Comprehensive Approach to Hypertension Management in Nepal

NCT05292469 | Completed

• 1 other identifier: 399476
• Study Type: interventional
• Target: 1,252
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Nepal; Monitoring

Outcome Measures

Primary Outcomes (1)

• Mean systolic blood pressure (BP) (mmHg)

  Net change in mean systolic BP from baseline to follow up

  Measured at baseline and follow up between 7 to 8 months after baseline

Secondary Outcomes (11)

• Mean diastolic BP (mmHg)

  Measured at baseline and follow up between 7 to 8 months after baseline

• Proportion controlling BP (<140/90 mmHg)

  Measured at baseline and follow up between 7 to 8 months after baseline

• Waist Circumference (cm)

  Measured at baseline and follow up between 7 to 8 months after baseline

• Body weight (Kg)

  Measured at baseline and follow up between 7 to 8 months after baseline

• Diet low in cholesterol, high in fruits and vegetables

  Reported at baseline and follow up between 7 to 8 months after baseline

Study Arms (2)

Control arm

NO INTERVENTION

Routine hypertension care

Intervention arm

EXPERIMENTAL

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.

Behavioral: Comprehensive approach to hypertension management

Interventions

Comprehensive approach to hypertension management BEHAVIORAL

Trained health workers will review blood pressure (BP) logs and provide treatment. The patients will receive a BP lowering informational package, BP monitoring device and log book and pill-box and medication table. The participants will receive monthly home visits (6 visits) to discuss hypertension and ways to manage it. They will be encouraged to identify problems and developing an action plan to solve them. The participants will be encouraged to set behavioral goals. The follow up visits will review the progress made in implementing action plan and goals set and updating them. Review BP logs and facilitate tailored discussion on topics based on problems faced by participants on barriers to medication adherence, physical activity, weight management or diet. The family members will be involved and be accountable in supporting the patients in achieving the action plans.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Institute for Implementation Sciences and Health, Kathmandu, Nepal: collaborator

Study Sites (1)

Institute for Implementation Sciences and Health

Kathmandu, Nepal

Location

Related Publications (4)

• Bhattarai S, Shrestha A, Skovlund E, Asvold BO, Mjolstad BP, Sen A. Cluster randomised trial to evaluate comprehensive approach to hypertension management in Nepal: a study protocol. BMJ Open. 2023 May 11;13(5):e069898. doi: 10.1136/bmjopen-2022-069898.

  PMID: 37169495 BACKGROUND

• Bhattarai S, Wagle D, Shrestha A, Asvold BO, Skovlund E, Sen A. Role of Perceived Social Support in Adherence to Antihypertensives and Controlled Hypertension: Findings of a Community Survey from Urban Nepal. Patient Prefer Adherence. 2024 Mar 26;18:767-777. doi: 10.2147/PPA.S455511. eCollection 2024.

  PMID: 38558834 BACKGROUND

• Bhattarai S, Skovlund E, Shrestha A, Mjolstad BP, Asvold BO, Sen A. Impact of a community health worker led intervention for improved blood pressure control in urban Nepal: an open-label cluster randomised controlled trial. Lancet Reg Health Southeast Asia. 2024 Aug 8;29:100461. doi: 10.1016/j.lansea.2024.100461. eCollection 2024 Oct.

  PMID: 39220804 BACKGROUND

• Bhattarai S, Bajracharya S, Shrestha A, Skovlund E, Asvold BO, Mjolstad BP, Sen A. Facilitators and barriers to hypertension management in urban Nepal: findings from a qualitative study. Open Heart. 2023 Oct;10(2):e002394. doi: 10.1136/openhrt-2023-002394.

  PMID: 37899127 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Solveig Kirsti Grudt

  Norwegian University of Science and Technology

  STUDY DIRECTOR

• Abhijit Sen, prof

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Archana Shrestha

  Institute for Implementation Sciences and Health, Nepal

  PRINCIPAL INVESTIGATOR

• Sanju Bhattarai

  Institute for Implementation Science and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized Trial

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 23, 2022
• Study Start: May 2, 2022
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

NE (1)