Community Based Health Education to Manage Uncontrolled Blood Pressure in Surkhet, Nepal

September 2, 2017 updated by: Dr. Mahesh Kumar Khanal, Bheri Zonal Ayurveda Hospital

Effectiveness of Community Based Health Education in Reduction of Blood Pressure Among Uncontrolled Hypertensive Patients of Suburban Population of Surkhet District of Nepal

The purpose of the study is to evaluate the effect of health education on blood pressure reduction compared to usual care among uncontrolled hypertensive patients of suburban community of Surkhet district of Nepal.

Study Overview

Detailed Description

Maintenance of normal blood pressure range is necessary to prevent early occurrence of cardiovascular diseases and kidney disease. Adherence of healthy behavior and lifestyle along with medication (if prescribed) are mandatory for effective management of hypertension. Although knowledge and motivation is required for such adherence through health education to the patients,however, no studies has been conducted in Nepal in community setting. Thus, our study will evaluate the effect of health education on blood pressure reduction in community settings.

Method: Cluster randomized trial will be conducted in Birendranagar Municipality of Surkhet District of Nepal. Wards will be clusters where only four ward will be selected randomly among 12 wards wards. Screening program will be conducted for uncontrolled hypertensive patients by visiting every household in systematic manner. Total 36 eligible participants will be enrolled from each cluster who meet the inclusive criteria and provide consent. Then, two clusters will be assigned to for intervention by using simple randomization procedure. Uncontrolled hypertensive patients from rest of two clusters will be the control group who will get usual care by their physician. Four sessions of hypertension related health education will be provided by medical officer and/or registered nurse to intervention group within six months. Trained female health volunteer will visit the participant's home twice a month and will record their blood pressure, motivate the patient and their family members to adhere on healthy behavior and medicine. Follow up data collection will be done after six months. Paired t- test (continues variable) and Chi-square test (binary variable) will be used to test the significance for baseline and after six months for both intervention and control group. Similarly, independent t test (continuous variable) and Chi-square test (binary variable) will be used to test the difference between the groups. Multiple logistic regression analysis will be conducted to evaluate the effect of intervention with and without adjusting confounders.

Expected Results: Primary outcome of the study will be proportion of normalized systolic blood pressure in both the groups. The study will determine the effect of intervention on the between-group difference in the proportion of patients with normalized systolic blood pressure.

Conclusion: The study will be useful to evaluate the effectiveness of health education in community setting. Thus the study will be useful for planning and implementing health education in community to control blood pressure.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Birendranagar Municipality
      • Surkhet, Birendranagar Municipality, Nepal
        • Bheri Zonal Ayurveda Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Who is willing to participate and give consent for the study
  • Uncontrolled hypertension (SBP≥140 mmHg and/or DBP≥90mmHg) including those on antihypertensive medication
  • Can understand Nepali language
  • Capable of effective oral communication
  • Who has telephone or mobile number -

Exclusion Criteria:

  • Dementia and other mental illness
  • Bed ridden patients
  • Known kidney disease, cancer, heart problem, chronic obstructive pulmonary disease
  • Pregnant women
  • Participant who is either blind or deaf

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Health education with support by trained female health volunteer
Along with usual care four sessions of interactive health education will be provided to the participants by medical officer and/or registered nurse based on a syllabus for six months. Trained female female health volunteer will motivate the participants through their home visit twice a month where they will monitor blood pressure and counsel the family members to support the patient.
No Intervention: Control
Extra intervention will not be provided except usual care by their physician of the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with normalized systolic blood pressure of less than 140 mm Hg
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patient with normal diastolic blood pressure less than 90 mm Hg
Time Frame: six months
six months
Change in mean systolic and diastolic blood pressure
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mahesh Kumar Khanal, MPhil, Bheri Zonal Ayurveda Hospital
  • Study Director: Raja Ram Dhungana, MPhil, Nepal Public Health Foundation
  • Study Chair: Yadav Gurung, MPH, Nepal Family Development Foundation
  • Study Chair: Pratiksha Bhandari, MA, Mid Western Regional Hospital
  • Study Chair: K.N. Poudel, MD, Surkhet Hospital Pvt. Lmt.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not decided yet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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