- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04737499
Culturally Appropriate Strategies for Chinese Americans With Diabetes (CASCADe)
February 2, 2021 updated by: Claremont Graduate University
Implementation and Evaluation of A Culturally Tailored Diabetes Self-Management Program for Chinese Americans
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Claremont, California, United States, 91711
- Clarement Graduate University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CASCADe Intervention
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.
|
Culturally tailored diabetes self-management and education sessions with mHealth integration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Concentration of HbA1c
Time Frame: Change from baseline HbA1c at 3 months
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HbA1c was assessed using the testing kit of A1C Now+ with a finger prick of blood by trained data collector.
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Change from baseline HbA1c at 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Score of Self-efficacy
Time Frame: Change from baseline Self-efficacy score at 3 months
|
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.
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Change from baseline Self-efficacy score at 3 months
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Change of Score of Quality of life
Time Frame: Change from baseline Quality of life score at 3 months
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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. .
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Change from baseline Quality of life score at 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2016
Primary Completion (Actual)
February 15, 2018
Study Completion (Actual)
March 20, 2018
Study Registration Dates
First Submitted
January 28, 2021
First Submitted That Met QC Criteria
February 2, 2021
First Posted (Actual)
February 4, 2021
Study Record Updates
Last Update Posted (Actual)
February 4, 2021
Last Update Submitted That Met QC Criteria
February 2, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGU IRB#2522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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