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Culturally Appropriate Strategies for Chinese Americans With Diabetes (CASCADe)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CASCADe
Sponsored by
Claremont Graduate University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Chinese Americans, Type 2 Diabetes, mHealth, Diabetes Self-Management and Education

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clarement Graduate University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CASCADe Intervention

Arm Description

Intervention consisted of eight weekly sessions of health education and diabetes management. Topics covered include recognition of diabetes and its complications, risk factors, nutrition knowledge, dietary practices, exercise, behavioral self-monitoring, medication adherence, and stress management. Intervention also included a home visit for training of monitoring devices use, WeChat app and acquiring family support, and weekly 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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. .

Full Information

First Posted
January 28, 2021
Last Updated
February 2, 2021
Sponsor
Claremont Graduate University
Collaborators
AHMC Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04737499
Brief Title
Culturally Appropriate Strategies for Chinese Americans With Diabetes (CASCADe)
Official Title
Implementation and Evaluation of A Culturally Tailored Diabetes Self-Management Program for Chinese Americans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 5, 2016 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
March 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Claremont Graduate University
Collaborators
AHMC Health Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Chinese Americans, Type 2 Diabetes, mHealth, Diabetes Self-Management and Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group pre- and post-test design
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CASCADe Intervention
Arm Type
Experimental
Arm Description
Intervention consisted of eight weekly sessions of health education and diabetes management. Topics covered include recognition of diabetes and its complications, risk factors, nutrition knowledge, dietary practices, exercise, behavioral self-monitoring, medication adherence, and stress management. Intervention also included a home visit for training of monitoring devices use, WeChat app and acquiring family support, and weekly 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.
Intervention Type
Behavioral
Intervention Name(s)
CASCADe
Intervention Description
Culturally tailored diabetes self-management and education sessions with mHealth integration
Primary Outcome Measure Information:
Title
Change of Concentration of HbA1c
Description
HbA1c was assessed using the testing kit of A1C Now+ with a finger prick of blood by trained data collector.
Time Frame
Change from baseline HbA1c at 3 months
Secondary Outcome Measure Information:
Title
Change of Score of Self-efficacy
Description
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.
Time Frame
Change from baseline Self-efficacy score at 3 months
Title
Change of Score of Quality of life
Description
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. .
Time Frame
Change from baseline Quality of life score at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Clarement Graduate University
City
Claremont
State/Province
California
ZIP/Postal Code
91711
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified datasets with individual participant data will be provided by the Principal Investigator upon request. All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the research investigating team.

Learn more about this trial

Culturally Appropriate Strategies for Chinese Americans With Diabetes (CASCADe)

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