Technology to Improve the Health of Resource-poor Hispanics With Diabetes
NCT ID: NCT03394456
Last Updated: 2022-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
265 participants
INTERVENTIONAL
2018-01-13
2022-08-30
Brief Summary
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Detailed Description
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The primary study (n=89; Cohorts 1,2) compares clinical outcomes and treatment satisfaction of individuals who receive diabetes care in a 12-month telehealth supported, integrated CHW-led group visit program compared to those in usual care (wait list control). Group visits are 6-months and CHWs contact patients weekly to bimonthly (mobile health (mHealth)) for 12-months. This phase with have two cohort waves, separated by 6-months. The wait list control group for Cohort 2 will explore telehealth, clinician-patient encounters. A secondary study (n=59; Cohorts 3,4) at a new clinic evaluates the ability to implement the program. In the first phase of the secondary study the research team will conduct a RCT of individuals randomized to the diabetes program (intervention) vs usual care (control) to assess clinic feasibility. The clinic team will observe this process and learn the project protocols during Phase 1. In the second phase, the clinic team will lead the group visits while the research team mentors them to conduct the project in-person at the group visits and via telehealth each week (ZOOM video conferencing). Another secondary study (n=138; Cohort 5) aims to expand the reach of the education and CHW intervention for individuals who may not be able to or cannot come to the clinic for group visits. Specifically, individuals will received the education from the program monthly via a secure text message video, CHWs will contact weekly to bimonthly to advocate for their needs, and participants will receive their routine care as usual in the clinic.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Receive diabetes group visits/diabetes program
diabetes program
Comprehensive diabetes program (weekly to bimonthly CHW mHealth contact (phone, text) for 12-months and monthly diabetes group visits for 6-months)
telehealth training and support for Community Health Workers
weekly 1-hour diabetes training and patient support for CHWs via telehealth i.e., ZOOM technology for the study duration
Control
Receive usual care in the clinic, followed by group visits (wait list control) for cohorts 1-4 case-matched comparisons via chart review for cohort 5
No interventions assigned to this group
Interventions
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diabetes program
Comprehensive diabetes program (weekly to bimonthly CHW mHealth contact (phone, text) for 12-months and monthly diabetes group visits for 6-months)
telehealth training and support for Community Health Workers
weekly 1-hour diabetes training and patient support for CHWs via telehealth i.e., ZOOM technology for the study duration
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Baylor College of Medicine
OTHER
Responsible Party
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Elizabeth Vaughan
Principal Investigator
Principal Investigators
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Elizabeth Vaughan, DO
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.
Dias S, Gama A. [Community-based participatory research in public health: potentials and challenges]. Rev Panam Salud Publica. 2014 Feb;35(2):150-4. Portuguese.
Mbuagbaw L, Thabane L, Ongolo-Zogo P, Lang T. The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial. Trials. 2011 Jun 9;12:145. doi: 10.1186/1745-6215-12-145.
Furino A. Community Health Worker National Workforce Study. Wasthington, DC: US Dept of Health and Human Services; 2007.
Norris SL, Chowdhury FM, Van Le K, Horsley T, Brownstein JN, Zhang X, Jack L Jr, Satterfield DW. Effectiveness of community health workers in the care of persons with diabetes. Diabet Med. 2006 May;23(5):544-56. doi: 10.1111/j.1464-5491.2006.01845.x.
Lujan J, Ostwald SK, Ortiz M. Promotora diabetes intervention for Mexican Americans. Diabetes Educ. 2007 Jul-Aug;33(4):660-70. doi: 10.1177/0145721707304080.
Vaughan EM, Virani S, Al Rifai M, Cardenas VJ Jr, Johnston CA, Porterfield L, Santiago Delgado Z, Samson SL, Schick V, Naik AD. Determining call-to-entry rate and recruitment barriers in clinical studies for community clinics serving low-income populations: a cohort study. BMJ Open. 2023 Oct 28;13(10):e077819. doi: 10.1136/bmjopen-2023-077819.
Vaughan EM, Cardenas VJ Jr, Chan W, Amspoker AB, Johnston CA, Virani SS, Ballantyne CM, Naik AD. Implementation and Evaluation of a mHealth-Based Community Health Worker Feedback Loop for Hispanics with and at Risk for Diabetes. J Gen Intern Med. 2024 Feb;39(2):229-238. doi: 10.1007/s11606-023-08434-7. Epub 2023 Oct 6.
Vaughan EM, Hyman DJ, Naik AD, Samson SL, Razjouyan J, Foreyt JP. A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial. J Gen Intern Med. 2021 Feb;36(2):455-463. doi: 10.1007/s11606-020-06017-4. Epub 2020 Jul 22.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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H-40322
Identifier Type: OTHER
Identifier Source: secondary_id
H-40322
Identifier Type: -
Identifier Source: org_study_id
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