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Completed

NCT Number: NCT05292469

Comprehensive Approach to Hypertension Management in Nepal

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Implementation Sciences and Health

Kathmandu, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Mean systolic blood pressure (BP) (mmHg)

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

    Net change in mean systolic BP from baseline to follow up

Secondary outcomes

  1. Mean diastolic BP (mmHg)

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

    Net change in mean diastolic BP from baseline to follow up

  2. Proportion controlling BP (<140/90 mmHg)

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

    Proportion of participants controlling BP (<140/90 mmHg) from baseline to follow up

  3. Waist Circumference (cm)

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

    The mean difference in waist circumference measured at baseline and follow up

  4. Body weight (Kg)

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

    The mean difference in weight measured at baseline and follow up

  5. Diet low in cholesterol, high in fruits and vegetables

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

    The proportion consuming diet low in cholesterol, high in fruits and vegetables in the last 24 hours self reported at baseline and follow up

  6. Daily salt intake (<1 teaspoon per day)

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

    The proportion consuming less than 1 teaspoon of salt per day self reported at baseline and follow up

  7. Medication adherence

    Time frame: Self reported at baseline and follow up between 7 to 8 months after baseline

    The proportion adhering to prescribed medication in the past two weeks measured at baseline and follow up

  8. Physical activity

    Time frame: Self reported at baseline and follow up between 7 to 8 months after baseline

    The proportion engaged in moderate physical activity (2.5 hours per week) measured at baseline and follow up

  9. Hypertension Knowledge Score

    Time frame: Self reported at baseline and follow up between 7 to 8 months after baseline

    All together 21 hypertension knowledge statement with 12 true false responses and others with multiple responses to create a aggregate score on hypertension Knowledge

  10. Perceived Social Support Scale

    Time frame: Self reported at baseline and follow up between 7 to 8 months after baseline

    Twelve statements on perceived social support with 7 point Likert scale will be used at baseline and endline

  11. Maintaining BP logs

    Time frame: Self reported at follow up between 7 to 8 months after baseline

    Proportion of trial participants maintaining self BP measurement logs asked during follow up

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Institute for Implementation Sciences and Health, Kathmandu, Nepal

Registry information

Official study title

A Cluster Randomized Trial to Evaluate Comprehensive Approach to Hypertension Management in Nepal

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2022
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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