Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Percentage of Patients Who Achieve Blood Pressure (BP) Control.
研究概览
简要总结
The purpose of this study is to work with primary care physicians and their staff, and with community health workers (CHWs) to improve diabetes and hypertension management, health behaviors and improve blood pressure for South Asian patients with uncontrolled diabetes and hypertension in primary care clinics in Atlanta, Georgia. The CHWs are community members who are trained to work with patients to address health needs holistically by providing information on wellness, nutrition, stress relief, and blood pressure management in a culturally-appropriate and language-appropriate manner.
详细描述
The study will provide research training, technical assistance, and capacity-building to community and clinical sites in Georgia for implementation of culturally tailored, evidenced-based CHW programs to improve HTN and diabetes management for South Asians. In addition, the use a multi-theoretical framework to test the effectiveness of a CHW-led intervention compared to usual care among South Asian individuals with diabetes and uncontrolled HTN in Atlanta. The primary outcome is blood pressure control, defined as 130/80 mmHg. It is hypothesized that, compared to usual care, individuals receiving the CHW intervention will be 20% more likely to achieve blood pressure control at 6 months.
And to apply RE-AIM and CFIR frameworks to delineate factors influencing appropriateness, fidelity, adoption, and maintenance of the intervention within clinical and community settings to optimize intervention replication.
In addition, this study will serve as a national information and dissemination resource in the adaptation of evidence-based strategies to reduce geographic disparities in HTN and diabetes across Asian American groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •identified as of South Asian ethnicity
- •are at least 21 years of age and younger than age 80
- •had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months
- •a diagnosis of diabetes
- •a diagnosis of hypertension
- •an uncontrolled BP reading (>130/80mmHg) in the last 6 months
- •Provider Surveys Inclusion criteria
- •clinicians employed by the clinic
- •have enrolled into the study.
- •Key Informant Interviews Inclusion criteria
- •must be a provider, clinic manager, or community health worker.
- •CHW intervention
排除标准
- •under the age of 21 and older than 80
- •Type 1 diabetes or diabetes secondary to other conditions
- •malignancy or life threatening illness with life expectancy of <5 years
- •inability to perform unsupervised physical activity
- •diagnosed cognitive deficits or limited decision-making capacity
- •Provider Surveys Inclusion criteria
- •clinicians who are unable to complete the survey in the English language.
- •Key Informant Interviews Inclusion criteria
- •who are unable to participate in the interview conducted in the English language.
结局指标
主要结局
Percentage of Patients Who Achieve Blood Pressure (BP) Control.
时间窗: Month 6
The primary outcome will be the percentage of eligible patients at a practice site to achieve BP control (130/80 mmHg) six months following the index office visit. The primary outcome will be measured by the treatment participants and providers surveys.
次要结局
- Change in Haemoglobin A1c (HbA1c)(6 months)
- Systolic Blood Pressure (SBP)(Month 6)
- Diastolic Blood Pressure (DBP)(Month 6)
- Body Mass Index (BMI)(Month 6)