Evaluating Telementoring for CHW-centered Diabetes Initiatives

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04835493
• Other study ID #: 22-0224
• Secondary ID: R01DK129474
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: July 31, 2028

Study information

• Verified date: May 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: Elizabeth M. Vaughan
• Phone: 409.772.7399
• Email: emvaugha[@]utmb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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 a telehealth-supported, integrated CHWs, medication-access, diabetes education program) (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 the program into their clinics.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Houston	Texas

Sponsors (5)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Compare intervention versus control HbA1c levels	Baseline to 12-months
Secondary	Blood pressure	Compare intervention versus control blood pressure levels (systolic and diastolic)	Baseline to 12-months
Secondary	Body Mass Index (BMI)	Compare intervention versus control BMI levels	Baseline to 12-months
Secondary	Cholesterol	Compare intervention versus control cholesterol levels	Baseline to 12-months
Secondary	American Diabetes Association (ADA) adherence measures: Diabetes foot exam	Compare intervention versus control adherence to diabetes foot exams	Baseline to 12-months
Secondary	ADA adherence measures: B12 screening	Compare intervention versus control adherence to B12 screening	Baseline to 12-months
Secondary	ADA adherence measures: Diabetes eye exam	Compare intervention versus control adherence to diabetes eye exams	Baseline to 12-months
Secondary	ADA adherence measures: urine microalbumin screening	Compare intervention versus control adherence to urine microalbumin screening	Baseline to 12-months
Secondary	ADA adherence measures: flu vaccination	Compare intervention versus control adherence to flu vaccination	Baseline to 12-months
Secondary	ADA adherence measures: statin therapy	Compare intervention versus control adherence to statin therapy	Baseline to 12-months
Secondary	Sustainable clinical outcomes: HbA1c	Compared to control, the intervention will have more sustainable HbA1c levels	baseline to 36-months
Secondary	Sustainable clinical outcomes: Blood pressure	Compared to control, the intervention will have more sustainable blood pressure levels (systolic and diastolic)	baseline to 36-months
Secondary	Sustainable clinical outcomes: BMI	Compared to control, the intervention will have more sustainable BMI levels	baseline to 36-months
Secondary	Program satisfaction	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.	12-months
Secondary	Attrition	Rate of attrition for intervention participants	baseline to 12-months
Secondary	Community Health Worker (CHW) knowledge	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.	12-months
Secondary	Telehealth Acceptability	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.	12-months