Comprehensive Approach to Hypertension Management in Nepal

A Cluster Randomized Trial to Evaluate 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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Comprehensive approach to hypertension management

• Study Type: Interventional
• Enrollment (Estimated): 1250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abhijit Sen, prof; Phone Number: +47 40106033; Email: abhijit.sen@ntnu.no
• Study Contact Backup: Name: Sanju Bhattarai; Phone Number: +977 9851055424; Email: sanjuwagle@gmail.com

Study Locations

• Nepal
  • Kathmandu, Nepal
    • Recruiting
    • Institute for Implementation Sciences and Health
    • Contact: Sanju Bhattarai; Phone Number: +977 9851055424; Email: sanjuwagle@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Routine hypertension care
Experimental: Intervention arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean diastolic BP (mmHg)	Net change in mean diastolic BP from baseline to follow up	Measured at baseline and follow up between 7 to 8 months after baseline
Proportion controlling BP (<140/90 mmHg)	Proportion of participants controlling BP (<140/90 mmHg) from baseline to follow up	Measured at baseline and follow up between 7 to 8 months after baseline
Waist Circumference (cm)	The mean difference in waist circumference measured at baseline and follow up	Measured at baseline and follow up between 7 to 8 months after baseline
Body weight (Kg)	The mean difference in weight measured at baseline and follow up	Measured at baseline and follow up between 7 to 8 months after baseline
Diet low in cholesterol, high in fruits and vegetables	The proportion consuming diet low in cholesterol, high in fruits and vegetables in the last 24 hours self reported at baseline and follow up	Reported at baseline and follow up between 7 to 8 months after baseline
Daily salt intake (<1 teaspoon per day)	The proportion consuming less than 1 teaspoon of salt per day self reported at baseline and follow up	Reported at baseline and follow up between 7 to 8 months after baseline
Medication adherence	The proportion adhering to prescribed medication in the past two weeks measured at baseline and follow up	Self reported at baseline and follow up between 7 to 8 months after baseline
Physical activity	The proportion engaged in moderate physical activity (2.5 hours per week) measured at baseline and follow up	Self reported at baseline and follow up between 7 to 8 months after baseline
Hypertension Knowledge Score	All together 21 hypertension knowledge statement with 12 true false responses and others with multiple responses to create a aggregate score on hypertension Knowledge	Self reported at baseline and follow up between 7 to 8 months after baseline
Perceived Social Support Scale	Twelve statements on perceived social support with 7 point Likert scale will be used at baseline and endline	Self reported at baseline and follow up between 7 to 8 months after baseline
Maintaining BP logs	Proportion of trial participants maintaining self BP measurement logs asked during follow up	Self reported at follow up between 7 to 8 months after baseline

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Institute for Implementation Sciences and Health, Kathmandu, Nepal
• Investigators: Study Director: Solveig Kirsti Grudt, Norwegian University of Science and Technology; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Monitoring; Nepal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 399476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No