Scaling Up Community-based Noncommunicable Disease Research Into Practice in Pokhara Metropolitan City of Nepal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,070
- 试验地点
- 1
- 主要终点
- Systolic blood pressure (mmHg)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a multifaceted community-based intervention, comprising 1) screening and lifestyle counseling by female community health volunteers (FCHVs); community health workers in Nepal, through home visits, and 2) regular Short Message Service (SMS) messages, can effectively reduce systolic blood pressure (SBP), lower fasting blood glucose, and increase smoking cessation rates among adults living in Pokhara with hypertension, type 2 diabetes, and smoking habits, respectively.
The main research questions are:
- Can FCHV home visits combined with regular mobile phone messages focused on blood pressure management reduce systolic blood pressure in adults with hypertension?
- Can FCHV home visits combined with regular mobile phone messages focused on diabetes management lower fasting blood glucose levels in adults with type 2 diabetes?
- Can FCHV home visits combined with regular mobile phone messages focused on smoking cessation increase the cessation rate among current smokers?
Researchers will compare the intervention group with a usual care group, which does not receive regular FCHV home visits for managing the three aforementioned risk factors or mobile phone messages.
详细描述
Background: Rapid globalization and urbanization continue to escalate the burden of non-communicable diseases (NCDs) across the world, disproportionally affecting low- and middle-income countries (LMICs). To date, trials have documented that task-sharing with community health workers (CHWs) can reduce systolic blood pressure and fasting blood glucose and achieve smoking cessation. However, most trials have been done in rural settings, and only focused on managing a single condition, such as hypertension. Furthermore, despite increasing evidence of the effectiveness from clinical trials, there is a lack of studies exploring best practices for 'how' to implement and sustain these interventions in LMICs.
Study Design: Type 2 hybrid effectiveness-implementation research study containing 1) a qualitative study, 2) open-label, two-armed, cluster randomized controlled trial (cRCT), and 3) implementation research plan. The details of the c-RCT only are presented below.
Settings: Pokhara Metropolitan City of Nepal. Pokhara is the second largest city in Nepal containing 33 administrative units called "wards". The investigators consider wards as clusters and randomize these 30 clusters (28 independent wards and 2 combined wards) into intervention and control groups in a 1:1 ratio.
Participants: Adults with ages between 40-75 having at least one of the following conditions:
- Hypertension, defined as:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting at least one of the following three conditions
- •Hypertensive, defined as
- •BP≥140/90 mmHg at two separate measurements
- •Type 2 diabetes, defined as
- •Fingerprick glucose≥100 mg/dL, and plasma fasting glucose ≥126 mg/dL, and HbA1c≥6.5
- •Current smoker, defined as
- •Ever smoked ≥100 cigarettes in lifetime, and
- •Currently smokes every day.
- •Registered on the voter list in Pokhara.
- •Not planning to migrate outside of Pokhara during the study period
排除标准
- •Blood pressure ≥180/120 mmHg or
- •Blood glucose >250 mg/dL or <54 mg/dL
- •Diagnosed with secondary hypertension by health professionals
- •Diagnosed with other diabetes besides type 2 by health professionals
- •Presenting with acute symptoms that may require hospitalizations, which includes but not limited to:
- •Nausea, vomiting, diarrhea
- •Abdominal pain
- •Polyuria, polydipsia, polyphagia
- •Loss of motor or sensory function
- •Altered mental status.
- •Chest pain, chest tightness
- •Dyspnea, shortness of breath
- •Diagnosed as terminally ill by a health professional, defined as life expectancy of 6 months or less.
- •Pregnant or intend to be pregnant
研究组 & 干预措施
SCALE-NCD (Intervention)
Intervention arm will receive the following two components of the SCALE-NCD intervention package:
- FCHV home visits every three months, including measurements, counseling and referral;
- Mobile phone messages, including lifestyle modification
干预措施: SCALE-NCD (Behavioral)
Control
Control arm will receive the usual care in Pokhara Metropolitan City in Nepal.
结局指标
主要结局
Systolic blood pressure (mmHg)
时间窗: 6 months post randomization
Difference in systolic blood pressure change between the intervention and the control groups among participants enrolled as having hypertension.
Fasting Plasma glucose
时间窗: 6 months post randomization
Difference in fasting plasma glucose change between the intervention and the control groups among participants enrolled as having type 2 diabetes.
Participants Who Have Achieved Smoking cessation
时间窗: 6 months post randomization
Participants who have not smoked for the past 30 days between the intervention and the control groups, among participants enrolled as current smokers.
次要结局
- Diastolic blood pressure (mmHg)(6 months post randomization)
- Controlled blood pressure control (<140/90 mmHg) rate(6 months post randomization)
- Mean HbA1c level(6 months post randomization)
- Mean Weight in Kg(6 months post randomization)
- Mean Total Cholesterol (mg/dL)(6 months post randomization)
- Mean HDL (mg/dL)(6 months post randomization)
- Mean LDL level (mg/dL)(6 months post randomization)
- Mean Triglyceride Levels (mg/dL)(6 months post randomization)
- Medication adherence, antihypertensive medicines(6 months post randomization)
- Medication adherence, hypoglycemic medicines(6 months post randomization)
- Harmful alcohol consumption rate, self-report(6 months post randomization)
- Fagerstrom Test for Nicotine Dependence (FTND) score(6 months post randomization)
- Smoking cessation, 7 days(6 months post randomization)
- Low dietary salt intake rate, self-report(6 months post randomization)
- High physical activity rate, self-report(6 months post randomization)
- High fruit and vegetable intake rate, self-report(6 months post randomization)