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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • CHW-enabled CCL

    Behavioral

    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) videos

    Behavioral

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

Treatment groups

480 Participants
are divided into 3 treatment groups
Group A: Patients in a CHW-enabled clinic that receive mobile health (mHealth) videosExperimental treatment 2 interventions
Group B: Patients in a CHW-enabled clinic that do not receive mHealth videosExperimental treatment 1 intervention
Group C: Patients in a standard clinic that do not receive mHealth videosNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in HbA1c levels

Time frame
Baseline, Month 6

Secondary outcomes

1

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
2

Percentage of patients accepting Community Health Worker (CHW) support

Time frame
Month 12
3

Percentage of patients accepting mHealth

Time frame
Month 12
4

Percent completion of social service referrals

Time frame
Month 6

Other outcomes

Sponsors and contacts

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