Clinical trial NCT06740708: Scaling Up Community-based Noncommunicable Disease Research Into Practice in Pokhara Metropolitan City of Nepal
Official title: Scaling Up Community-based Noncommunicable Disease Research Into Practice in Pokhara Metropolitan City of Nepal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Type 2 Diabetes Mellitus (T2DM)
Tobacco Smoking
Keywords: hypertension
type 2 diabetes mellitus
tobacco smoking
task-sharing
task-shifting
community health workers
female community health volunteers
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-12-18
Enrollment: 2070
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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:

  i. BP≥140/90 mmHg at two separate measures, or ii. Under pharmacotherapy for hypertension
* Type 2 diabetes mellitus, defined as i. Fingerprick glucose (fasting) ≥100 mg/dl, plasma glucose (fasting) ≥126 mg/dL, and ii. HbA1c ≥ 6.5 %, or iii. Under pharmacotherapies for type 2 diabetes
* Current tobacco smoking, defined as i. Ever smoked ≥100 cigarettes in lifetime, and ii. Currently smokes every day or on some days.

Intervention: Multifaceted intervention containing the following two components:

1. FCHV home visits every three months
2. Mobile phone messages, including

Control: Usual care in Pokhara Metropolitan City in Nepal, which does not include FCHV home visits for management of hypertension, diabetes, or smoking, and mobile phone messages.

Outcome: Changes in systolic blood pressure, fasting blood glucose, and smoking cessation at 6 months post randomization will be measured as primary outcomes.

Eligibility criteria: Inclusion Criteria:

1. Meeting at least one of the following three conditions

   * Hypertensive, as defined as
   * BP≥140/90 mmHg at two separate measurements, or
   * Under pharmacotherapies for hypertension
   * Type 2 diabetes, as defined as
   * Fingerprick glucose≥100 mg/dL, and plasma fasting glucose ≥126 mg/dL, and HbA1c≥6.5, or
   * Under pharmacotherapies for type 2 diabetes
   * Current smoker, as defined as
   * Ever smoked ≥100 cigarettes in lifetime, and
   * Currently smokes every day or on some days.
2. Registered on the voter list in Pokhara.
3. Not plan to migrate outside of Pokhara during the study period

Exclusion Criteria:

1. Blood pressure ≥180/120 mmHg or \< 90/60 mmHg
2. Blood glucose \>600 mg/dL or \<70 mg/dL
3. Diagnosed with secondary hypertension by health professionals
4. Diagnosed with other diabetes besides type 2 by health professionals
5. 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
   * Fever
6. Diagnosed as terminally ill by a health professional, defined as life expectancy of 6 months or less.
7. Pregnant or intend to be pregnant

Primary outcomes:
measure: Systolic blood pressure (mmHg)
timeFrame: 6 months post randomization
measure: Fasting Plasma glucose
timeFrame: 6 months post randomization
measure: Participants Who Have Achieved Smoking cessation
timeFrame: 6 months post randomization
Secondary outcomes:
measure: Diastolic blood pressure (mmHg)
timeFrame: 6 months post randomization
measure: Controlled blood pressure control (<140/90 mmHg) rate
timeFrame: 6 months post randomization
measure: Mean HbA1c level
timeFrame: 6 months post randomization
measure: Mean Weight in Kg
timeFrame: 6 months post randomization
measure: Mean Total Cholesterol (mg/dL)
timeFrame: 6 months post randomization
measure: Mean HDL (mg/dL)
timeFrame: 6 months post randomization
measure: Mean LDL level (mg/dL)
timeFrame: 6 months post randomization
measure: Mean Triglyceride Levels (mg/dL)
timeFrame: 6 months post randomization
measure: Medication adherence, antihypertensive medicines
timeFrame: 6 months post randomization
measure: Medication adherence, hypoglycemic medicines
timeFrame: 6 months post randomization
measure: Fagerstrom Test for Nicotine Dependence (FTND) score
timeFrame: 6 months post randomization
measure: Smoking cessation, 7 days
timeFrame: 6 months post randomization
measure: Harmful alcohol consumption rate, self-report
timeFrame: 6 months post randomization
measure: Low dietary salt intake rate, self-report
timeFrame: 6 months post randomization
measure: High physical activity rate, self-report
timeFrame: 6 months post randomization
measure: High fruit and vegetable intake rate, self-report
timeFrame: 6 months post randomization
Other outcomes:
Locations:
city: Pokhara
country: Nepal
facility: Pokhara Metropolitan City
state: Gandaki
Study officials:
affiliation: Johns Hopkins University
name: Dinesh Neupane, PhD
role: PRINCIPAL_INVESTIGATOR
References: