- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394456
Technology to Improve the Health of Resource-poor Hispanics With Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The number of Hispanics diagnosed with diabetes is escalating in the US with disproportionately higher prevalence and complication rates than other ethnicities. CHWs are a well-established and culturally sensitive means to bridge gaps in care to individuals with diabetes. However CHWs are often left unsupported, placing patients at risk of substandard care or harm. Telehealth is a term used to describe a range of technologies to support healthcare delivery via communication with the patient or a member of the healthcare delivery team. Though telehealth has been implemented into diabetes programs for many years, there is a paucity of data showing the use of telemedicine for CHW training and support.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hispanic adults with diabetes, low-income (earn less than/equal to 250% federal poverty level)
Exclusion Criteria:
- not able to understand Spanish, group visit is not appropriate for care i.e., need individualized care, pregnancy, etc
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Receive diabetes group visits/diabetes program
|
Comprehensive diabetes program (weekly to bimonthly CHW mHealth contact (phone, text) for 12-months and monthly diabetes group visits for 6-months)
weekly 1-hour diabetes training and patient support for CHWs via telehealth i.e., ZOOM technology for the study duration
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No Intervention: 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic control
Time Frame: At baseline and every 6-months until study completion
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Hemoglobin A1c (%)
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At baseline and every 6-months until study completion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to preventive care guidelines
Time Frame: pre/post diabetes group visits
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As measured by placement on a statin, annual urine micro albumin, target A1c, weight loss (if applicable), retinal eye examination, blood pressure targets, serum B12 measurements, vaccinations.
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pre/post diabetes group visits
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Survey
Time Frame: at the beginning and end of each cohort (baseline, six-months)
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The survey totaled 12 questions and assessed participant satisfaction, mental relaxation, faith/spirituality, and open-ended comments.
Questions were ranked as followed: 1-3 (4-point Likert Scale), 4-7 (10-point Likert Scale), 8-11 (open-ended, descriptive), 12 (days of exercise/week).
The Use of Mental Stress Management/Relaxation Techniques questionnaire and our pilot study survey templates were used to evaluate patient group visit and CHW satisfaction.
We defined acceptability as high (3.5-4/4 or 8-10/10), moderate (2-3.4/4 or 4-7/10), and low (1-1.9/4
or 1-3/10) and totaled the items to create an overall score.
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at the beginning and end of each cohort (baseline, six-months)
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Diabetes-related health
Time Frame: at the beginning and end of each cohort (baseline, six-months)
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As measured by the Self Management Resource Center Surveys: Diabetes Medications (a 4-question yes/no survey to assess patient medication adherence and understanding of their medications), Self-rated Health (a 1-question ranked on a 5-point scale (1 is excellent, 5 is poor) to determine the patient's view of their health)
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at the beginning and end of each cohort (baseline, six-months)
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Body Mass Index (BMI)
Time Frame: At baseline and every 6-month until study completion
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Body Mass Index (BMI) (weight in kg/height in m^2)
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At baseline and every 6-month until study completion
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Blood Pressure
Time Frame: At baseline and every 6-month until study completion
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Blood Pressure (mmHg)
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At baseline and every 6-month until study completion
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Barriers to care
Time Frame: weekly to bimonthly from baseline to 12-months
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We obtain barriers to care data from the CHW-patient mobile health (mHealth) records and chart review, and group into three categories: obtaining medications, appointment access, clinic eligibility.
mHealth records were sent to the study physician through a secure, encrypted site on a weekly basis.
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weekly to bimonthly from baseline to 12-months
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longitudinal outcomes
Time Frame: from the time group visits end and as long as month-24 after
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conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including blood pressure (mmHg)
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from the time group visits end and as long as month-24 after
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longitudinal outcomes
Time Frame: from the time group visits end and as long as month-24 after
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conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including HbA1c (%)
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from the time group visits end and as long as month-24 after
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longitudinal outcomes
Time Frame: from the time group visits end and as long as month-24 after
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conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including BMI (kg/m^2)
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from the time group visits end and as long as month-24 after
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and acceptability of telehealth patient, clinician encounters during diabetes group visits
Time Frame: At six months after group visits for wait list control Cohort 2
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As measured by the Telehealth Usability Questionnaire(21-question survey where 1 is strongly disagree and 5 is strongly agree)
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At six months after group visits for wait list control Cohort 2
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Feasibility and acceptability of telehealth support for community health workers 2
Time Frame: At baseline and six months during Cohort 1 intervention group
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The Diabetes Knowledge Test (University of Michigan, 2015; 23 questions; where a total score of 0 indicates the least and 23 indicates the most diabetes knowledge based on this test)
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At baseline and six months during Cohort 1 intervention group
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Feasibility and acceptability of telemedicine support for community health workers
Time Frame: After each cohort (every six months)
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As measured by a six-month 4-question survey (four open-ended questions i.e., what CHWs liked, disliked, general comments) and a 10-question multiple choice posttest that covers content they were taught the last six months (Vaughan et al, 2018)
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After each cohort (every six months)
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Feasibility and acceptability of telemedicine support for community health workers
Time Frame: After Cohort 1
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As measured by the Telehealth Usability Questionnaire(21-question survey where 1 is strongly disagree and 5 is strongly agree)
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After Cohort 1
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CHW knowledge
Time Frame: During Cohort 2 at baseline (TEST-1 pretest), 6- (TEST-1 posttest, TEST-2 pretest) and 12-months (TEST-2 posttest)
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As measured by pre- /post-tests.
TEST-1 (n=21 questions) and TEST-2 (n=19 questions).
Tests were multiple choice with 3-5 answer option and were original to this study.
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During Cohort 2 at baseline (TEST-1 pretest), 6- (TEST-1 posttest, TEST-2 pretest) and 12-months (TEST-2 posttest)
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CHW knowledge
Time Frame: During the secondary study, at baseline and 6-months (pre/posttest)
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This will be accomplished by the 24-question Starr County Diabetes Knowledge Test, which has shown validity and reliability in English and Spanish.
Each of the 24-question has three answer choices.
This will be pre/posttest format.
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During the secondary study, at baseline and 6-months (pre/posttest)
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Access to care
Time Frame: from baseline to 12-months
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As measured by the amount of contact participants had with the clinic during the intervention
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from baseline to 12-months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth Vaughan, DO, Baylor College of Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-40322 (Other Identifier: Baylor College of Medicine IRB)
- K23DK110341 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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