Health literacy intervention on type 2 diabetes in China

Not Applicable

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN76130594
• Lead Sponsor: China Medical Board (CMB) (USA)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31891144 (added 02/01/2020) 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25527255

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-22
• Study Completion: 2016-12-31
• Last Update Posted: 21 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 799

Inclusion Criteria

1. Patient has a clinical diagnosis of type 2 diabetes
2. Age 18-85 years
3. Most recent HbA1c >=7.5%
4. Patient agrees to participate in the study for the full two years duration

Exclusion Criteria

1. Poor visual acuity (vision worse than 20/50 using Rosenbaum Pocket Screener)
2. Significant dementia, or psychosis (by health provider report or chart review)
3. Terminal illness with anticipated life expectancy < 2 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be changes in HbA1c at baseline and at 3, 6, 12, and 24 months of intervention. HbA1c level will be measured by a blood test.

Secondary Outcome Measures

Name	Time	Method
Other measures include self-care behaviors, blood pressure, cholesterol, and utilization of clinical services. Incremental costs per behavioral, biologic and QALY change will also be determined. This will be measured at baseline and at 3, 6, 12, and 24 months of intervention.