Clinical trial NCT05292469: Comprehensive Approach to Hypertension Management in Nepal
Official title: A Cluster Randomized Trial to Evaluate Comprehensive Approach to Hypertension Management in Nepal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Nepal
Monitoring
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Institute for Implementation Sciences and Health, Kathmandu, Nepal
First posted: 2022-03-23
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mean systolic blood pressure (BP) (mmHg)
timeFrame: Measured at baseline and follow up between 7 to 8 months after baseline
Secondary outcomes:
measure: Mean diastolic BP (mmHg)
timeFrame: Measured at baseline and follow up between 7 to 8 months after baseline
measure: Proportion controlling BP (<140/90 mmHg)
timeFrame: Measured at baseline and follow up between 7 to 8 months after baseline
measure: Waist Circumference (cm)
timeFrame: Measured at baseline and follow up between 7 to 8 months after baseline
measure: Body weight (Kg)
timeFrame: Measured at baseline and follow up between 7 to 8 months after baseline
measure: Diet low in cholesterol, high in fruits and vegetables
timeFrame: Reported at baseline and follow up between 7 to 8 months after baseline
measure: Daily salt intake (<1 teaspoon per day)
timeFrame: Reported at baseline and follow up between 7 to 8 months after baseline
measure: Medication adherence
timeFrame: Self reported at baseline and follow up between 7 to 8 months after baseline
measure: Physical activity
timeFrame: Self reported at baseline and follow up between 7 to 8 months after baseline
measure: Hypertension Knowledge Score
timeFrame: Self reported at baseline and follow up between 7 to 8 months after baseline
measure: Perceived Social Support Scale
timeFrame: Self reported at baseline and follow up between 7 to 8 months after baseline
measure: Maintaining BP logs
timeFrame: Self reported at follow up between 7 to 8 months after baseline
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Institute for Implementation Sciences and Health
Study officials:
affiliation: Norwegian University of Science and Technology
name: Solveig Kirsti Grudt
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Abhijit Sen, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Implementation Sciences and Health, Nepal
name: Archana Shrestha
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Implementation Science and Health
name: Sanju Bhattarai
role: PRINCIPAL_INVESTIGATOR
References: