Comprehensive Approach to Hypertension Management in Nepal
- Conditions
- Hypertension
- Interventions
- Behavioral: Comprehensive approach to hypertension management
- Registration Number
- NCT05292469
- Lead Sponsor
- Norwegian University of Science and Technology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1250
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm Comprehensive approach to hypertension management 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.
- Primary Outcome Measures
Name Time Method Mean systolic blood pressure (BP) (mmHg) 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 Outcome Measures
Name Time Method Mean diastolic BP (mmHg) Measured at baseline and follow up between 7 to 8 months after baseline Net change in mean diastolic BP from baseline to follow up
Proportion controlling BP (<140/90 mmHg) 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
Waist Circumference (cm) 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
Body weight (Kg) Measured at baseline and follow up between 7 to 8 months after baseline The mean difference in weight measured at baseline and follow up
Diet low in cholesterol, high in fruits and vegetables 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
Hypertension Knowledge Score 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
Daily salt intake (<1 teaspoon per day) 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
Medication adherence 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
Physical activity 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
Perceived Social Support Scale 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
Maintaining BP logs 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
Trial Locations
- Locations (1)
Institute for Implementation Sciences and Health
🇳🇵Kathmandu, Nepal