Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04835493

Evaluating Telementoring for CHW-centered Diabetes Initiatives

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention

Other

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.

Primary outcomes

  1. HbA1c

    Time frame: Baseline to 12-months

    Compare intervention versus control HbA1c levels

Secondary outcomes

  1. Blood pressure

    Time frame: Baseline to 12-months

    Compare intervention versus control blood pressure levels (systolic and diastolic)

  2. Body Mass Index (BMI)

    Time frame: Baseline to 12-months

    Compare intervention versus control BMI levels

  3. Cholesterol

    Time frame: Baseline to 12-months

    Compare intervention versus control cholesterol levels

  4. American Diabetes Association (ADA) adherence measures: Diabetes foot exam

    Time frame: Baseline to 12-months

    Compare intervention versus control adherence to diabetes foot exams

  5. ADA adherence measures: B12 screening

    Time frame: Baseline to 12-months

    Compare intervention versus control adherence to B12 screening

  6. ADA adherence measures: Diabetes eye exam

    Time frame: Baseline to 12-months

    Compare intervention versus control adherence to diabetes eye exams

  7. ADA adherence measures: urine microalbumin screening

    Time frame: Baseline to 12-months

    Compare intervention versus control adherence to urine microalbumin screening

  8. ADA adherence measures: flu vaccination

    Time frame: Baseline to 12-months

    Compare intervention versus control adherence to flu vaccination

  9. ADA adherence measures: statin therapy

    Time frame: Baseline to 12-months

    Compare intervention versus control adherence to statin therapy

  10. Sustainable clinical outcomes: HbA1c

    Time frame: baseline to 36-months

    Compared to control, the intervention will have more sustainable HbA1c levels

  11. Sustainable clinical outcomes: Blood pressure

    Time frame: baseline to 36-months

    Compared to control, the intervention will have more sustainable blood pressure levels (systolic and diastolic)

  12. Sustainable clinical outcomes: BMI

    Time frame: baseline to 36-months

    Compared to control, the intervention will have more sustainable BMI levels

  13. Program 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.

  14. Attrition

    Time frame: baseline to 12-months

    Rate of attrition for intervention participants

  15. 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.

  16. Telehealth Acceptability

    Time frame: 12-months

    Acceptability as measured by the Telehealth Usability Questionnaire, a 21-question survey of telehealth acceptability. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • Baylor College of Medicine
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • The University of Texas Health Science Center, Houston
  • University of Houston

Registry information

Official study title

Evaluating Telementoring to Initiate a Multidimensional Diabetes Program for Latino(a)s in Community Clinics: A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.