Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-07 @ 1:15 PM
Study NCT ID:
NCT02981251
Status:
COMPLETED
Last Update Posted:
2017-09-06
First Post:
2016-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Based Health Education to Manage Uncontrolled Blood Pressure in Surkhet, Nepal
Sponsor:
Bheri Zonal Ayurveda Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: