Scaling Up Community-based Noncommunicable Disease Research Into Practice in Pokhara Metropolitan City of Nepal
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 2,070
- Locations
- 1
- Primary Endpoint
- Systolic blood pressure (mmHg)
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: SCALE-NCD (Behavioral)
Control
Control arm will receive the usual care in Pokhara Metropolitan City in Nepal.
Outcomes
Primary Outcomes
Systolic blood pressure (mmHg)
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)