Menu
Not yet recruiting NCT07296211

INcreasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income VulneRablE Immigrants

No phase Interventional Type2 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CHW-enabled CCL, Mobile health (mHealth) diabetes self-management education and support (DSMES) videos.
Who it may be relevant to
Registry conditions: Type2 Diabetes Mellitus. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Increasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income Vulnerable Immigrants

Overview

The purpose of this study is to evaluate a multi-level approach to improve diabetes control via access to social service supports and online, culturally-tailored diabetes self-management education and support (DSMES) videos among a community of primarily Chinese and Latino/a immigrants. The study aims to assess patient uptake, provider adoption, and INSPIRE program acceptability, appropriateness, feasibility, fidelity, penetration/reach, and maintenance.

Detailed description

In stage 1, the 8 family health center (FHC) clinics will be randomized 1:1 into Experimental Cohort A, which will receive the Community Health Worker (CHW)-enabled community-clinic linkage model (CCL) or Control Cohort B, with FHCs that will not receive the CHW-enabled CCL. Then, in stage 2, patients in clinics that received the CHW-enabled CCL will be randomized in a 1:1 ratio to Arm A who will receive text-based mhealth diabetes education videos or Arm B who will not receive mhealth.

Interventions

  • Behavioral CHW-enabled CCL
    The FHCs has access to the CHW-enabled CCL. With this intervention, participants will be screened for social determinants of health (SDoH) and be referred to care and social services that address any identified needs.
  • Behavioral Mobile health (mHealth) diabetes self-management education and support (DSMES) videos
    Participants will receive 24 culturally tailored DSMES videos through text message.

Primary outcome measures

  • Change in HbA1c levels [Time frame: Baseline, Month 6]
Secondary outcome measures (5)
  • Level of satisfaction with community-clinic linkage (CCL) and mHealth [Time frame: Month 12]
  • Percentage of patients accepting Community Health Worker (CHW) support [Time frame: Month 12]
  • Percentage of patients accepting mHealth [Time frame: Month 12]
  • Percent completion of social service referrals [Time frame: Month 6]
  • Percent mhealth videos watched [Time frame: Month 12]

Eligibility criteria

Inclusion criteria

To be eligible to participate in this study, the patient participant must meet all the following criteria:

  • ≥18 years old and ≤ 70 years old
  • Self-identify their primary language as English, Mandarin, Cantonese, or Spanish
  • Diagnosed with T2DM
  • Has their most recent HbA1c ≥8% or have a new diagnosis of T2DM within the past 6 months

For patient participants randomized to the mHealth cohort, they must meet the below inclusion criteria

1\. Willing to receive text messages with brief videos regarding T2DM management

Exclusion criteria

  • Unable or unwilling to provide informed consent
  • Unable to participate meaningfully in the intervention (e.g. uncorrected sight and hearing impairment)
  • Is currently pregnant (Pregnant women will be excluded from this study because they may have special dietary restrictions that are not covered by our DSMES videos for the general population with T2DM.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07296211 · 24-01080 · 5U48DP006778

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗