Community-based intervention for managing hypertension, diabetes, and smoking in Pokhara, Nepal

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

This study tests a community program in Pokhara, Nepal, that uses home visits and text messages to help adults lower their blood pressure, manage diabetes, and quit smoking.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2070 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Johns Hopkins Bloomberg School of Public Health (other)
• Locations: 1 site (Pokhara, Gandaki)
• Trial ID: NCT06740708 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a multifaceted community-based intervention aimed at reducing hypertension, lowering fasting blood glucose, and increasing smoking cessation rates among adults in Pokhara, Nepal. The intervention involves home visits by female community health volunteers (FCHVs) who provide screening and lifestyle counseling, complemented by regular SMS messages focused on health management. The study employs a cluster randomized controlled trial design, randomizing wards in Pokhara into intervention and control groups to assess the effectiveness of this approach in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 40-75 living in Pokhara who have hypertension, type 2 diabetes, or are current smokers.

Not a fit: Patients with severe hypertension or diabetes, or those with acute symptoms requiring hospitalization, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve health outcomes for individuals with hypertension, type 2 diabetes, and smoking habits in low-resource settings.

How similar studies have performed: Previous studies have shown that community health worker interventions can effectively manage non-communicable diseases, but this approach is novel in its multifaceted implementation in an urban setting.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Registered on the voter list in Pokhara.
3. Not planning to migrate outside of Pokhara during the study period

Exclusion Criteria:

1. Blood pressure ≥180/120 mmHg or
2. Blood glucose \>250 mg/dL or \<54 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

Where this trial is running

Pokhara, Gandaki

• Pokhara Metropolitan City — Pokhara, Gandaki, Nepal (RECRUITING)

Study contacts

• Principal investigator: Dinesh Neupane, PhD — Johns Hopkins University
• Study coordinator: Dinesh Neupane, PhD

Conditions: Hypertension, Type 2 Diabetes Mellitus, Tobacco Smoking, hypertension, type 2 diabetes mellitus, tobacco smoking, task-sharing, task-shifting