Comprehensive Approach to Hypertension Management in Nepal

Norwegian University of Science and Technology

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Comprehensive approach to hypertension management

Study type: Interventional

Funder types: Other

Identifiers

NCT05292469

399476

Details and patient eligibility

About

Hypertension is a global risk factor for cardiovascular diseases. Approximately 80% hypertension burden is in low-and-middle income countries. Hypertension can be managed with antihypertensive medication and following effective lifestyle interventions, however the control rate of hypertension among those on treatment is dismal. In Nepal, a quarter of adult population have hypertension of whom, 44% are unaware of their status, 33% are on treatment, and, only 12% are controlled. A comprehensive intervention strategy for hypertension management has shown promising results in high income countries. Therefore, it is of interest to understand its effectiveness, appropriateness and feasibility in the low income settings such as Nepal. The objective of the trial is to assess the impact on net change in mean systolic blood pressure measured between 7 to 8 months follow-up of a comprehensive intervention which provides personalized counselling on lifestyle modification and medication adherence together with support for regular monitoring of blood pressure at home, compared with a control arm where hypertensive patients have access to routine care only. The investigators are proposing a cluster randomized controlled trial conducted in government health facilities from Budhanilakantha, an urban municipality in the Bagmati Province of Nepal. Trial arms: 1) control (routine hypertension care); 2) Comprehensive approach to hypertension management that includes blood pressure (BP) audit and feedback by physician (nurse and doctor), and patient support to monitor BP, and home based patient care by community health workers to encourage self-monitoring of BP followed by tailored educational counselling on behavioral and lifestyle change. Eligible participants providing consent will be enrolled into the trial by a research assistant who will conduct interviews. Those from the intervention arm will receive the home visits for 6 months. Participants from both arms will provide follow up data in 7 to 8 months.

Enrollment: 1,252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypertension patients (systolic blood pressure 140 mmHg or more and/or diastolic blood pressure 90 mmHg or more on at least two separate visits, or use of antihypertensive medication)
• Living in the area served by the participating health facilities

Exclusion criteria

• Pregnancy
• Not able or willing to give informed consent,
• Critically ill from depilating conditions such as dialysis, cancer, palliative care
• Not likely to continue living in the area served by the health facility during trial follow up period (8 months)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,252 participants in 2 patient groups

Control arm

No Intervention group

Description:

Routine hypertension care

Intervention arm

Experimental group

Description:

Comprehensive approach to hypertension management that includes BP audit and feedback by physician (nurse and doctor), and patient support to monitor BP, and home based patient care by community health workers to encourage self-monitoring of BP followed by tailored educational counselling on behavioral and lifestyle change in addition to routine care.

Treatment:

Behavioral: Comprehensive approach to hypertension management