Scaling Up Community-based Noncommunicable Disease Research Into Practice in Pokhara Metropolitan City of Nepal (SCALE NCD)

Johns Hopkins Bloomberg School of Public Health

Status: Enrolling

Conditions: Hypertension; Type 2 Diabetes Mellitus (T2DM); Tobacco Smoking

Treatments: Behavioral: SCALE-NCD

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06740708

IRB00030203

R01HL172271 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,070 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,070 participants in 2 patient groups

SCALE-NCD (Intervention)

Experimental group

Description:

Intervention arm will receive the following two components of the SCALE-NCD intervention package: 1. FCHV home visits every three months, including measurements, counseling and referral; 2. Mobile phone messages, including lifestyle modification

Treatment:

Behavioral: SCALE-NCD

Control

No Intervention group

Description:

Control arm will receive the usual care in Pokhara Metropolitan City in Nepal.