Implementing an Effective Diabetes Intervention Among Low-Income Immigrants
IDEAL
IDEAL: Implementing an Effective Diabetes intervEntion Among Low-income Immigrants
1 other identifier
interventional
270
1 country
1
Brief Summary
The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic control among Chinese immigrants with Type 2 diabetes (T2D) in New York City (NYC). Participants will be randomized with equal allocation to one of the 2 groups. The IDEAL group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The CHW will assess participants' SDOH barriers to T2D care and link them to available resources in the community. The CONTROL group will continue to receive their usual care and at the end of the study, they will receive DSMES videos.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Dec 2024
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedStudy Start
First participant enrolled
December 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
March 9, 2026
March 1, 2026
3 years
March 13, 2024
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Hemoglobin A1C (HbA1c) Test Scores
Scores expressed as a percentage of red blood cells that have sugar-coated hemoglobin. Patients with Type 2 Diabetes receive a HbA1c blood test at their doctors' office every 3-6 months as part of usual care; testing results will be abstracted from the medical record at the participant's health care facility to minimize participant burden.
Baseline, Month 6
Change in Hemoglobin A1C (HbA1c) Test Scores
Scores expressed as a percentage of red blood cells that have sugar-coated hemoglobin. Patients with Type 2 Diabetes receive a HbA1c blood test at their doctors' office every 3-6 months as part of usual care; testing results will be abstracted from the medical record at the participant's health care facility to minimize participant burden.
Baseline, Month 12
Secondary Outcomes (15)
Stanford Self-Efficacy for Diabetes Scale Score
Baseline
Stanford Self-Efficacy for Diabetes Scale Score
Month 6
Stanford Self-Efficacy for Diabetes Scale Score
Month 12
Summary of Diabetes Self-Care Activities (SDSCA) Score
Baseline
Summary of Diabetes Self-Care Activities (SDSCA) Score
Month 6
- +10 more secondary outcomes
Study Arms (2)
DSMES+CHW (IDEAL)
EXPERIMENTALParticipants in this group will receive brief pre-recorded DSMES videos, which include both educational and Social Cognitive Theory-based behavioral content. Participants will receive 1 DSMES video via text message each week for a total of 24 weeks with each video lasting about 5 minutes in duration. In addition, they will also receive brief phone calls from CHWs every 2 weeks during the 24 weeks video program. During these calls, CHWs will assess whether participants need assistance on social determinants of health (SDOH) barriers. If needed, CHWs will link participants to available services within the community. CHWs will also provide assistance on navigating the complex health care systems and serve as an advocate for patients during doctor visits if needed.
Wait-list control group (CONTROL)
NO INTERVENTIONParticipants in this group will continue to receive the standard of usual care for their T2D at their doctor's office during the course of our study.
Interventions
Text message-delivered video-based DSMES intervention.
Assess participants' SDOH barriers to Type 2 diabetes care and link them to available resources in the community.
Eligibility Criteria
You may qualify if:
- Participants must:
- self-identify as a Chinese immigrant;
- be between 18-70 years old,
- have a diagnosis of T2D in the medical record;
- have had an appointment with a physician for routine T2D care within the past 12 months;
- have a most recent HbA1c \> or = 8%;
- be willing to receive brief videos regarding T2D management, and
- possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.
You may not qualify if:
- 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;
- is pregnant, plans to become pregnant in the next 6 months, or becomes pregnant during the study, or
- is breastfeeding (e.g., they may have potential dietary restrictions).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lu Hu, PhD
NYU School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2024
First Posted
March 20, 2024
Study Start
December 29, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Lu.hu@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Lu.hu@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.