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

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ClinicalTrials.gov Identifier: NCT03394456
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Elizabeth Vaughan, Baylor College of Medicine

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 Phase
Diabetes Mellitus, Type 2 Other: diabetes group visits Other: telemedicine support for Community Health Workers Not Applicable

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 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
Actual Study Start Date : January 13, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : March 31, 2022

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)



Primary Outcome Measures :
  1. Glycemic control [ Time Frame: At baseline and every 6-month until study completion ]
    Hemoglobin A1c (%)


Secondary Outcome Measures :
  1. Diabetes-related distress [ Time Frame: Six months per cohort. Four cohorts total ]
    As measured by the Health Management Resource Center Health Distress survey (4 questions where 0 is none of the time and 5 is all of the time) and 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).

  2. Adherence to preventive care guidelines [ Time Frame: During six-month intervention. ]
    As measured by placement on a statin, annual urine micro albumin, target A1c, weight loss (if applicable), retinal eye examination, serum B12 measurements, vaccinations.

  3. Patient acceptability of a diabetes class where community health workers are support by telehealth [ Time Frame: At 6-months ]
    As measured by a 10 question survey. Three questions are related to the satisfaction of the class (scale of 1 to 4, 1 is not satisfied, 4 is very satisfied), 4 questions are related to the CHWs and overall health/recommendation (scale of 1 to 10, where 1 is not satisfied and 10 is very satisfied), and 3 open ended questions to evaluate what they liked, would want to change, or any general comments.

  4. Diabetes-related health [ Time Frame: at the beginning and end of each cohort (baseline, six-months) ]
    As measured by the Self Management Resource Center Surveys: Diabetes Medications (a 4 yes/no survey to assess patient medication adherence and understanding of their medications), mental stress management (a 1-question survey to determine the amount and type of relaxation a patient does), 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)

  5. Body Mass Index (BMI) [ Time Frame: At baseline and every 6-month until study completion ]
    Body Mass Index (BMI) (weight in kg/height in m^2)

  6. Blood Pressure [ Time Frame: At baseline and every 6-month until study completion ]
    Blood Pressure (mmHg)


Other Outcome Measures:
  1. Feasibility and acceptability of telemedicine support for community health workers 1 [ Time Frame: After each cohort (every six months) ]
    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: At baseline and six months ]
    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)

  3. Feasibility and acceptability of telemedicine support for community health workers [ Time Frame: After each cohort (every six months) ]
    As measured by a six-month 4-question survey (four open-ended questions i.e., what CHWs liked, disliked, general comments) and a 10-question multiple choice posttest that covers content they were taught the last six months (Vaughan et al, 2018)

  4. Feasibility and acceptability of telemedicine support for community health workers [ Time Frame: At six months ]
    As measured by the Telehealth Usability Questionnaire(21-question survey where 1 is strongly disagree and 5 is strongly agree)



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

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


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

Locations
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)
Investigators
Principal Investigator: Elizabeth Vaughan, DO Baylor College of Medicine

Publications:
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 )
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: July 23, 2018
Last Verified: July 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