Clinical trial NCT03736486: Mil Familias-Santa Barbara's Operational Pilot to Understand Diabetes in the Latino Community
Official title: Mil Familias- Santa Barbara Operational Pilot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes Mellitus
Cardiovascular Diseases
Keywords: Type 2 diabetes
Cardio-metabolic disease
Latino
Hispanic
Especialista
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2018-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: Beginning of study - Baseline visit 1
measure: Self-assessment of diabetes management measured by the American Diabetes Association questionnaire, Participant Self-Assessment of Diabetes Management
timeFrame: Beginning of study - Baseline visit 1
measure: Food security assessed by U.S. Household Food Security Survey Module: Six-item short form
timeFrame: Beginning of study - Baseline visit 1
measure: Social needs screening assessed by the Health Leads Screening Toolkit
timeFrame: Beginning of study - Baseline visit 1
measure: 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
timeFrame: Beginning of study - Baseline visit 1
measure: 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?
timeFrame: Beginning of study - Baseline visit 1
measure: Support for diabetes care measured by questionnaire adapted from the American Diabetes Association Participant Self-Assessment of Diabetes Management questionnaire
timeFrame: Beginning of study - Baseline visit 1
measure: Medical history, family medical history, and medication status and history assessed by interview and electronic medical records
timeFrame: Day 1 of Visit 2
measure: Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview and electronic medical records
timeFrame: Day 1 of Visit 2
measure: 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
timeFrame: Day 1 of Visit 2
measure: 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
timeFrame: Day 1 of Visit 2
measure: Microalbumin, creatinine, and microalbumin/creatinine ratio measured in a urine sample
timeFrame: Day 1 of Visit 2
measure: Depression measured by the Patient Health Questionnaire-9
timeFrame: Day 1 of Visit 2
measure: Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20
timeFrame: Day 1 of Visit 2
measure: Physical activity measured by two wearable physical activity monitors for 1 week
timeFrame: 1 week
measure: Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)
timeFrame: Day 1 of Visit 3
measure: Health literacy measured by the Short Assessment of Health Literacy (SAHL)
timeFrame: Day 1 of Visit 3
measure: Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV)
timeFrame: Day 1 of Visit 3
measure: Stress measured by the 4 item Perceived Stress Scale (PSS)
timeFrame: Day 1 of Visit 3
measure: Quality of life measured by the Short Form Health Survey (SF-12)
timeFrame: Day 1 of Visit 3
measure: Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ)
timeFrame: Day 1 of Visit 3
measure: Trust in physician measured by the Trust in Physician (TPS) questionnaire
timeFrame: Day 1 of Visit 3
Other outcomes:
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 1 year
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Sansum Diabetes Research Institute
name: David Kerr, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glantz NM, Morales JM, Bevier WC, Larez A, Hoppe CB, Duncan I, Mackenzie A, Kerr D. Insurance Status and Biological and Psychosocial Determinants of Cardiometabolic Risk Among Mexican-Origin U.S. Hispanic/Latino Adults with Type 2 Diabetes. Health Equity. 2020 May 4;4(1):142-149. doi: 10.1089/heq.2019.0119. eCollection 2020.
citation: Bevier W, Glantz N, Hoppe C, Morales Glass J, Larez A, Chen K, Kerr D. Self-reported and objectively measured physical activity levels among Hispanic/Latino adults with type 2 diabetes. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e000893. doi: 10.1136/bmjdrc-2019-000893.