Mil Familias-Santa Barbara's Operational Pilot to Understand Diabetes in the Latino Community (MilFamilias)
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|ClinicalTrials.gov Identifier: NCT03736486|
Recruitment Status : Enrolling by invitation
First Posted : November 9, 2018
Last Update Posted : December 11, 2018
|Condition or disease|
|Type2 Diabetes Mellitus Cardiovascular Diseases|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Mil Familias- Santa Barbara Operational Pilot|
|Actual Study Start Date :||August 24, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Type 2 Diabetes
Male and female adults of Hispanic and/or Latino heritage with an established diagnosis of Type 2 diabetes.
- Success (evaluated by Yes/No format) recruiting and establishing a pilot cohort of 100 Latino adults with Type 2 Diabetes and creating data collection methods to describe genetics, biology, behavior, psychology, & environment in Type 2 Diabetes [ Time Frame: 1 year ]Mil Familias Program Pilot will measure genetic influences by a family medical history & biobank blood samples. Biologic influences will include laboratory blood draw, physical exam with vital signs & waist circumference measurement, and complete medical & medication history with female menopause, pregnancy, & gestational diabetes status. Behavior influences will include sleep, stress, drug abuse, and diabetes self-assessment management questionnaires. Wearable devices will measure physical activity. Psychological influences will include Patient Health Questionnaire-9, Brief Perceived Ethnic Discrimination Questionnaire Community Version, and Short Form Health Survey. Social/environmental influences will include socio-demographics, Brief Acculturation Scale for Hispanics, personal opinions about type 2 diabetes, and questionnaires [Short Assessment of Health Literacy, Trust in Physician, Health Leads Screening Toolkit, and U.S. Household Food Security Survey].
- Socio-demographics measured by questionnaire - including age, gender, race/ethnicity, contact information, number in household, income, education, marital status, occupation, insurance status, immigration status, alcohol & tobacco use, and birth place [ Time Frame: Beginning of study - Baseline visit 1 ]Socio-demographics assessed by questionnaire.
- Self-assessment of diabetes management measured by the American Diabetes Association questionnaire, Participant Self-Assessment of Diabetes Management [ Time Frame: Beginning of study - Baseline visit 1 ]Participant report and self-assessment of diabetes management by questionnaire
- Food security assessed by U.S. Household Food Security Survey Module: Six-item short form [ Time Frame: Beginning of study - Baseline visit 1 ]Food security or insecurity assessed by a six-item short form developed by the Economic Research Service, United States Department of Agriculture (USDA), September 2012
- Social needs screening assessed by the Health Leads Screening Toolkit [ Time Frame: Beginning of study - Baseline visit 1 ]The Health Leads Screening Tookit (Boston, MA) will be used to determine social needs
- Number of visits to a healthcare provider in the last year and difficulty in traveling to a healthcare provider measured by electronic medical record and interview [ Time Frame: Beginning of study - Baseline visit 1 ]Number of healthcare visits assessed in medical record review and the difficulty in traveling to the healthcare provider assessed by questionnaire
- Personal opinion regarding type 2 diabetes burden on Latinos measured by 3 questions - why is diabetes common in Latinos, what can be done to prevent diabetes in Latinos, and what things make it difficult to get help with diabetes when it is needed? [ Time Frame: Beginning of study - Baseline visit 1 ]Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions
- Support for diabetes care measured by questionnaire adapted from the American Diabetes Association Participant Self-Assessment of Diabetes Management questionnaire [ Time Frame: Beginning of study - Baseline visit 1 ]How well a participant is supported in diabetes care measured by a questionnaire from the American Diabetes Association (ADA) Participant Self-Assessment of Diabetes Management questionnaire
- Medical history, family medical history, and medication status and history assessed by interview and electronic medical records [ Time Frame: Day 1 of Visit 2 ]Medical history, family medical history, and current medications and medication history assessed by interview and electronic medical records
- Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview and electronic medical records [ Time Frame: Day 1 of Visit 2 ]Menopausal status, pregnancy status, and gestational diabetes history for female participants will be determined by interview and electronic medical records
- Measurement by composite physical exam - height, weight, waist circumference, blood pressure, temperature, heart rate & rhythm, and foot examination including questions about neuropathy and retinopathy and dental & eye exams [ Time Frame: Day 1 of Visit 2 ]Physical exam with vital signs and questions about neuropathy, retinopathy, dental, and eye exams
- Composite lab tests: C-Peptide, C-reactive protein, Complete blood count, Comprehensive metabolic panel, Glutamic Acid Decarboxylase (GAD) antibodies, HbA1c, Insulin autoantibody, Lipid panel, Insulin, and Thyroid function [ Time Frame: Day 1 of Visit 2 ]Laboratory blood draw for evaluation of physiological markers related to diabetes
- Microalbumin, creatinine, and microalbumin/creatinine ratio measured in a urine sample [ Time Frame: Day 1 of Visit 2 ]Urine sample collected for measuring microalbumin, creatinine, and the microalbumin/creatinine ratio
- Depression measured by the Patient Health Questionnaire-9 [ Time Frame: Day 1 of Visit 2 ]The Patient Health Questionnaire (PHQ)-9 is the Major Depressive Disorder (MDD) module of the full PHQ
- Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20 [ Time Frame: Day 1 of Visit 2 ]The purpose of the DAST-20 is to provide a brief, simple, practical, but valid method for identifying individuals who are abusing psychoactive drugs; and to yield a quantitative index score of the degree of problems related to drug use and misuse
- Physical activity measured by two wearable physical activity monitors for 1 week [ Time Frame: 1 week ]Participants wear an ActiGraph and Fitbit activity monitors simultaneously for 1 week
- Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH) [ Time Frame: Day 1 of Visit 3 ]BASH is a participant reported questionnaire to measure acculturation
- Health literacy measured by the Short Assessment of Health Literacy (SAHL) [ Time Frame: Day 1 of Visit 3 ]SAHL is a participant reported questionnaire to measure health literacy
- Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV) [ Time Frame: Day 1 of Visit 3 ]PEDQ-CV is a participant reported questionnaire to measure perceived ethnic discrimination
- Stress measured by the 4 item Perceived Stress Scale (PSS) [ Time Frame: Day 1 of Visit 3 ]PSS is a participant reported questionnaire to measure stress
- Quality of life measured by the Short Form Health Survey (SF-12) [ Time Frame: Day 1 of Visit 3 ]The SF-12 is a participant reported questionnaire to measure quality of life
- Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ) [ Time Frame: Day 1 of Visit 3 ]The OSQ is a participant reported questionnaire to measure sleep quality
- Trust in physician measured by the Trust in Physician (TPS) questionnaire [ Time Frame: Day 1 of Visit 3 ]The TPS is a questionnaire and scale to determine trust in the physician
- Engagement of a local consortium of partners to implement participant recruitment; data collection, storage, and analysis; healthcare access; and/or intervention measured by the number of major operational partnerships with formal agreements [ Time Frame: 1 year ]A local consortium of partners will be engaged with formal operational partnerships that include signed agreements and statements of work. These partnerships will include local health clinics and providers, the county, Hispanic/Latino community groups, other non-profit groups involved with the Hispanic/Latino community, and health promoters such as the Young Men's Christian Association (YMCA).
- Success measured by the number of health care workers trained, upskilled, and employed to be community health care workers (Especialistas) and the number of participant encounters with a trained health care worker [ Time Frame: 1 year ]Curricula will be developed, delivered, and evaluated by the number of health workers trained & employed and the number of encounters between participants & trained health workers (Especialistas). Three modules of training curriculum will be developed for Type 2 Diabetes (T2D) Educators, Researchers, and Care Navigators. Training includes T2D clinical aspects, health determinants, diabetes education for Latinos, technology integration into diabetes education, focused diabetes education, research fundamentals, Good Clinical Practice, human subjects protections, participant recruitment, selection & enrollment, clinical data collection, qualitative data collection methods, technology to enhance & facilitate diabetes research, health care sequence, diabetes resources, social and health care resources, health insurance coverage & eligibility, making referrals to resources, sociocultural insight to diabetes care navigation, and technology facilitate access to resources.
Biospecimen Retention: Samples With DNA
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): NCT03736486
|United States, California|
|Sansum Diabetes Research Institute|
|Santa Barbara, California, United States, 93105|
|Principal Investigator:||David Kerr, M.D.||Sansum Diabetes Research Institute|