Type2 Diabetes Mellitus
Conditions
Keywords
T2DM, Diabetes
Brief summary
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
BEHAVIORALCHW-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.
BEHAVIORALMobile health (mHealth) diabetes self-management education and support (DSMES) videos
Participants will receive 24 culturally tailored DSMES videos through text message.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels | Baseline, Month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of satisfaction with community-clinic linkage (CCL) and mHealth | Month 12 | Participants are asked to rate satisfaction on a scale of 1 (not satisfied at all) to 10 (very satisfied). |
| Percentage of patients accepting Community Health Worker (CHW) support | Month 12 | — |
| Percentage of patients accepting mHealth | Month 12 | — |
| Percent completion of social service referrals | Month 6 | — |
| Percent mhealth videos watched | Month 12 | — |
Countries
United States
Contacts
Primary ContactBrita Roy
Backup ContactJulia Duch
Outcome results
None listed