Conquering Hypertension in Urban Vietnam
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Systolic blood pressure level
研究概览
简要总结
The HTN-URBAN project aims to improve hypertension (HTN) control for adults in a large northern Vietnamese city via a cluster-randomized trial design.
详细描述
A Cluster-randomized, Type II Hybrid effectiveness implementation Trial will take place in 14 urban communities in 7 urban districts in Hai Phong city in northern Vietnam.
Community Eligibility Criteria: (1) located in urban Hai Phong city; (2) distance between 2 communities will be at least 10 Km; (3) no other research studies/ health programs currently being implemented; and (4) key community and clinical leaders are willing to participate in the study.
Recruitment
Residents from participating sites will be invited to attend the community screening events run by local community health center (CHC) staff and Community Health Workers (CHWs). Those meeting our pre-defined eligibility criteria will be invited to their CHCs to learn more about the study. Patients with elevated blood pressure (BP) will be invited for re-measurement over the next two weeks (at least 1 week apart). After the second BP measurement, patients with elevated BP will be invited to participate in the study.
Randomization
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years old;
- •Presence of uncontrolled HTN (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg) according to JNC-8;
- •Willing to provide informed consent.
排除标准
- •Participation in another study on hypertension;
- •Pregnant;
- •Advanced cognitive impairment;
- •Previous exposure to storytelling modules;
- •Participant family member;
- •Participant in intervention development.
研究组 & 干预措施
Comparison Group
Patients in the comparison group will receive the "Learn More" module only.
干预措施: "Learn More" module only (Behavioral)
Intervention Group
Patients in the intervention group will receive HTN-URBAN intervention, which includes three integrated components:
(1) Storytelling intervention, (2) Home BP monitoring, (3) Expanded community health worker services.
干预措施: Storytelling intervention (Behavioral)
Intervention Group
Patients in the intervention group will receive HTN-URBAN intervention, which includes three integrated components:
(1) Storytelling intervention, (2) Home BP monitoring, (3) Expanded community health worker services.
干预措施: Home BP monitoring (Behavioral)
Intervention Group
Patients in the intervention group will receive HTN-URBAN intervention, which includes three integrated components:
(1) Storytelling intervention, (2) Home BP monitoring, (3) Expanded community health worker services.
干预措施: Expanded community health worker services (Behavioral)
结局指标
主要结局
Systolic blood pressure level
时间窗: From baseline to 3, 6 and 12 month follow up visits
Changes in systolic blood pressure levels
Acceptability, Appropriateness, Feasibility
时间窗: at 3, 6, and 12 month follow-up visits
Information will be collected via semi-structured interviews among patients, Community health workers, community leaders, and local clinicians and nurses mentioned previously and patient interviews and post-story viewing surveys.
Adoption
时间窗: at baseline, 3, 6, and 12 month follow-up visits
Data for participant recruitment and retention will include the number of patients approached for recruitment, reasons for ineligibility of patients not enrolled or refusing to participate, and completion rates for follow-up visits.
Fidelity
时间窗: at 3, 6, and 12 month follow-up visits
Information will be collected via periodic random observations of blood pressure measurement and patient interviews by study investigators and the project manager who will document and check intervention deliverables using a standardized checklist.
次要结局
- Cost(at 12 month follow up)
- Diastolic blood pressure level(From baseline to 3, 6 and 12 months)
- Hypertension control(From 3 to 6 and12 months follow up visits)
- Self-efficacy(From baseline to follow-up at 3, 6, and 12 months)
- Hypertension (HTN) medication adherance(From baseline to 3, 6, and 12 month follow-up visits)
- Risk of cardiovascular disease (CVD)(From baseline to follow-up at 12 months)
- Patient quality of life(From baseline to 3, 6 and 12 month follow up visits)
研究者
Hoa Nguyen
Professor
University of Massachusetts, Worcester