Evaluating Telementoring for CHW-centered Diabetes Initiatives
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04835493 |
Recruitment Status :
Recruiting
First Posted : April 8, 2021
Last Update Posted : February 8, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Other: Intervention | Not Applicable |
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 in our TIME trial (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education). The TIME trial showed that individuals randomized to TIME 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 TIME 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=250; intervention=125) of low-income, adult Latino(a)s with type 2 diabetes randomized to TIME (intervention) versus usual care enhanced with education (EUC). Our research group will provide telementoring to local clinic teams to initiate TIME into their clinics. To evaluate efficacy, investigators will compare TIME versus EUC 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 TIME program acceptability and evaluation data for participants and clinic teams from baseline to 12-months (AIM 3). Investigators hypothesize that TIME participants will have superior and more sustainable clinical outcomes compared to EUC 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 TIME and strong evidence to improve the longitudinal care of low-income Latino(a)s with diabetes.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: |
|
Primary Purpose: | Treatment |
Official Title: | Evaluating Telementoring to Initiate a Multidimensional Diabetes Program for Latino(a)s in Community Clinics: A Randomized Clinical Trial |
Actual Study Start Date : | September 1, 2022 |
Estimated Primary Completion Date : | July 31, 2026 |
Estimated Study Completion Date : | July 31, 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Intervention individuals will receive the 12-month diabetes TIME program
|
Other: Intervention
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 to TIME (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education) (intervention) versus usual care enhanced with education (EUC). Our research team will provide telementoring to local clinic teams (providers and CHWs) to initiate the 12-month TIME program into their clinics. |
Enhanced Usual Care (EUC)
We will define EUC 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. In addition for the EUC arm, we will provide three quarterly, 1-hour classes (nutrition medications, exercise). The classes will be led by a research-staff trained, bilingual healthcare professional e.g., nurse. EUC individuals will not have contact with CHWs.
|
Other: Intervention
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 to TIME (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education) (intervention) versus usual care enhanced with education (EUC). Our research team will provide telementoring to local clinic teams (providers and CHWs) to initiate the 12-month TIME program into their clinics. |
- HbA1c [ Time Frame: Baseline to 12-months ]Compare TIME versus EUC HbA1c levels
- Blood pressure [ Time Frame: Baseline to 12-months ]Compare TIME versus blood pressure levels (systolic and diastolic)
- Body Mass Index (BMI) [ Time Frame: Baseline to 12-months ]Compare TIME versus EUC BMI levels
- Cholesterol [ Time Frame: Baseline to 12-months ]Compare TIME versus EUC cholesterol levels
- American Diabetes Association (ADA) adherence measures: Diabetes foot exam [ Time Frame: Baseline to 12-months ]Compare TIME versus EUC adherence to diabetes foot exams
- ADA adherence measures: B12 screening [ Time Frame: Baseline to 12-months ]Compare TIME versus EUC adherence to B12 screening
- ADA adherence measures: Diabetes eye exam [ Time Frame: Baseline to 12-months ]Compare TIME versus EUC adherence to diabetes eye exams
- ADA adherence measures: urine microalbumin screening [ Time Frame: Baseline to 12-months ]Compare TIME versus EUC adherence to urine microalbumin screening
- ADA adherence measures: flu vaccination [ Time Frame: Baseline to 12-months ]Compare TIME versus EUC adherence to flu vaccination
- ADA adherence measures: statin therapy [ Time Frame: Baseline to 12-months ]Compare TIME versus EUC adherence to statin therapy
- Sustainable clinical outcomes: HbA1c [ Time Frame: baseline to 36-months ]Compared to EUC, TIME will have more sustainable HbA1c levels
- Sustainable clinical outcomes: Blood pressure [ Time Frame: baseline to 36-months ]Compared to EUC, TIME will have more sustainable blood pressure levels (systolic and diastolic)
- Sustainable clinical outcomes: BMI [ Time Frame: baseline to 36-months ]Compared to EUC, TIME will have more sustainable BMI levels
- TIME satisfaction [ Time Frame: 12-months ]Anticipate >/=80% patient satisfaction as demonstrated by our 12-question satisfaction survey questions (on Likert scales of 1 to 10 (n=5 questions) where 10 is very satisfied and 1 is not at all satisfied and from 1-4 (n=3 questions) where 4 is very satisfied and 1 is not satisfied). There are three open-ended questions.
- Attrition [ Time Frame: baseline to 12-months ]Rate of attrition for TIME participants
- Community Health Worker (CHW) knowledge [ Time Frame: 12-months ]At 12-months; Knowledge as measured the CHW posttest, which includes 24-questions from the Star Education Study diabetes knowledge test, which has shown validity and reliability in English and Spanish and our TIME 25-question diabetes medication test that has been previously published. Tests are multiple choice with 4 possible answers.
- Telehealth Acceptibility [ Time Frame: 12-months ]Acceptability as measured by the Telehealth Usability Questionnaire, a 21-question survey of telehealth accepatibilty. Items are ranked on a 5-item scale (1 not acceptable, 5 very acceptable) and divided into six subsections that have shown good to excellent internal consistency.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835493
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Erika LeGross 409-266-9400 sponsored.research@utmb.edu |
Responsible Party: | Elizabeth Vaughan, Associate Professor, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT04835493 |
Other Study ID Numbers: |
H-49672 |
First Posted: | April 8, 2021 Key Record Dates |
Last Update Posted: | February 8, 2023 |
Last Verified: | February 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |