Working...
ClinicalTrials.gov
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 : 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

Tracking Information
First Submitted Date  ICMJE December 21, 2017
First Posted Date  ICMJE January 9, 2018
Last Update Posted Date July 23, 2018
Actual Study Start Date  ICMJE January 13, 2018
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
Glycemic control [ Time Frame: At baseline and every 6-month until study completion ]
Hemoglobin A1c (%)
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
  • Diabetes Clinical Outcome 1: Hemoglobin A1c [ Time Frame: Six months per cohort. Four cohorts total ]
    Hemoglobin A1c (%)
  • 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)
  • Diabetes Clinical Outcome 3: Blood Pressure [ Time Frame: Six months per cohort. Four cohorts total ]
    Blood Pressure (mmHg)
Change History Complete list of historical versions of study NCT03394456 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • 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).
  • 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.
  • 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.
  • 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)
  • 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)
  • Blood Pressure [ Time Frame: At baseline and every 6-month until study completion ]
    Blood Pressure (mmHg)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
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).
Current Other Pre-specified Outcome Measures
 (submitted: July 20, 2018)
  • 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)
  • 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)
  • 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)
  • 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)
Original Other Pre-specified Outcome Measures
 (submitted: January 3, 2018)
  • 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)
  • 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)
 
Descriptive Information
Brief Title  ICMJE Technology to Improve the Health of Resource-poor Hispanics With Diabetes
Official Title  ICMJE Technology to Improve the Health of Resource-poor Hispanics With Diabetes
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Intervention
    Receive diabetes group visits
    Interventions:
    • Other: diabetes group visits
    • Other: telemedicine support for Community Health Workers
  • No Intervention: Control
    Receive usual care in the clinic, followed by group visits (wait list control)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2018)
176
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elizabeth Vaughan, DO 1-713-873-3560 Elizabeth.vaughan@bcm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03394456
Other Study ID Numbers  ICMJE K23DK110341( U.S. NIH Grant/Contract )
K23DK110341 ( U.S. NIH Grant/Contract )
H-40322 ( Other Identifier: Baylor College of Medicine IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Elizabeth Vaughan, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Elizabeth Vaughan, DO Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP