7.

  PMID: 38481166 DERIVED

• 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.

  PMID: 27535128 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 1, 2016
• Study Start: August 1, 2017
• Primary Completion: October 19, 2019
• Study Completion: February 28, 2021
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)