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

N/ANot Yet RecruitingNCT07296211

NYU Langone Health480 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

480

Conditions

Type2 Diabetes Mellitus

Interventions

CHW-enabled CCLBEHAVIORAL

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.

Mobile health (mHealth) diabetes self-management education and support (DSMES) videosBEHAVIORAL

Participants will receive 24 culturally tailored DSMES videos through text message.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: To be eligible to participate in this study, the patient participant must meet all the following criteria: 1. ≥18 years old and ≤ 70 years old 2. Self-identify their primary language as English, Mandarin, Cantonese, or Spanish 3. Diagnosed with T2DM 4. 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: 1. Unable or unwilling to provide informed consent 2. Unable to participate meaningfully in the intervention (e.g. uncorrected sight and hearing impairment) 3. 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.)

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Change in HbA1c levels

Time frame: Baseline, Month 6

Secondary Outcomes

Level of satisfaction with community-clinic linkage (CCL) and mHealth

Participants are asked to rate satisfaction on a scale of 1 (not satisfied at all) to 10 (very satisfied).

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

Central Contacts

Brita Roy

CONTACT

347-377-3157 Brita.Roy@nyulangone.org

Julia Duch

CONTACT

201-424-3571 Julia.Duch@nyulangone.org

Data from ClinicalTrials.gov

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