Clinical trial NCT04835493: Evaluating Telementoring for CHW-centered Diabetes Initiatives
Official title: Evaluating Telementoring to Initiate a Multidimensional Diabetes Program for Latino(a)s in Community Clinics: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
name: University of Houston
name: Baylor College of Medicine
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-04-08
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: Baseline to 12-months
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline to 12-months
measure: Body Mass Index (BMI)
timeFrame: Baseline to 12-months
measure: Cholesterol
timeFrame: Baseline to 12-months
measure: American Diabetes Association (ADA) adherence measures: Diabetes foot exam
timeFrame: Baseline to 12-months
measure: ADA adherence measures: B12 screening
timeFrame: Baseline to 12-months
measure: ADA adherence measures: Diabetes eye exam
timeFrame: Baseline to 12-months
measure: ADA adherence measures: urine microalbumin screening
timeFrame: Baseline to 12-months
measure: ADA adherence measures: flu vaccination
timeFrame: Baseline to 12-months
measure: ADA adherence measures: statin therapy
timeFrame: Baseline to 12-months
measure: Sustainable clinical outcomes: HbA1c
timeFrame: baseline to 36-months
measure: Sustainable clinical outcomes: Blood pressure
timeFrame: baseline to 36-months
measure: Sustainable clinical outcomes: BMI
timeFrame: baseline to 36-months
measure: Program satisfaction
timeFrame: 12-months
measure: Attrition
timeFrame: baseline to 12-months
measure: Community Health Worker (CHW) knowledge
timeFrame: 12-months
measure: Telehealth Acceptability
timeFrame: 12-months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: UTMB
name: Elizabeth Vaughan, DO
role: PRINCIPAL_INVESTIGATOR
References: