跳至主要内容
临床试验/NCT06607341
NCT06607341进行中(未招募)不适用

Community Engagement ALliance Against Disparities - Washington District of Columbia (DC), Maryland, and Virginia (CEAL-DMV)

Johns Hopkins University4 个研究点 分布在 1 个国家目标入组 664 人开始时间: 2024年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
664
试验地点
4
主要终点
Service utilization as assessed by the number of participants who use referral services

研究概览

简要总结

The Community Engagement Alliance against Disparities - Washington District of Columbia, Maryland, Virginia (CEAL DMV), is a multi-community and multi-university consortium. Through collaboration and shared leadership, the CEAL-DMV the consortium- comprising five institutions: George Washington University, Howard University, Johns Hopkins University, Morgan State University, and the University of Maryland, Baltimore-has established a regional structure for bi-directional community involvement to engender trust and foster communication. Each site builds on thriving community partnerships, which have been instrumental in enhancing trust, community capacity, and readiness to reduce health disparities.

详细描述

The investigators propose to evaluate the effect of a multi-level, community-digital health promotion intervention, compared to delayed control intervention, at improving health and social service utilization, and the prevention and management of hypertension, diabetes, overweight and obesity. The evidence-based intervention is based on substantial evidence supporting the role of Community Health Workers in health promotion and reduction of risks associated with chronic diseases.

Studies have demonstrated community health worker (CHW) intervention success at improving chronic disease risks and management, including for hypertension and diabetes, through support in implementing clinical recommendations, overcoming barriers to lifestyle behavior change, achieving personal goals, and preventing complications. Additionally, there is substantial evidence supporting digital approaches for the prevention and management of cardiometabolic diseases. The proposed intervention and methods also build on almost three years of CEAL DMV collaboration with community partners. At the community level, core activities will focus on capacity building to ensure the trusted community-based organization partners are fully supported in the implementation of community-digital strategies to address hypertension, diabetes, overweight and obesity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-identify as Black or Latino
  • Age 18 years or older
  • Reside in defined geographic area
  • Diagnosis of one or more target conditions: Prediabetes/Diabetes (HbA1c 5.7%), Hypertension (≥130/80 mm Hg), Overweight/obesity (BMI >25 kg/m^2)

排除标准

  • Unable to provide informed consent
  • No access to phone/internet

研究组 & 干预措施

Multi-level, community-digital health promotion intervention

Experimental

Participants will receive a multi-level, community-digital health promotion intervention.

  1. Community-level: Community Health Workers will assess needs of individuals including through a survey and facilitate access to the Medi digital resource platform.
  2. Individual level: CHW-delivered coaching on behavior-change goals and facilitation to services via the Medi platform. Participants will also receive tailored social media and in person reinforcements and cues to action based on goal attainment
  3. Social network level: Participants will receive tailored recommendations sent via social media on nearby parks, recreational facilities, faith-based ministries, and peer groups to support behavior change goals

干预措施: Multi-level, community-digital health promotion intervention (Behavioral)

Delayed control intervention group

Active Comparator

At the individual level, participants will receive standardized 12-month text message (SMS) campaign. At the community-level, the investigators will equip community-based organization partners and community health workers with chronic disease educational content. Participants will also receive recommendations for health events and fairs locally.

干预措施: Multi-level, community-digital health promotion intervention (Behavioral)

结局指标

主要结局

Service utilization as assessed by the number of participants who use referral services

时间窗: 6 and 9 months

Utilization will be calculated by the total number of participants who use services referred to by the community health workers.

次要结局

  • Satisfaction with health and health-related social services as assessed by a 3-point Likert Scale(6 and 9 months)
  • Body mass index (BMI) in kg/m^2(6 and 9 months)
  • Blood pressure(6 and 9 months)
  • Hemoglobin A1c (HbA1c) levels(6 and 9 months)
  • Trust in health research and information sources as assessed by the Trust in Medical Research Survey(6 and 9 months.)
  • Social determinants of health as assessed by the Health Related Social Needs Tool(6 and 9 months.)
  • Self-reported exercise frequency(6 and 9 months)
  • Self-reported intake of regular soda or pop that contains sugar.(6 and 9 months)
  • Self-reported sweetened fruit drinks intake(6 and 9 months)
  • Self-reported fruit intake(6 and 9 months)
  • Self-reported intake of green leafy or lettuce salad(6 and 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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