We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03394456
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study evaluates the effect of diabetes group visits that are led by Community Health Workers (CHWs). Half of the subjects will be randomized to receive a 6-month, CHW-led group visit program (intervention) and the other half will be randomized to receive 6-months of treatment as usual in the clinic followed by the group visit program (wait list control). The CHWs will receive training and support via telemedicine.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Other: diabetes group visits Other: telemedicine support for Community Health Workers

Detailed Description:
The number of Hispanics diagnosed with diabetes is escalating in the US with disproportionately higher prevalence and complication rates than other ethnicities. Community Health Workers (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. Telemedicine 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 telemedicine 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. In a pilot study, the investigators initiated a CHW-led diabetes program for resource-poor Hispanics with in-person support for CHWs. The current study utilizes pilot data to evaluate the use of telemedicine support for CHWs who lead diabetes programs for resource-poor Hispanics. Specifically, the investigators will conduct a randomized controlled trial in 4 cohort waves with 176 adults diagnosed with type 2 diabetes. The study will compare clinical outcomes and treatment satisfaction of subjects who receive a CHW-led diabetes group visit program incorporating telemedicine support (intervention, n=88) to subjects who receive usual care (wait list control, n=88). In addition, we will analyze the acceptability of telemedicine use for CHWs.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Technology to Improve the Health of Resource-poor Hispanics With Diabetes
Anticipated Study Start Date : January 13, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : March 31, 2022
Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention
Receive diabetes group visits
Other: diabetes group visits
Comprehensive monthly diabetes group visits led by community health workers who are supported by telemedicine
Other: telemedicine support for Community Health Workers
weekly 1-hour diabetes training and patient support for CHWs via telemedicine i.e., ZOOM technology
No Intervention: Control
Receive usual care in the clinic, followed by group visits (wait list control)

Outcome Measures

Primary Outcome Measures :
  1. Diabetes Clinical Outcome 1: Hemoglobin A1c [ Time Frame: Six months per cohort. Four cohorts total ]
    Hemoglobin A1c (%)

  2. Diabetes Clinical Outcome 2: Body Mass Index (BMI) [ Time Frame: Six months per cohort. Four cohorts total ]
    Body Mass Index (BMI) (weight in kg/height in m^2)

  3. Diabetes Clinical Outcome 3: Blood Pressure [ Time Frame: Six months per cohort. Four cohorts total ]
    Blood Pressure (mmHg)

Secondary Outcome Measures :
  1. Diabetes-related emotional distress [ Time Frame: Six months per cohort. Four cohorts total ]
    As measured by the Problem Areas in Diabetes (PAID)-5 questionnaire (PAID-5 is 5 questions; each item ranges from 0 to 4 where 0 is not a problem and 4 is a serious problem; a total score of 8 or greater suggests possible diabetes-related emotional distress and further evaluation is recommended).

Other Outcome Measures:
  1. Feasibility and acceptability of telemedicine support for community health workers 1 [ Time Frame: Six months per cohort. Four cohorts total ]
    as measured by the Teacher Self-Efficacy survey (Schwarzer et al, 1999; 10 questions; scale 1 to 4 where 1 is not at all true and 4 is exactly true; total range 10 to 40)

  2. Feasibility and acceptability of telemedicine support for community health workers 2 [ Time Frame: Six months per cohort. Four cohorts total ]
    The Diabetes Knowledge Test (University of Michigan, 2015; 23 questions; where a total score of 0 indicates the least and 23 indicates the most diabetes knowledge based on this test)

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Hispanic adults with diabetes

Exclusion Criteria:

  • group visit is not appropriate for care i.e., need individualized care, pregnancy, etc
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394456

Contact: Elizabeth Vaughan, DO 1-713-873-3560 Elizabeth.vaughan@bcm.edu

United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Elizabeth Vaughan, DO    713-873-3560    Elizabeth.vaughan@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Elizabeth Vaughan, DO Baylor College of Medicine
More Information

Responsible Party: Elizabeth Vaughan, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03394456     History of Changes
Other Study ID Numbers: K23DK110341 ( U.S. NIH Grant/Contract )
H-40322 ( Other Identifier: Baylor College of Medicine IRB )
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases