Mil Familias- Santa Barbara Operational Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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.
- •Life expectancy < 2 years.
- •Any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation of the trial.
- •Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of study activities and informed consent.
- •Participation in other trials involving medication or device within 1 month prior to Visit
- •Known or suspected abuse of alcohol, narcotics, or illicit drugs.
结局指标
主要结局
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
时间窗: 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 \[Short Assessment of Health Literacy, Trust in Physician, Health Leads Screening Toolkit, and U.S. Household Food Security Survey\].
次要结局
- 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(Beginning of study - Baseline visit 1)
- 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(Beginning of study - Baseline visit 1)
- Support for diabetes care measured by questionnaire adapted from the American Diabetes Association Participant Self-Assessment of Diabetes Management questionnaire(Beginning of study - Baseline visit 1)
- Quality of life measured by the Short Form Health Survey (SF-12)(Day 1 of Visit 3)
- Trust in physician measured by the Trust in Physician (TPS) questionnaire(Day 1 of Visit 3)
- Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview and electronic medical records(Day 1 of Visit 2)
- 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(Day 1 of Visit 2)
- Food security assessed by U.S. Household Food Security Survey Module: Six-item short form(Beginning of study - Baseline visit 1)
- Social needs screening assessed by the Health Leads Screening Toolkit(Beginning of study - Baseline visit 1)
- 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(Day 1 of Visit 2)
- Microalbumin, creatinine, and microalbumin/creatinine ratio measured in a urine sample(Day 1 of Visit 2)
- Depression measured by the Patient Health Questionnaire-9(Day 1 of Visit 2)
- Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20(Day 1 of Visit 2)
- Physical activity measured by two wearable physical activity monitors for 1 week(1 week)
- Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV)(Day 1 of Visit 3)
- Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ)(Day 1 of Visit 3)
- Self-assessment of diabetes management measured by the American Diabetes Association questionnaire, Participant Self-Assessment of Diabetes Management(Beginning of study - Baseline visit 1)
- 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?(Beginning of study - Baseline visit 1)
- Medical history, family medical history, and medication status and history assessed by interview and electronic medical records(Day 1 of Visit 2)
- Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)(Day 1 of Visit 3)
- Health literacy measured by the Short Assessment of Health Literacy (SAHL)(Day 1 of Visit 3)
- Stress measured by the 4 item Perceived Stress Scale (PSS)(Day 1 of Visit 3)