Clinical trial NCT02981251: Community Based Health Education to Manage Uncontrolled Blood Pressure in Surkhet, Nepal
Official title: Effectiveness of Community Based Health Education in Reduction of Blood Pressure Among Uncontrolled Hypertensive Patients of Suburban Population of Surkhet District of Nepal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Uncontrolled blood pressure
Health education
Community based
Lead sponsor: Bheri Zonal Ayurveda Hospital
Sponsor class: OTHER_GOV
First posted: 2016-12-05
Enrollment: 142
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with normalized systolic blood pressure of less than 140 mm Hg
timeFrame: six months
Secondary outcomes:
measure: Proportion of patient with normal diastolic blood pressure less than 90 mm Hg
timeFrame: six months
measure: Change in mean systolic and diastolic blood pressure
timeFrame: six months
Other outcomes:
Locations:
city: Surkhet
country: Nepal
facility: Bheri Zonal Ayurveda Hospital
state: Birendranagar Municipality
Study officials:
affiliation: Bheri Zonal Ayurveda Hospital
name: Mahesh Kumar Khanal, MPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Nepal Public Health Foundation
name: Raja Ram Dhungana, MPhil
role: STUDY_DIRECTOR
affiliation: Nepal Family Development Foundation
name: Yadav Gurung, MPH
role: STUDY_CHAIR
affiliation: Mid Western Regional Hospital
name: Pratiksha Bhandari, MA
role: STUDY_CHAIR
affiliation: Surkhet Hospital Pvt. Lmt.
name: K.N. Poudel, MD
role: STUDY_CHAIR
References:
citation: Khanal MK, Bhandari P, Dhungana RR, Bhandari P, Rawal LB, Gurung Y, Paudel KN, Singh A, Devkota S, Courten B. Effectiveness of community-based health education and home support program to reduce blood pressure among patients with uncontrolled hypertension in Nepal: A cluster-randomized trial. PLoS One. 2021 Oct 12;16(10):e0258406. doi: 10.1371/journal.pone.0258406. eCollection 2021.
citation: Khanal MK, Dhungana RR, Bhandari P, Gurung Y, Paudel KN. Prevalence, associated factors, awareness, treatment, and control of hypertension: Findings from a cross sectional study conducted as a part of a community based intervention trial in Surkhet, Mid-western region of Nepal. PLoS One. 2017 Oct 5;12(10):e0185806. doi: 10.1371/journal.pone.0185806. eCollection 2017.