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Diabetes Mellitus, Type 2NCT03394456

Technology to Improve the Health of Resource-poor Hispanics With Diabetes

A study testing diabetes program and telehealth training and support for Community Health Workers in people with Diabetes Mellitus, Type 2, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
diabetes program and telehealth training and support for Community Health Workers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
1 siteUnited States
Study dates
13 Jan 2018to 30 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the 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.

Being tested
diabetes program, telehealth training and support for Community Health Workers
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diabetes programOther

    Comprehensive diabetes program (weekly to bimonthly CHW mHealth contact (phone, text) for 12-months and monthly diabetes group visits for 6-months)

  • telehealth training and support for Community Health WorkersOther

    weekly 1-hour diabetes training and patient support for CHWs via telehealth i.e., ZOOM technology for the study duration

Study groups in NCT03394456
Study groupRoleWhat they receive
InterventionExperimentalReceive diabetes group visits/diabetes program
Receives: Other: diabetes program; Other: telehealth training and support for Community Health Workers
ControlNo interventionReceive usual care in the clinic, followed by group visits (wait list control) for cohorts 1-4 case-matched comparisons via chart review for cohort 5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic control

    Hemoglobin A1c (%)

    Measured: At baseline and every 6-months until study completion

Secondary outcomes (9)

  1. Adherence to preventive care guidelines

    As measured by placement on a statin, annual urine micro albumin, target A1c, weight loss (if applicable), retinal eye examination, blood pressure targets, serum B12 measurements, vaccinations.

    Measured: pre/post diabetes group visits

  2. Survey

    The survey totaled 12 questions and assessed participant satisfaction, mental relaxation, faith/spirituality, and open-ended comments. Questions were ranked as followed: 1-3 (4-point Likert Scale), 4-7 (10-point Likert Scale), 8-11 (open-ended, descriptive), 12 (days of exercise/week). The Use of Mental Stress Management/Relaxation Techniques questionnaire and our pilot study survey templates were used to evaluate patient group visit and CHW satisfaction. We defined acceptability as high (3.5-4/4 or 8-10/10), moderate (2-3.4/4 or 4-7/10), and low (1-1.9/4 or 1-3/10) and totaled the items to create an overall score.

    Measured: at the beginning and end of each cohort (baseline, six-months)

  3. Diabetes-related health

    As measured by the Self Management Resource Center Surveys: Diabetes Medications (a 4-question yes/no survey to assess patient medication adherence and understanding of their medications), Self-rated Health (a 1-question ranked on a 5-point scale (1 is excellent, 5 is poor) to determine the patient's view of their health)

    Measured: at the beginning and end of each cohort (baseline, six-months)

  4. Body Mass Index (BMI)

    Body Mass Index (BMI) (weight in kg/height in m^2)

    Measured: At baseline and every 6-month until study completion

  5. Blood Pressure

    Blood Pressure (mmHg)

    Measured: At baseline and every 6-month until study completion

  6. Barriers to care

    We obtain barriers to care data from the CHW-patient mobile health (mHealth) records and chart review, and group into three categories: obtaining medications, appointment access, clinic eligibility. mHealth records were sent to the study physician through a secure, encrypted site on a weekly basis.

    Measured: weekly to bimonthly from baseline to 12-months

  7. longitudinal outcomes

    conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including blood pressure (mmHg)

    Measured: from the time group visits end and as long as month-24 after

  8. longitudinal outcomes

    conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including HbA1c (%)

    Measured: from the time group visits end and as long as month-24 after

  9. longitudinal outcomes

    conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including BMI (kg/m^2)

    Measured: from the time group visits end and as long as month-24 after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2018
  2. Study start13 Jan 2018
  3. Primary completion30 Aug 2022
  4. Study completion30 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03394456
Sponsor's protocol ID
H-40322
Other IDs
K23DK110341, H-40322
Status last verified
Sep 2022
First submitted
21 Dec 2017
Last updated
28 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17881626

  • 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.

    PubMed 24781097

  • 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.

    PubMed 21658262

  • Furino A. Community Health Worker National Workforce Study. Wasthington, DC: US Dept of Health and Human Services; 2007.

  • 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.

    PubMed 16681564

  • 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.

    PubMed 17684167

  • 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.

    PubMed 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.

    PubMed 37803098

  • 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.

    PubMed 32700217

Questions about this trial

What is this clinical trial studying?

A study testing diabetes program and telehealth training and support for Community Health Workers in people with Diabetes Mellitus, Type 2, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic control (time frame: At baseline and every 6-months until study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03394456, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.

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