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| ID | Type | Description | Link |
|---|---|---|---|
| 5U48DP006778 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in a CHW-enabled clinic that receive mobile health (mHealth) videos | Experimental | 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. |
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| Patients in a CHW-enabled clinic that do not receive mHealth videos | Experimental | 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). |
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| Patients in a standard clinic that do not receive mHealth videos | No Intervention | For 12 months participants will be followed as they receive SOC from their clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c levels | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Month 12 |
| Percentage of patients accepting Community Health Worker (CHW) support |
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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
1. Willing to receive text messages with brief videos regarding T2DM management
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brita Roy | Contact | 347-377-3157 | Brita.Roy@nyulangone.org | |
| Julia Duch | Contact | 201-424-3571 | Julia.Duch@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Nadia Islam, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Brita.Roy@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Brita.Roy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| Mobile health (mHealth) diabetes self-management education and support (DSMES) videos | Behavioral | Participants will receive 24 culturally tailored DSMES videos through text message. |
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| Month 12 |
| Percentage of patients accepting mHealth | Month 12 |
| Percent completion of social service referrals | Month 6 |
| Percent mhealth videos watched | Month 12 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D010166 | Palliative Care |
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |
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