The Role of Community Health Workers to Reduce Health Disparities Using a Multi-Level Integrated Population Health Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Allostatic load
研究概览
简要总结
The primary aim of this study is to determine whether community health worker (CHW) navigation improves outcomes of chronic disease and chronic disease risk factors in a low-income, primarily ethnic minority population when combined with an evidence-based population health model as compared to usual care after 10 months.
详细描述
The I-POP+CHW participants will be paired with a CHW at baseline to assist with navigation for 10-months between health and wellness services in the selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227. Participants will receive a multi-level intervention utilizing the current I-POP Health model that includes: 1) Access to health services (including oral health), 2) Access to clinical prevention services, 3) Access to education and facilities to increase physical activity and improved nutrition choices, and 4) Scheduled visits with CHWs for education and navigation. Individuals will complete study measures at baseline, 6-months, and 10-months.
The control group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months (delayed CHW navigation). The current usual care model is outlined below (section 2.3) Participants will complete study measures at baseline, 6-months, and 10-months timepoints. Upon completion of 10-months measures, these individuals will be assigned a CHW and receive delayed navigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Ability to alter diet and/or physical activity
- •Willing to participate in a 10-month study
- •Resident of selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227
- •Not having utilized BSW HWC membership services within the past 12 months
- •Not planning to move outside of the selected zip code area within the next 6 months
排除标准
- •Below the age of 18 years
- •Unable or unwilling to alter diet and/or physical activity
- •Not willing to participate in a 10-month study
- •Not resident of local selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227
- •Currently using or have used BSW HWC membership services within the past 12 months
- •Planning to move outside of the selected zip code area within the next 6 months
研究组 & 干预措施
Control
Control group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months (delayed CHW navigation). The current usual care model is outlined. Participants will complete study measures at baseline, 6-months, and 10-months timepoints. Upon completion of 10-months measures, these individuals will be assigned a CHW and receive delayed navigation.
干预措施: Usual Care (Other)
I-POP CHW Intervention
I-POP+CHW participants will be paired with a CHW at baseline to assist with navigation for 10-months between health and wellness services in the selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227. Participants will receive a multi-level intervention utilizing the current I-POP Health model that includes: 1) Access to health services (including oral health), 2) Access to clinical prevention services, 3) Access to education and facilities to increase physical activity and improved nutrition choices, and 4) Scheduled visits with CHWs for education and navigation. Individuals will complete study measures at baseline, 6-months, and 10-months.
干预措施: I-POP + CHW navigation (Other)
结局指标
主要结局
Allostatic load
时间窗: 6-months
A composite score of 10 biomarkers to measure chronic stress and health outcomes. The biomarkers are BMI, waist-to-hip ratio, HDL, TC/HDL ratio, triglycerides, HbA1c, SBP, DBP, C-reactive protein, and cortisol. For each marker a value of 1 will be assigned if that exceed the third quartile except for HDL where a value of 1 will be assigned if lower than first quartile; otherwise a score of zero will be assigned. \[scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5\].
Cortisol
时间窗: 6-months
4mL saliva collected fasting in the morning. \[Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.\]
C-Reactive protein
时间窗: 6-months
4mL saliva collected fasting in the morning. \[Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.\]
Body mass index
时间窗: 10-months
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Waist - to - Hip ratio
时间窗: 10-months
Waist circumference (centimeters) divided by circumference of hips (centimeters)
HbA1c
时间窗: 10-months
Finger stick blood measure (%)
Lipids
时间窗: 10-months
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Blood pressure
时间窗: 10-months
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
C-Reactive protein
时间窗: Baseline
4mL saliva collected fasting in the morning. \[Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.\]
Body mass index
时间窗: Baseline
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Body mass index
时间窗: 6-months
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Waist - to - Hip ratio
时间窗: Baseline
Waist circumference (centimeters) divided by circumference of hips (centimeters)
Waist - to - Hip ratio
时间窗: 6-months
Waist circumference (centimeters) divided by circumference of hips (centimeters)
HbA1c
时间窗: Baseline
Finger stick blood measure (%)
HbA1c
时间窗: 6-months
Finger stick blood measure (%)
Lipids
时间窗: Baseline
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Lipids
时间窗: 6-months
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Blood pressure
时间窗: Baseline
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
Blood pressure
时间窗: 6-months
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
Allostatic load
时间窗: Baseline
A composite score of 10 biomarkers to measure chronic stress and health outcomes. The biomarkers are BMI, waist-to-hip ratio, HDL, TC/HDL ratio, triglycerides, HbA1c, SBP, DBP, C-reactive protein, and cortisol. For each marker a value of 1 will be assigned if that exceed the third quartile except for HDL where a value of 1 will be assigned if lower than first quartile; otherwise a score of zero will be assigned. \[scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5\]
Cortisol
时间窗: Baseline
4mL saliva collected fasting in the morning. \[Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.\]
次要结局
- Diet(10-months)
- Physical activity(10-months)
- Services utilization(10-months)
- Social determinants(10-months)
- Perceived stress(10-months)
- Medication use(10-months)
- Social determinants(Baseline)
- Social determinants(6-months)
- Perceived stress(Baseline)
- Perceived stress(6-months)
- Medication use(Baseline)
- Medication use(6-months)
- Diet(Baseline)
- Diet(6-months)
- Physical activity(Baseline)
- Physical activity(6-months)
- Services utilization(Baseline)
- Services utilization(6-months)