Testing a Diabetes Care Program in Rural and Low-Income Clinics

Официальное название

Implementing a Diabetes Intervention in Rural and Low-Income Clinics: A Feasibility Study

Обзор

The goal of this study is to evaluate a Community Health Worker (CHW) program for people living with diabetes in rural areas or locations that are remote from the research team. The study aims to answer the following questions: 1. Does the CHW program improve diabetes-related health outcomes, such as blood sugar control? 2. What is the sustainability of the program? 3. Is the program feasible and acceptable? Participants will be invited to attend monthly diabetes education classes led by CHWs and receive weekly mobile health check-ins from CHWs for coaching and to help coordinate care with their clinic team.

Подробное описание

Background:

Type 2 diabetes disproportionately affects low-income and Hispanic populations, who face barriers such as limited literacy, poverty, and lack of insurance. Prevalence is projected to rise, worsening disparities and increasing healthcare costs. Community Health Workers (CHWs) have been shown to improve diabetes outcomes by bridging patients and healthcare systems. Tele-mentoring CHWs allows interventions to be scaled geographically, but effectiveness in real-world clinics remains to be evaluated.

Objective \& Aims:

This 12-month, single-arm study implements a CHW-delivered diabetes intervention in community clinics distant from the parent research team.

Aim 1: Evaluate participant clinical outcomes (primary: HbA1c; secondary: blood pressure, cholesterol, BMI, and ADA adherence measures).

Aim 2: Monitor program sustainability through 36 months at the clinic level.

Aim 3: Assess implementation outcomes, including CHW knowledge, participant satisfaction, and attrition.

Inclusion/Exclusion:

Inclusion: Hispanic, Spanish-speaking adults ≥18 with type 2 diabetes and recent HbA1c.

Exclusion: Conditions affecting HbA1c, severe cognitive/mental illness, pregnancy, type 1 diabetes.

Study Design \& Procedures:

Design: Single-arm study; all consenting participants receive the intervention. Recruitment: Clinic database search (ICD-10 E11.x) and provider referrals; verbal consent obtained.

Intervention Phases:

Clinic readiness assessment CHW training via telehealth Tele-mentored CHW delivery of 12-month program (group classes, weekly mHealth coaching, participant-clinician feedback loop)

Sustainability assessment through month 36

CHWs: Hispanic, Spanish-fluent, trained and certified; supported by experienced CHW instructors.

Safety: CHWs identify urgent issues for clinicians; standard diabetes care guidelines followed; HIPAA compliance ensured.

Вмешательства

• Поведенческое Community Health Worker-led diabetes program
  The intervention consists of four phases: (1) clinic readiness assessment, (2) CHW training, (3) tele-mentoring CHWs to deliver the 12-month diabetes program, and (4) sustainability assessment through 36 months.

Первичные конечные точки

• Change in Hemoglobin A1c (HbA1c) [Срок оценки: baseline to 12 months]

Вторичные конечные точки (5)

• Change in Blood Pressure [Срок оценки: baseline to 12 months]
• Change in Cholesterol Levels [Срок оценки: baseline to 12 months]
• Change in Body Weight [Срок оценки: baseline to 12 months]
• Change in Body Mass Index (BMI) [Срок оценки: baseline to 12 months]
• Adherence to American Diabetes Association (ADA) Standards of Care [Срок оценки: baseline to 12 months]

Критерии участия

Критерии включения

• Self-identified Hispanic Ethnicity
• Spanish-speaking
• Type 2 diabetes diagnosis, .g., physician documented diagnosis, HbA1c at least 6.5, treatment with a glucose-lowering agent

Критерии исключения

• Condition known to alter HbA1c levels, e.g., recent transfusion, systemic steroids
• Severe mental illness or cognitive impairment that would preclude participation in group activities
• Pregnancy during the intervention period
• Type 1 diabetes mellitus

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Vaughan EM, Johnson E, Naik AD, Amspoker AB, Balasubramanyam A, Virani SS, Ballantyne CM, Johnston CA, Foreyt JP. Long-Term Effectiveness of the TIME Intervention to Improve Diabetes Outcomes in Low-Income Settings: a 2-Year Follow-Up. J Gen Intern Med. 2022 Sep;37(12):3062-3069. doi: 10.1007/s11606-021-07363-7. Epub 2022 Feb 7. PMID 35132555
• Vaughan EM, Virani S, Al Rifai M, Cardenas VJ Jr, Johnston CA, Porterfield L, Santiago Delgado Z, Samson SL, Schick V, Naik AD. Determining call-to-entry rate and recruitment barriers in clinical studies for community clinics serving low-income populations: a cohort study. BMJ Open. 2023 Oct 28;13(10):e077819. doi: 10.1136/bmjopen-2023-077819. PMID 37898484
• Vaughan EM, Cardenas VJ Jr, Chan W, Amspoker AB, Johnston CA, Virani SS, Ballantyne CM, Naik AD. Implementation and Evaluation of a mHealth-Based Community Health Worker Feedback Loop for Hispanics with and at Risk for Diabetes. J Gen Intern Med. 2024 Feb;39(2):229-238. doi: 10.1007/s11606-023-08434-7. Epub 2023 Oct 6. PMID 37803098
• Vaughan EM, Naik AD, Amspoker AB, Johnston CA, Landrum JD, Balasubramanyam A, Virani SS, Ballantyne CM, Foreyt JP. Mentored implementation to initiate a diabetes program in an underserved community: a pilot study. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002320. doi: 10.1136/bmjdrc-2021-002320. PMID 34385148
• Vaughan EM, Naik AD, Lewis CM, Foreyt JP, Samson SL, Hyman DJ. Telemedicine Training and Support for Community Health Workers: Improving Knowledge of Diabetes. Telemed J E Health. 2020 Feb;26(2):244-250. doi: 10.1089/tmj.2018.0313. Epub 2019 Mar 6. PMID 30839244
• Vaughan EM, Moreno JP, Hyman D, Chen TA, Foreyt JP. Efficacy of oral versus insulin therapy for newly diagnosed diabetes in low-income settings. Arch Gen Intern Med. 2017;1(2):17-22. PMID 29517061
• Vaughan EM, Johnston CA, Cardenas VJ, Moreno JP, Foreyt JP. Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study. Diabetes Educ. 2017 Dec;43(6):589-599. doi: 10.1177/0145721717737742. Epub 2017 Oct 19. PMID 29047326
• Vaughan EM, Hyman DJ, Naik AD, Samson SL, Razjouyan J, Foreyt JP. A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial. J Gen Intern Med. 2021 Feb;36(2):455-463. doi: 10.1007/s11606-020-06017-4. Epub 2020 Jul 22. PMID 32700217

Идентификаторы

NCT: NCT07538505 · 25-0360

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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