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Family Intervention for Chinese Americans With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wait-list control group
SMS intervention
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes focused on measuring Chinese Americans

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Wait-list Control

SMS Intervention

Arm Description

Standard of care

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.

Outcomes

Primary Outcome Measures

Percentage of Videos Watched by Participants
Measure of SMS intervention feasibility.
Satisfaction Questionnaire Score
10-item assessment of acceptability of SMS intervention. Higher scores indicate greater acceptability/satisfaction.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 26, 2019
Last Updated
October 26, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04108299
Brief Title
Family Intervention for Chinese Americans With Type 2 Diabetes
Official Title
Feasibility of a Family-oriented mHealth Intervention for Chinese Americans With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

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 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.
Detailed 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.

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait-list Control
Arm Type
Placebo Comparator
Arm Description
Standard of care
Arm Title
SMS Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wait-list control group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMS intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Videos Watched by Participants
Description
Measure of SMS intervention feasibility.
Time Frame
Up to Month 6
Title
Satisfaction Questionnaire Score
Description
10-item assessment of acceptability of SMS intervention. Higher scores indicate greater acceptability/satisfaction.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Change in HbA1c Level
Description
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.
Time Frame
Baseline, Month 6
Title
Change in Diabetes Management Self-Efficacy Scale (DMSES) Score
Description
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.
Time Frame
Baseline, Month 6
Title
Change in Summary of Diabetes Self-Care Activities (SDSCA) Score
Description
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.
Time Frame
Baseline, Month 6
Title
Change in Michigan Diabetes Knowledge Test Score
Description
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.
Time Frame
Baseline, Month 6
Title
Change in Mediterranean Dietary Screener (MEDAS) Score
Description
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.
Time Frame
Baseline, Month 6
Title
Change in International Physical Activity Questionnaire (IPAQ)-short version Score
Description
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.
Time Frame
Baseline, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu Hu, PhD
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Requests should be directed to lu.hu@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Family Intervention for Chinese Americans With Type 2 Diabetes

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