Culturally Appropriate Strategies for Chinese Americans With Diabetes (CASCADe)

Type 2 Diabetes Clinical Trial

Official title:

Implementation and Evaluation of A Culturally Tailored Diabetes Self-Management Program for Chinese Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04737499
• Other study ID #: CGU IRB#2522
• Status: Completed
• Phase: N/A
• Start date: July 5, 2016
• Est. completion date: March 20, 2018

Study information

• Verified date: January 2021
• Source: Claremont Graduate University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project aimed to evaluate the implementation process and efficacy of a culturally tailored Diabetes Self-Management and Education (DSME) program with mobile health (mHealth) technology integration, entitled Culturally Appropriate Strategies for Chinese Americans with Diabetes (CASCADe), among Chinese American adults with Type 2 diabetes.

Description:

The CASCADe program includes 1) a home visit for training of monitoring devices use, WeChat app and acquiring family support, 2) 8 weekly education sessions with a combined format of group class, games, food demonstration, group exercise, video and discussion, 3) WeChat follow-up on education tips, monitoring data summary, and group discussion. The monitoring system used a smartphone to coordinate cloud data transmission from a set of wireless devices to capture daily monitoring data on physical activity, body weight, blood pressure and blood glucose levels. WeChat app was used to facilitate behavioral self-monitoring by providing daily messages related to diabetes education curriculum, weekly summary reports on monitoring data as well as reinforcement messages and group discussion on readings and monitoring results implication. A single group pre-post-test design was adopted to evaluate changes of primary (HbA1c) and secondary (Self-efficacy, quality of life and stress coping) outcomes assessed at pre and post of intervention. Engagement and adherence in education sessions and self-monitoring system, and satisfaction with the content and delivery of intervention were also evaluated at the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 20, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• have been diagnosed with Type 2 diabetes

• having been managing diabetes with diet, oral hypoglycemic agents or insulin, or both

• confirmed HbA1c level >=6.5% and <10%

• 21-75 years old

• residents of San Gabriel Valley

• speak and understand of Mandarin

• willing to use the smartphone-based monitoring devices provided by the project.

Exclusion Criteria:

• unable or unwilling to give informed consent

• plan to move out of the area within the 1-year participation study period

• are or plan to be pregnant or breastfeeding in the next 12 months

• have a condition that inhibits movement (e.g., unable to walk unaided, or cannot walk 1/4 mile without stopping)

• have major physical disability or condition that prevents them from participating in person.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• CASCADe
Culturally tailored diabetes self-management and education sessions with mHealth integration

Locations

Country	Name	City	State
United States	Clarement Graduate University	Claremont	California

Sponsors (2)

Lead Sponsor	Collaborator
Claremont Graduate University	AHMC Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Concentration of HbA1c	HbA1c was assessed using the testing kit of A1C Now+ with a finger prick of blood by trained data collector.	Change from baseline HbA1c at 3 months
Secondary	Change of Score of Self-efficacy	Chinese version of diabetes self-management self-efficacy scale included 20 items with likert-like response scale of 1-5 and minimum score of 20 and maximum score of 100.	Change from baseline Self-efficacy score at 3 months
Secondary	Change of Score of Quality of life	Chinese version of diabetes quality of life scale included 15 items with likert-like response scale of 1-5, and minimum score of 15 and maximum score of 75. .	Change from baseline Quality of life score at 3 months