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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
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

Brief Summary:
The Mil Familias Program is a 10-year initiative to reduce the burden of cardio-metabolic disease among Latino families in the Central Coast of California. The Mil Familias Program involves enrolling 1000 Latino families with at least one member in the family having type 2 diabetes, measuring the 5 determinants of human health: genetics, biology, behavior, psychology and environment, training Latino community health workers ("Especialistas") , creating a Living Information (bio)Bank and planning culturally-relevant interventions.

Condition or disease
Type2 Diabetes Mellitus Cardiovascular Diseases

Detailed Description:
The Mil Familias Pilot Study aims to develop, operationalize and refine methods to both recruit and collect data from 100 adult participants pertaining to the 5 determinants of human health: genetics, biology, behavior, psychology and environment. Specially-trained Latino and bilingual community health workers known as "Especialistas" will be used to help gather data and to serve as the participants trustworthy health companion. Over 100 variables of information pertaining to the 5 determinants of human health (as listed above) will be gathered and stored to create a Living Information (bio)Bank particular to Latinos. The ultimate goal of this research is to provide the target population with effective, culturally-relevant interventions that are geared toward population specific needs.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort
Type 2 Diabetes
Male and female adults of Hispanic and/or Latino heritage with an established diagnosis of Type 2 diabetes.



Primary Outcome Measures :
  1. 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].


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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


Other Outcome Measures:
  1. 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).

  2. 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
Serum, Plasma, Buffy coat (white cells)


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
Sampling Method:   Non-Probability Sample
Study Population
Up to 125 individuals may be screened and enrolled with the prediction of 20% screen-fail or dropout and 100 people completing SB1K Phase I.
Criteria

Inclusion criteria:

  1. Males or females ≥ 18 years of age at Visit 1 (screening and enrollment).
  2. Self-reported Hispanic and/or Latino heritage.
  3. Currently residing in Santa Barbara County, California.
  4. Established diagnosis of Type 2 diabetes for at least one year prior to enrollment date.
  5. Signed and dated written informed consent by the date of Visit 1.
  6. Based on the research staff's judgment, subject must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the wearable device portion.

Exclusion Criteria:

  1. Diagnosed severe cardiovascular disease, within the 6 months prior to enrollment Visit 1, defined as: previous stroke; decompensated heart failure New York Heart Association class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty.
  2. Life expectancy < 2 years.
  3. Any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation of the trial.
  4. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of study activities and informed consent.
  5. Participation in other trials involving medication or device within 1 month prior to Visit 1.
  6. Known or suspected abuse of alcohol, narcotics, or illicit drugs.

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): NCT03736486


Locations
United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Sansum Diabetes Research Institute
Eli Lilly and Company
Investigators
Principal Investigator: David Kerr, M.D. Sansum Diabetes Research Institute

Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT03736486     History of Changes
Other Study ID Numbers: 2017-5864
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) that underlie results in publications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will be made available after the primary publication of each analysis.
Access Criteria: Data Sharing Agreements will be formulated by a committee of study investigators and community and industry partners.
URL: http://www.milfamilias.com

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sansum Diabetes Research Institute:
Type 2 diabetes
Cardio-metabolic disease
Latino
Hispanic
Especialista

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases