An interventional study of Health education with support by trained female health volunteer in Hypertension, sponsored by Bheri Zonal Ayurveda Hospital. Completed at 1 site in Nepal. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2017-09-06.
Sponsored by Bheri Zonal Ayurveda Hospital · Not applicable, Interventional, and Prevention
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 142 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →This is the only study on the registry with Bheri Zonal Ayurveda Hospital as lead sponsor.
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Exclusion Criteria:
Health education with support by trained female health volunteer
Behavioral: Health education with support by trained female health volunteer
Extra intervention will not be provided except usual care by their physician of the participant.
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.
Proportion of patients with normalized systolic blood pressure of less than 140 mm Hg
Time frame: six months
Proportion of patient with normal diastolic blood pressure less than 90 mm Hg
Time frame: six months
Change in mean systolic and diastolic blood pressure
Time frame: six months
Plan to share: Undecided — Not decided yet
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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