Diabetes Mellitus, Type 2NCT04835493
Evaluating Telementoring for CHW-centered Diabetes Initiatives
A study testing Intervention in people with Diabetes Mellitus, Type 2, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Diabetes care is complex and requires a multidimensional approach, but interventional programs are difficult to initiate in low-income and minority populations. In the proposed study, investigators will mentor local clinics via telehealth to initiate our diabetes program involving telehealth-support, integrated CHWs… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identified Latino(a)
- Spanish-speaking
- >/=18 years
- type 2 diabetes (T2D), e.g., HbA1c >/=6.5%, provider documented T2D, on oral anti-hyperglycemic
- uninsured, <150% federal poverty level
Who cannot join
- no show to all group visits
- condition that may alter HbA1c levels, e.g., recent blood transfusion
- patients at high-risk or not appropriate for care in a group setting e.g., pregnancy, severe cognitive impairment, frequent clinic appointments for labile glucose/medication titration e.g., insulin.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Houston, Texas, 77030
About this study
Official title: Evaluating Telementoring to Initiate a Multidimensional Diabetes Program for Latino(a)s in Community Clinics: A Randomized Clinical Trial
Diabetes care is complex and requires a multidimensional approach, but interventional programs are difficult to initiate in low-income and minority populations. In the proposed study, investigators will mentor local clinics via telehealth to initiate our diabetes program involving telehealth-support, integrated CHWs, medication-access, and diabetes Education into their clinics. Mentoring local clinics to initiate this intervention is a promising strategy to enhance sustainable diabetes care and reduce disparities in vulnerable minority populations.
Read the detailed description
Diabetes is a major public health problem in Latino(a)s. There are escalating numbers of Latino(a)s diagnosed with diabetes and at disproportionate rates compared to other ethnicities. Numerous interventions have been initiated to improve minority healthcare including diabetes group visits, which have been valuable in improving education and glycemic control. In our group visit investigations, investigators initiated Community Health Workers (CHWs)-local community members who serve as culturally-sensitive patient liaisons to the healthcare system-as part of the multidisciplinary team. Investigators demonstrated that CHWs are vital team members and particularly helpful in identifying medication-access barriers. However, CHWs are frontline workers and often left unsupported and poorly supervised. Investigators used these data to pioneer the combination of four diabetes interventions. This trial showed that individuals randomized to the intervention significantly improved glycemic control, blood pressure and adherence to American Diabetes Association standards compared to usual care. The study also showed that telehealth (mobile health (mHealth) and ZOOM video conferencing) was instrumental in supporting CHWs in their work and enhancing their communication with patients.
The COVID-19 pandemic has highlighted the expansive use of telehealth and its ability to improve healthcare. It has also underscored the pressing need to improve care for low-income minorities. Though diabetes programs are valuable in improving education and clinical outcomes, they are often difficult to initiate in low-income settings. Pragmatic implementation using telehealth to mentor local clinic teams of providers and CHWs is promising to address these barriers. Investigators have pilot data showing the feasibility of telementoring a local clinic to initiate our program that has resulted in improved HbA1c levels but it needs to be tested within a larger sample. In the proposed study investigators will evaluate this approach in a randomized clinical trial (N=320; intervention=160) of low-income, adult Latino(a)s with type 2 diabetes randomized to the diabetes program intervention versus usual care (UC). Our research group will provide telementoring to local clinic teams to initiate our program into their clinics. To evaluate efficacy, investigators will compare the intervention versus UC clinical changes including HbA1c (primary outcome), blood pressure, cholesterol, and body mass index from baseline to 12-months (AIM 1). To compare longitudinal data of study arms, investigators will follow these clinical measures until 36 months (AIM 2). Investigators will also provide program acceptability and evaluation data for participants and clinic teams from baseline to 12-months (AIM 3). Investigators hypothesize that intervention participants will have superior and more sustainable clinical outcomes compared to UC individuals and that the intervention will have high levels of acceptability and evaluation data. Investigators anticipate that the proposed study will provide justification of telementoring to initiate the intervention and strong evidence to improve the longitudinal care of low-income Latino(a)s with diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
In the proposed study, we will conduct a randomized clinical trial of low-income, adult Latino(a)s with type 2 diabetes randomized at the individual level a telehealth-supported, integrated CHWs, medication-access, diabetes education program) (intervention) versus usual care (UC). Our research team will provide telementoring to local clinic teams (providers and CHWs) to initiate the 12-month the program into their clinics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention individuals will receive the 12-month diabetes program Receives: Other: Intervention |
| Usual Care (UC) | Other | We will define UC as usual clinical care, which consists of diabetes management provider encounters (mean quarterly) plus monthly individual appointments with a pharm-Ds or nutritionists as clinically indicated. In addition, clinics offer multiple other individual and group opportunities. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (%)
Compare intervention versus control HbA1c levels (%)
Measured: Baseline to 12-months
Secondary outcomes (10)
Systolic Blood Pressure mmHg
Compare intervention versus control blood pressure levels (systolic) mmHg
Measured: Baseline to 12-months
Body Mass Index (BMI)
Compare intervention versus control BMI levels
Measured: Baseline to 12-months
Total Cholesterol
Compare intervention versus control total cholesterol levels
Measured: Baseline to 12-months
American Diabetes Association (ADA) Adherence Measures: Diabetes Foot Exam
Compare intervention versus control adherence to diabetes foot exams
Measured: Baseline to 12-months
ADA Adherence Measures: Diabetes Eye Exam Screening
Diabetes eye exam screening was assessed based on electronic medical record review (EMR) of whether participants had received an order for screening during the intervention.
Measured: Baseline to 12-months
ADA Adherence Measures: Urine Microalbumin Screening
Urine microalbumin screening was assessed based on electronic medical record review (EMR) of whether participants had completed a lab for urine microalbumin screening during the intervention.
Measured: Baseline to 12-months
ADA Adherence Measures: Flu Vaccination
Flu vaccination was assessed based on electronic medical record review (EMR) of whether participants had completed annual flu vaccinations during the intervention.
Measured: Baseline to 12-months
Average Score for CHW Support on Program Satisfaction Questionnaire
Program satisfaction was assessed using a 0-10 satisfaction scale, with 0 indicating the lowest level of satisfaction and 10 indicating the highest level of satisfaction.
Measured: 12-months
Attrition
Rate of attrition for participants
Measured: baseline to 12-months
Diastolic Blood Pressure mmHg
Compare intervention versus control blood pressure levels (diastolic) mmHg
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Sep 2022
- Primary completion30 Apr 2025
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, University of Houston, Baylor College of Medicine, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Vaughan, DO, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835493
- Sponsor's protocol ID
- 22-0224
- Other IDs
- R01DK129474
- Status last verified
- Aug 2026
- First submitted
- 5 Apr 2021
- Last updated
- 14 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The NIH policy on data sharing does not apply to this protocol: (1) it is not basic research and involves human subjects, (2) it is anticipated that the data can be readily replicated as the purpose of the study is to train local clinics to conduct the program, (3) more than $500K in direct costs annually are not requested for any year of the protocol.
Publications
Vaughan EM, Yu X, Amspoker AB, Naik AD, Balasubramanyam A, Johnston CA, Ballantyne CM, Virani SS, Brown HS, Mena K, Porterfield LR. Structured Telehealth Community Health Worker-Clinician Feedback and Diabetes Outcomes: A Randomized Clinical Trial. JAMA Intern Med. 2026 Aug 1;186(8):1012-1021. doi: 10.1001/jamainternmed.2026.1917.
PubMed 42258200Ameri M, Jabbar LA, Kim S, Raji M, Samson SL, Vaughan EM. Training clinicians to facilitate diabetes group visits. BMC Med Educ. 2025 Feb 25;25(1):309. doi: 10.1186/s12909-025-06876-7.
PubMed 40001087Porterfield L, Warren V, Schick V, Gulliot-Wright S, Temple JR, Vaughan EM. Addressing Training Gaps: A Competency-Based, Telehealth Training Initiative for Community Health Workers. Telemed Rep. 2023 Jun 16;4(1):126-134. doi: 10.1089/tmr.2023.0007. eCollection 2023.
PubMed 37351464
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Telementoring to Initiate a Multidimensional Diabetes Program for Latino(a)s in Community Clinics: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04835493
- Acronym / sponsor ID
- 22-0224
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, University of Houston, Baylor College of Medicine, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Posted 14 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes care is complex and requires a multidimensional approach, but interventional programs are difficult to initiate in low-income and minority populations. In the proposed study, investigators will mentor local clinics via telehealth to initiate our diabetes program involving telehealth-support, integrated CHWs, medication-access, and diabetes Education into their clinics. Mentoring local clinics to initiate this intervention is a promising strategy to enhance sustainable diabetes care and reduce disparities in vulnerable minority populations.
Detailed description
Diabetes is a major public health problem in Latino(a)s. There are escalating numbers of Latino(a)s diagnosed with diabetes and at disproportionate rates compared to other ethnicities. Numerous interventions have been initiated to improve minority healthcare including diabetes group visits, which have been valuable in improving education and glycemic control. In our group visit investigations, investigators initiated Community Health Workers (CHWs)-local community members who serve as culturally-sensitive patient liaisons to the healthcare system-as part of the multidisciplinary team. Investigators demonstrated that CHWs are vital team members and particularly helpful in identifying medication-access barriers. However, CHWs are frontline workers and often left unsupported and poorly supervised. Investigators used these data to pioneer the combination of four diabetes interventions. This trial showed that individuals randomized to the intervention significantly improved glycemic control, blood pressure and adherence to American Diabetes Association standards compared to usual care. The study also showed that telehealth (mobile health (mHealth) and ZOOM video conferencing) was instrumental in supporting CHWs in their work and enhancing their communication with patients.
The COVID-19 pandemic has highlighted the expansive use of telehealth and its ability to improve healthcare. It has also underscored the pressing need to improve care for low-income minorities. Though diabetes programs are valuable in improving education and clinical outcomes, they are often difficult to initiate in low-income settings. Pragmatic implementation using telehealth to mentor local clinic teams of providers and CHWs is promising to address these barriers. Investigators have pilot data showing the feasibility of telementoring a local clinic to initiate our program that has resulted in improved HbA1c levels but it needs to be tested within a larger sample. In the proposed study investigators will evaluate this approach in a randomized clinical trial (N=320; intervention=160) of low-income, adult Latino(a)s with type 2 diabetes randomized to the diabetes program intervention versus usual care (UC). Our research group will provide telementoring to local clinic teams to initiate our program into their clinics. To evaluate efficacy, investigators will compare the intervention versus UC clinical changes including HbA1c (primary outcome), blood pressure, cholesterol, and body mass index from baseline to 12-months (AIM 1). To compare longitudinal data of study arms, investigators will follow these clinical measures until 36 months (AIM 2). Investigators will also provide program acceptability and evaluation data for participants and clinic teams from baseline to 12-months (AIM 3). Investigators hypothesize that intervention participants will have superior and more sustainable clinical outcomes compared to UC individuals and that the intervention will have high levels of acceptability and evaluation data. Investigators anticipate that the proposed study will provide justification of telementoring to initiate the intervention and strong evidence to improve the longitudinal care of low-income Latino(a)s with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: InterventionIntervention individuals will receive the 12-month diabetes program |
| Usual Care (UC) | Other | Other: InterventionWe will define UC as usual clinical care, which consists of diabetes management provider encounters (mean quarterly) plus monthly individual appointments with a pharm-Ds or nutritionists as clinically indicated. In addition, clinics offer multiple other individual and group opportunities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self-identified Latino(a)
- Spanish-speaking
- >/=18 years
- type 2 diabetes (T2D), e.g., HbA1c >/=6.5%, provider documented T2D, on oral anti-hyperglycemic
- uninsured, <150% federal poverty level
Key exclusion criteria (3 listed)
- no show to all group visits
- condition that may alter HbA1c levels, e.g., recent blood transfusion
- patients at high-risk or not appropriate for care in a group setting e.g., pregnancy, severe cognitive impairment, frequent clinic appointments for labile glucose/medication titration e.g., insulin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionIn the proposed study, we will conduct a randomized clinical trial of low-income, adult Latino(a)s with type 2 diabetes randomized at the individual level a telehealth-supported, integrated CHWs, medication-access, diabetes education program) (intervention) versus usual care (UC). Our research team will provide telementoring to local clinic teams (providers and CHWs) to initiate the 12-month the program into their clinics. | Other | Intervention, Usual Care (UC) |
Primary outcome
HbA1c (%)
Time frame: Baseline to 12-months
Compare intervention versus control HbA1c levels (%)
10 secondary outcomes
Systolic Blood Pressure mmHg
Time frame: Baseline to 12-months
Body Mass Index (BMI)
Time frame: Baseline to 12-months
Total Cholesterol
Time frame: Baseline to 12-months
American Diabetes Association (ADA) Adherence Measures: Diabetes Foot Exam
Time frame: Baseline to 12-months
ADA Adherence Measures: Diabetes Eye Exam Screening
Time frame: Baseline to 12-months
ADA Adherence Measures: Urine Microalbumin Screening
Time frame: Baseline to 12-months
ADA Adherence Measures: Flu Vaccination
Time frame: Baseline to 12-months
Average Score for CHW Support on Program Satisfaction Questionnaire
Time frame: 12-months
Attrition
Time frame: baseline to 12-months
Diastolic Blood Pressure mmHg
Time frame: baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42258200Vaughan EM, Yu X, Amspoker AB, Naik AD, Balasubramanyam A, Johnston CA, Ballantyne CM, Virani SS, Brown HS, Mena K, Porterfield LR. Structured Telehealth Community Health Worker-Clinician Feedback and Diabetes Outcomes: A Randomized Clinical Trial. JAMA Intern Med. 2026 Aug 1;186(8):1012-1021. doi: 10.1001/jamainternmed.2026.1917.
- Derived from this study: PubMed 40001087Ameri M, Jabbar LA, Kim S, Raji M, Samson SL, Vaughan EM. Training clinicians to facilitate diabetes group visits. BMC Med Educ. 2025 Feb 25;25(1):309. doi: 10.1186/s12909-025-06876-7.
- Derived from this study: PubMed 37351464Porterfield L, Warren V, Schick V, Gulliot-Wright S, Temple JR, Vaughan EM. Addressing Training Gaps: A Competency-Based, Telehealth Training Initiative for Community Health Workers. Telemed Rep. 2023 Jun 16;4(1):126-134. doi: 10.1089/tmr.2023.0007. eCollection 2023.
- Individual participant dataSharing planned: No. The NIH policy on data sharing does not apply to this protocol: (1) it is not basic research and involves human subjects, (2) it is anticipated that the data can be readily replicated as the purpose of the study is to train local clinics to conduct the program, (3) more than $500K in direct costs annually are not requested for any year of the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Vaughan, DO principal investigator
UTMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Diabetes Mellitus, Type 2, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (%) (time frame: Baseline to 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835493, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.