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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394456
• Other study ID #: H-40322
• Secondary ID: K23DK110341H-403
• Status: Completed
• Phase: N/A
• Start date: January 13, 2018
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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)
• 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

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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

Lujan J, Ostwald SK, Ortiz M. Promotora diabetes intervention for Mexican Americans. Diabetes Educ. 2007 Jul-Aug;33(4):660-70. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility and acceptability of telehealth patient, clinician encounters during diabetes group visits	As measured by the Telehealth Usability Questionnaire(21-question survey where 1 is strongly disagree and 5 is strongly agree)	At six months after group visits for wait list control Cohort 2
Other	Feasibility and acceptability of telehealth support for community health workers 2	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)	At baseline and six months during Cohort 1 intervention group
Other	Feasibility and acceptability of telemedicine support for community health workers	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)	After each cohort (every six months)
Other	Feasibility and acceptability of telemedicine support for community health workers	As measured by the Telehealth Usability Questionnaire(21-question survey where 1 is strongly disagree and 5 is strongly agree)	After Cohort 1
Other	CHW knowledge	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.	During Cohort 2 at baseline (TEST-1 pretest), 6- (TEST-1 posttest, TEST-2 pretest) and 12-months (TEST-2 posttest)
Other	CHW knowledge	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.	During the secondary study, at baseline and 6-months (pre/posttest)
Other	Access to care	As measured by the amount of contact participants had with the clinic during the intervention	from baseline to 12-months
Primary	Glycemic control	Hemoglobin A1c (%)	At baseline and every 6-months until study completion
Secondary	Adherence to preventive care guidelines	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.	pre/post diabetes group visits
Secondary	Survey	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.	at the beginning and end of each cohort (baseline, six-months)
Secondary	Diabetes-related health	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)	at the beginning and end of each cohort (baseline, six-months)
Secondary	Body Mass Index (BMI)	Body Mass Index (BMI) (weight in kg/height in m^2)	At baseline and every 6-month until study completion
Secondary	Blood Pressure	Blood Pressure (mmHg)	At baseline and every 6-month until study completion
Secondary	Barriers to care	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.	weekly to bimonthly from baseline to 12-months
Secondary	longitudinal outcomes	conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including blood pressure (mmHg)	from the time group visits end and as long as month-24 after
Secondary	longitudinal outcomes	conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including HbA1c (%)	from the time group visits end and as long as month-24 after
Secondary	longitudinal outcomes	conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including BMI (kg/m^2)	from the time group visits end and as long as month-24 after