Clinical trial NCT03394456: Technology to Improve the Health of Resource-poor Hispanics With Diabetes
Official title: Technology to Improve the Health of Resource-poor Hispanics With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-01-09
Enrollment: 265
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: This study evaluates the efficacy and implementation of a telehealth-supported, integrated diabetes group visit program led by Community Health Workers (CHWs). Primary study relates to efficacy and a secondary study addresses mentored implementation.

Detailed description: The number of Hispanics diagnosed with diabetes is escalating in the US with disproportionately higher prevalence and complication rates than other ethnicities. CHWs are a well-established and culturally sensitive means to bridge gaps in care to individuals with diabetes. However CHWs are often left unsupported, placing patients at risk of substandard care or harm. Telehealth is a term used to describe a range of technologies to support healthcare delivery via communication with the patient or a member of the healthcare delivery team. Though telehealth has been implemented into diabetes programs for many years, there is a paucity of data showing the use of telemedicine for CHW training and support.

The primary study (n=89; Cohorts 1,2) compares clinical outcomes and treatment satisfaction of individuals who receive diabetes care in a 12-month telehealth supported, integrated CHW-led group visit program compared to those in usual care (wait list control). Group visits are 6-months and CHWs contact patients weekly to bimonthly (mobile health (mHealth)) for 12-months. This phase with have two cohort waves, separated by 6-months. The wait list control group for Cohort 2 will explore telehealth, clinician-patient encounters. A secondary study (n=59; Cohorts 3,4) at a new clinic evaluates the ability to implement the program. In the first phase of the secondary study the research team will conduct a RCT of individuals randomized to the diabetes program (intervention) vs usual care (control) to assess clinic feasibility. The clinic team will observe this process and learn the project protocols during Phase 1. In the second phase, the clinic team will lead the group visits while the research team mentors them to conduct the project in-person at the group visits and via telehealth each week (ZOOM video conferencing). Another secondary study (n=138; Cohort 5) aims to expand the reach of the education and CHW intervention for individuals who may not be able to or cannot come to the clinic for group visits. Specifically, individuals will received the education from the program monthly via a secure text message video, CHWs will contact weekly to bimonthly to advocate for their needs, and participants will receive their routine care as usual in the clinic.

Eligibility criteria: Inclusion Criteria:

* Hispanic adults with diabetes, low-income (earn less than/equal to 250% federal poverty level)

Exclusion Criteria:

* not able to understand Spanish, group visit is not appropriate for care i.e., need individualized care, pregnancy, etc

Primary outcomes:
measure: Glycemic control
timeFrame: At baseline and every 6-months until study completion
Secondary outcomes:
measure: Adherence to preventive care guidelines
timeFrame: pre/post diabetes group visits
measure: Survey
timeFrame: at the beginning and end of each cohort (baseline, six-months)
measure: Diabetes-related health
timeFrame: at the beginning and end of each cohort (baseline, six-months)
measure: Body Mass Index (BMI)
timeFrame: At baseline and every 6-month until study completion
measure: Blood Pressure
timeFrame: At baseline and every 6-month until study completion
measure: Barriers to care
timeFrame: weekly to bimonthly from baseline to 12-months
measure: longitudinal outcomes
timeFrame: from the time group visits end and as long as month-24 after
measure: longitudinal outcomes
timeFrame: from the time group visits end and as long as month-24 after
measure: longitudinal outcomes
timeFrame: from the time group visits end and as long as month-24 after
Other outcomes:
measure: Feasibility and acceptability of telehealth patient, clinician encounters during diabetes group visits
timeFrame: At six months after group visits for wait list control Cohort 2
measure: Feasibility and acceptability of telehealth support for community health workers 2
timeFrame: At baseline and six months during Cohort 1 intervention group
measure: Feasibility and acceptability of telemedicine support for community health workers
timeFrame: After each cohort (every six months)
measure: Feasibility and acceptability of telemedicine support for community health workers
timeFrame: After Cohort 1
measure: CHW knowledge
timeFrame: During Cohort 2 at baseline (TEST-1 pretest), 6- (TEST-1 posttest, TEST-2 pretest) and 12-months (TEST-2 posttest)
measure: CHW knowledge
timeFrame: During the secondary study, at baseline and 6-months (pre/posttest)
measure: Access to care
timeFrame: from baseline to 12-months
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Elizabeth Vaughan, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.
citation: Dias S, Gama A. [Community-based participatory research in public health: potentials and challenges]. Rev Panam Salud Publica. 2014 Feb;35(2):150-4. Portuguese.
citation: Mbuagbaw L, Thabane L, Ongolo-Zogo P, Lang T. The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial. Trials. 2011 Jun 9;12:145. doi: 10.1186/1745-6215-12-145.
citation: Furino A. ￼Community Health Worker National Workforce Study. Wasthington, DC: US Dept of Health and Human Services; 2007.
citation: Norris SL, Chowdhury FM, Van Le K, Horsley T, Brownstein JN, Zhang X, Jack L Jr, Satterfield DW. Effectiveness of community health workers in the care of persons with diabetes. Diabet Med. 2006 May;23(5):544-56. doi: 10.1111/j.1464-5491.2006.01845.x.
citation: Lujan J, Ostwald SK, Ortiz M. Promotora diabetes intervention for Mexican Americans. Diabetes Educ. 2007 Jul-Aug;33(4):660-70. doi: 10.1177/0145721707304080.
citation: 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.