HypertensionNCT02981251
Community Based Health Education to Manage Uncontrolled Blood Pressure in Surkhet, Nepal
A study testing Health education with support by trained female health volunteer in people with Hypertension, run by Bheri Zonal Ayurveda Hospital at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Health education with support by trained female health volunteer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteNepal
- Study dates
- Jan 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Health education with support by trained female health volunteer
- Keywords
- Hypertension, Uncontrolled blood pressure, Health education, Community based
- Medical subject headings
- Hypertension, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education with support by trained female health volunteerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Health education with support by trained female health volunteer Receives: Behavioral: Health education with support by trained female health volunteer |
| Control | No intervention | Extra intervention will not be provided except usual care by their physician of the participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with normalized systolic blood pressure of less than 140 mm Hg
Measured: six months
Secondary outcomes (2)
Proportion of patient with normal diastolic blood pressure less than 90 mm Hg
Measured: six months
Change in mean systolic and diastolic blood pressure
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bheri Zonal Ayurveda Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Mahesh Kumar Khanal, Bheri Zonal Ayurveda Hospital
- Investigators
- Mahesh Kumar Khanal, MPhil, Principal investigator, Bheri Zonal Ayurveda HospitalRaja Ram Dhungana, MPhil, Study director, Nepal Public Health FoundationYadav Gurung, MPH, Study chair, Nepal Family Development FoundationPratiksha Bhandari, MA, Study chair, Mid Western Regional HospitalK.N. Poudel, MD, Study chair, Surkhet Hospital Pvt. Lmt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981251
- Sponsor's protocol ID
- 24/2016
- Status last verified
- Aug 2017
- First submitted
- 30 Nov 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Not decided yet
Publications
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.
PubMed 34637478Khanal 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.
PubMed 28982159
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02981251
- Acronym / sponsor ID
- 24/2016
- Conditions
- Hypertension
- Keywords
- Hypertension, Uncontrolled blood pressure, Health education, Community based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Bheri Zonal Ayurveda HospitalOther government
- Study start
- Jan 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health education with support by trained female health volunteerHealth education with support by trained female health volunteer |
| Control | No intervention | –Extra intervention will not be provided except usual care by their physician of the participant. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education with support by trained female health volunteerAlong 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. | Behavioural | Intervention |
Primary outcome
Proportion of patients with normalized systolic blood pressure of less than 140 mm Hg
Time frame: six months
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Derived from this study: PubMed 34637478Khanal 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.
- Derived from this study: PubMed 28982159Khanal 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.
- Individual participant dataSharing planned: Undecided. Not decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahesh Kumar Khanal, MPhil principal investigator
Bheri Zonal Ayurveda Hospital
Raja Ram Dhungana, MPhil study director
Nepal Public Health Foundation
Yadav Gurung, MPH study chair
Nepal Family Development Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education with support by trained female health volunteer in people with Hypertension, run by Bheri Zonal Ayurveda Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with normalized systolic blood pressure of less than 140 mm Hg (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02981251, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.