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

NYU Langone Health

Status: Not yet enrolling

Conditions: Type2 Diabetes Mellitus

Treatments: Behavioral: CHW-enabled CCL; Behavioral: Mobile health (mHealth) diabetes self-management education and support (DSMES) videos

Study type: Interventional

Funder types: Other

Identifiers

NCT07296211

5U48DP006778 (U.S. NIH Grant/Contract)

24-01080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 3 patient groups

Patients in a CHW-enabled clinic that receive mobile health (mHealth) videos

Experimental group

Description:

For the first 6 months participants will receive CHW-enabled services from their clinic. Over the next 6 months participants will receive 24 culturally tailored diabetes education videos via text message.

Treatment:

Behavioral: Mobile health (mHealth) diabetes self-management education and support (DSMES) videos

Behavioral: CHW-enabled CCL

Patients in a CHW-enabled clinic that do not receive mHealth videos

Experimental group

Description:

For the first 6 months participants will receive CHW-enabled services from their clinic. Over the next 6 months participants will continue to receive standard of care (SOC).

Treatment:

Behavioral: CHW-enabled CCL

Patients in a standard clinic that do not receive mHealth videos

No Intervention group

Description:

For 12 months participants will be followed as they receive SOC from their clinic.