NYU Langone Health
New York, 10016, United States
NCT Number: NCT07296211
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
New York, 10016, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To be eligible to participate in this study, the patient participant must meet all the following criteria:
For patient participants randomized to the mHealth cohort, they must meet the below inclusion criteria
Exclusion criteria
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.
Participants will receive 24 culturally tailored DSMES videos through text message.
Time frame: Baseline, Month 6
Time frame: Month 12
Participants are asked to rate satisfaction on a scale of 1 (not satisfied at all) to 10 (very satisfied).
Time frame: Month 12
Time frame: Month 12
Time frame: Month 6
Time frame: Month 12
Contact information is provided by the study sponsor or research team.
NYU Langone Health
Other
Acronym: INSPIRE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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