NCT03394456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

January 13, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

4.6 years

First QC Date

December 21, 2017

Last Update Submit

September 27, 2022

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    Hemoglobin A1c (%)

    At baseline and every 6-months until study completion

Secondary Outcomes (9)

  • Adherence to preventive care guidelines

    pre/post diabetes group visits

  • Survey

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

  • Diabetes-related health

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

  • Body Mass Index (BMI)

    At baseline and every 6-month until study completion

  • Blood Pressure

    At baseline and every 6-month until study completion

  • +4 more secondary outcomes

Other Outcomes (7)

  • Feasibility and acceptability of telehealth patient, clinician encounters during diabetes group visits

    At six months after group visits for wait list control Cohort 2

  • Feasibility and acceptability of telehealth support for community health workers 2

    At baseline and six months during Cohort 1 intervention group

  • Feasibility and acceptability of telemedicine support for community health workers

    After each cohort (every six months)

  • +4 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Receive diabetes group visits/diabetes program

Other: diabetes programOther: telehealth training and support for Community Health Workers

Control

NO INTERVENTION

Receive 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

Interventions

diabetes programOTHER

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

Intervention
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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (9)

  • 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.

    PMID: 17881626BACKGROUND

  • 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.

    PMID: 24781097BACKGROUND

  • 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.

    PMID: 21658262BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 16681564BACKGROUND

  • 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.

    PMID: 17684167BACKGROUND

  • 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: 37898484DERIVED

  • 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: 37803098DERIVED

  • 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: 32700217DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Palliative CareCommunity Health Workers

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesAllied Health PersonnelHealth Personnel

Study Officials

  • Elizabeth Vaughan, DO

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
In the last secondary study, there is single blinding (data collectors)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2017

First Posted

January 9, 2018

Study Start

January 13, 2018

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)