Family Intervention for Chinese Americans With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Feasibility of a Family-oriented mHealth Intervention for Chinese Americans With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108299
• Other study ID #: 19-01275
• Status: Completed
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: October 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot study is to examine the feasibility and acceptability of a family-oriented SMS intervention in 30 Chinese Americans with T2D and their family members. Participants will be randomized to one of 2 arms (n=15 each): 1) wait-list control and 2) SMS intervention. Both groups will continue to receive standard of care treatment for their T2D. The SMS group will receive brief lifestyle counseling videos via SMS links. At the end of the study, the wait-list control group will be provided the opportunity to receive the counseling videos.

Description:

Chinese Americans are one of the fastest growing immigrant groups in the US, who suffer disproportionately high type 2 diabetes (T2D) burden and have poorly controlled T2D. Given the high economic and societal burden of T2D and rapid population growth in Chinese Americans, there is an urgent need for research to develop effective interventions to address T2D burden in this population. Recent evidence suggests the importance of involving and empowering family members in diabetes intervention and calls for family intervention. A mobile health approach such as short message service (SMS) might be a promising way to deliver such family-oriented interventions to the target population given prior studies suggests that Chinese Americans often report challenges to attend in-person lifestyle counseling because of long working hours and lack of sick time from work. A SMS-based intervention provides the flexibility of allowing them to view the intervention at a time and place convenient to them. This study will serve as the first step to explore an alternative approach for managing T2D in this group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Inclusion criteria for patient participants:

• self-identify as Chinese or Chinese American;

• be between the ages of 18 and 70,

• self-report a diagnosis of T2D;

• be willing to receive WeChat messages regarding T2D management,

• possess a smartphone or be willing and able to use a study smartphone. If participants have their own smartphones, they are encouraged to use their own phones. For participants who do not have smartphones, the study will provide them

• has a family member or friend be willing to participate in the study to learn about T2D to better support them

Inclusion criteria for family/friend participants: family/friend participants must

• be between 18-70 years old,

• be willing to receive WeChat messages regarding T2D management

• possess a smartphone or be willing and able to use a study smartphone. If participants have their own smartphones, they are encouraged to use their own phones. For participants who do not have smartphones, the study will provide them

Exclusion Criteria:

Exclusion criteria for both patient and family/friend participants:

• unable or unwilling to provide informed consent;

• unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);

• unwilling to accept randomization assignment;

• pregnant, plans to becomes pregnant in the next 6 months, or who become pregnant during the study, or

• breastfeeding.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Wait-list control group
For patient participants, they will continue to receive the standard of usual care for their T2D at the CBWCHC during the course of our study. For family/friend participants, they will continue to receive their routine care with their own doctors during the study. At the end of the study, the wait-list control group (both patient and family/friend participants) will be provided the opportunity to receive the counseling videos delivered to them via SMS links.
• SMS intervention
2-3 SMS-based diabetes videos will be sent to patients each week for 12 weeks (each video within 10 minutes in duration) to both patients and their family members. Patients and their family members will receive the same intervention videos, including basic information about T2D, importance of diabetes self-management at home, behavioral techniques, and family-oriented sessions. BrainShark will be used to determine whether participants view these,videos. For participants who miss 3 consecutive videos, the study team will follow-up with a phone call to identify barriers to watching the video and remind them to review the video.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Videos Watched by Participants	Measure of SMS intervention feasibility.	Up to Month 6
Primary	Satisfaction Questionnaire Score	10-item assessment of acceptability of SMS intervention. Higher scores indicate greater acceptability/satisfaction.	Month 6
Secondary	Change in HbA1c Level	Participants receive HbA1c blood test at their doctors' office every 3-6 months; HbA1c testing results will be abstracted from the medical record at the participant's health care facility.	Baseline, Month 6
Secondary	Change in Diabetes Management Self-Efficacy Scale (DMSES) Score	The DMSES is an 8-item assessment asking participants to rate their confidence level in performing diabetes-specific self-management behaviors, using a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). The total score is the sum of responses and ranges from 8 to 80; higher scores indicate greater self-efficacy. An increase in scores indicates self-efficacy improved during the observational period.	Baseline, Month 6
Secondary	Change in Summary of Diabetes Self-Care Activities (SDSCA) Score	The SDSCA is a 13-item assessment of participants' adherence to diabetes self-management behaviors. This scale consists of 13 items and asks participate to describe their diabetes self-care activities over the past 7 days. The total score is the sum of responses and ranges from 0 to 91; higher scores indicate greater adherence to self-management behaviors. An increase in scores indicates adherence improved during the observational period.	Baseline, Month 6
Secondary	Change in Michigan Diabetes Knowledge Test Score	The Michigan Diabetes Knowledge Test is a 23-item assessment of general knowledge of diabetes. Scores range from 0 (minimum) to 100 (maximum), with higher scores indicating greater knowledge of diabetes. An increase in scores indicates knowledge increased during the observational period.	Baseline, Month 6
Secondary	Change in Mediterranean Dietary Screener (MEDAS) Score	The MEDAS is a 14-item assessment of participants' adherence to the Mediterranean diet. Total scores are classified as low (0-7 points), moderate (8-10 points) and high (11-17 points). An increase in scores indicates adherence increased during the observational period.	Baseline, Month 6
Secondary	Change in International Physical Activity Questionnaire (IPAQ)-short version Score	The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. Higher scores indicate higher levels of physical activity. An increase in scores indicates physical activity increased during the observational period.	Baseline, Month 6