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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394456
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : April 21, 2022
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 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: diabetes program Other: telehealth training and 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. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: In the last secondary study, there is single blinding (data collectors)
Primary Purpose: Treatment
Official Title: Technology to Improve the Health of Resource-poor Hispanics With Diabetes
Actual Study Start Date : January 13, 2018
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : March 31, 2022

Arm Intervention/treatment
Experimental: Intervention
Receive diabetes group visits/diabetes program
Other: diabetes program
Comprehensive diabetes program (weekly to bimonthly CHW mHealth contact (phone, text) for 12-months and monthly diabetes group visits for 6-months)

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

No Intervention: Control
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



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


Secondary Outcome Measures :
  1. Adherence to preventive care guidelines [ Time Frame: pre/post diabetes group visits ]
    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.

  2. Survey [ Time Frame: at the beginning and end of each cohort (baseline, six-months) ]
    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.

  3. 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-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)

  4. 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)

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

  6. Barriers to care [ Time Frame: weekly to bimonthly from baseline to 12-months ]
    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.

  7. longitudinal outcomes [ Time Frame: from the time group visits end and as long as month-24 after ]
    conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including blood pressure (mmHg)

  8. longitudinal outcomes [ Time Frame: from the time group visits end and as long as month-24 after ]
    conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including HbA1c (%)

  9. longitudinal outcomes [ Time Frame: from the time group visits end and as long as month-24 after ]
    conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including BMI (kg/m^2)


Other Outcome Measures:
  1. Feasibility and acceptability of telehealth patient, clinician encounters during diabetes group visits [ Time Frame: At six months after group visits for wait list control Cohort 2 ]
    As measured by the Telehealth Usability Questionnaire(21-question survey where 1 is strongly disagree and 5 is strongly agree)

  2. Feasibility and acceptability of telehealth support for community health workers 2 [ Time Frame: At baseline and six months during Cohort 1 intervention group ]
    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: After Cohort 1 ]
    As measured by the Telehealth Usability Questionnaire(21-question survey where 1 is strongly disagree and 5 is strongly agree)

  5. CHW knowledge [ Time Frame: During Cohort 2 at baseline (TEST-1 pretest), 6- (TEST-1 posttest, TEST-2 pretest) and 12-months (TEST-2 posttest) ]
    As measured by pre- /post-tests. TEST-1 (n=21 questions) and TEST-2 (n=19 questions). Tests were multiple choice with 3-5 answer option and were original to this study.

  6. CHW knowledge [ Time Frame: During the secondary study, at baseline and 6-months (pre/posttest) ]
    This will be accomplished by the 24-question Starr County Diabetes Knowledge Test, which has shown validity and reliability in English and Spanish. Each of the 24-question has three answer choices. This will be pre/posttest format.

  7. Access to care [ Time Frame: from baseline to 12-months ]
    As measured by the amount of contact participants had with the clinic during the intervention



Information from the National Library of Medicine

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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


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Elizabeth Vaughan, DO Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Elizabeth Vaughan, Baylor College of Medicine:
Informed Consent Form  [PDF] October 6, 2020

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elizabeth Vaughan, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03394456    
Other Study ID Numbers: H-40322
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: April 21, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases