HypertensionCOBINNCT02428075
Community-based Management of Hypertension in Nepal
A study testing FCHV visit in people with Hypertension, run by University of Aarhus at 1 site in Nepal.
Trial summary
Hypertension contributes to significant burden of cardiovascular diseases (CVDs) in low and middle-income countries; however responses to CVDs are inadequate particularly due to lack of conclusive evidence on population based approach to hypertension control. Read more about this study
- Who is it for?
- Ages 25 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- FCHV visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,638 participants
- Where
- 1 siteNepal
- Study dates
- Nov 2015to Feb 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 25 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- People ≥25 years of age and who are listed in the voter list of 2006 and those participated in our prevalence study are eligible for inclusion in the baseline survey. - Person who give consent to participate in our intervention study,
- does not have any plan to migrate from Lekhnath Municipality for at least 1 year,
- non-pregnant women and
- personal who are not severely ill will be included as eligible participants.
Who cannot join
- No consent
- Pregnant women
- Severely Il
- Plan for migration for the study municipality within 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for Community-based Intervention for Blood Pressure Reduction in Nepal: a Community-based Cluster Randomized Controlled Trial
Hypertension contributes to significant burden of cardiovascular diseases (CVDs) in low and middle-income countries; however responses to CVDs are inadequate particularly due to lack of conclusive evidence on population based approach to hypertension control. This is a community based cluster randomized trial involving family based health education through female community health volunteers in Nepal. People ≥25 years of age and who are listed in the voter list 2006 of Electoral Commission of Nepal who were either hypertensive, pre-hypertensive or normotensive are eligible for eligible for participation in the study. A computer generated random codes will be used to divide clusters into treatment and control arm. FCHVs will conduct family based health education and blood pressure measurements in the treatment arm vs not any interventions in control arm. Independent assessors will conduct the baseline and end line assessment of the intervention. Intention to treat analysis and per protocol analysis will be used in analysis to detect significant differences between treatment and control group participants at baseline and follow up. Student t-tests for normally distributed variables and chi-squared tests for categorical variables will be used. In the event that randomization do not control for differences between the treatment and control groups on baseline characteristics, the investigators will statistically control for those differences in subsequent analysis of program effects. The final outcome will be modeled by using multiple linear regressions analysis. The investigators hope that if the intervention outcomes shows positive effects in treatment arm, this approach can be adopted into the existing health care delivery system in Nepal. Assessing the FCHVs' ability may further contribute to developing a policy that can be scaled-up to a national level. The lessons learned from this project may also be replicated in rural areas and similar settings elsewhere in the world.
- Conditions
- Hypertension
- Being tested
- FCHV visit
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCHV visitBehavioural
Also called FCHV Home Visit
Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure
| Study group | Role | What they receive |
|---|---|---|
| FCHV visit-normotensive | Experimental | Not described Receives: Behavioral: FCHV visit |
| FCHV no visit-normotensive | No intervention | Not described |
| FCHV visit-prehypertensive | Experimental | Not described Receives: Behavioral: FCHV visit |
| FCHV no visit-prehypertensive | No intervention | Not described |
| FCHV visit-hypertensive | Experimental | Not described Receives: Behavioral: FCHV visit |
| FCHV no visit-hypertensive | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean systolic blood pressure in normotensive, pre-hypertensive and hypertensive populations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 1,638 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinesh Neupane, University of Aarhus
- Investigators
- Dinesh Neupane, PhD Fellow, Principal investigator, Center for Global Health, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428075
- Sponsor's protocol ID
- Hypertension-Nepal
- Acronym
- COBIN
- Status last verified
- Feb 2017
- First submitted
- 23 Apr 2015
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Paudel S, Subedi N, McLachlan CS, Smith BJ, Kallestrup P, Neupane D. Active commuting and leisure-time physical activity among adults in western Nepal: a cross-sectional study. BMJ Open. 2021 Aug 12;11(8):e051846. doi: 10.1136/bmjopen-2021-051846.
PubMed 34385256Neupane D, McLachlan CS, Mishra SR, Olsen MH, Perry HB, Karki A, Kallestrup P. Effectiveness of a lifestyle intervention led by female community health volunteers versus usual care in blood pressure reduction (COBIN): an open-label, cluster-randomised trial. Lancet Glob Health. 2018 Jan;6(1):e66-e73. doi: 10.1016/S2214-109X(17)30411-4.
PubMed 29241617Neupane D, McLachlan CS, Christensen B, Karki A, Perry HB, Kallestrup P. Community-based intervention for blood pressure reduction in Nepal (COBIN trial): study protocol for a cluster-randomized controlled trial. Trials. 2016 Jun 18;17(1):292. doi: 10.1186/s13063-016-1412-3.
PubMed 27316539
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Community-based Intervention for Blood Pressure Reduction in Nepal: a Community-based Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02428075
- Acronym / sponsor ID
- COBIN / Hypertension-Nepal
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,638 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Apr 2015 (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.
Hypertension contributes to significant burden of cardiovascular diseases (CVDs) in low and middle-income countries; however responses to CVDs are inadequate particularly due to lack of conclusive evidence on population based approach to hypertension control. This is a community based cluster randomized trial involving family based health education through female community health volunteers in Nepal. People ≥25 years of age and who are listed in the voter list 2006 of Electoral Commission of Nepal who were either hypertensive, pre-hypertensive or normotensive are eligible for eligible for participation in the study. A computer generated random codes will be used to divide clusters into treatment and control arm. FCHVs will conduct family based health education and blood pressure measurements in the treatment arm vs not any interventions in control arm. Independent assessors will conduct the baseline and end line assessment of the intervention. Intention to treat analysis and per protocol analysis will be used in analysis to detect significant differences between treatment and control group participants at baseline and follow up. Student t-tests for normally distributed variables and chi-squared tests for categorical variables will be used. In the event that randomization do not control for differences between the treatment and control groups on baseline characteristics, the investigators will statistically control for those differences in subsequent analysis of program effects. The final outcome will be modeled by using multiple linear regressions analysis. The investigators hope that if the intervention outcomes shows positive effects in treatment arm, this approach can be adopted into the existing health care delivery system in Nepal. Assessing the FCHVs' ability may further contribute to developing a policy that can be scaled-up to a national level. The lessons learned from this project may also be replicated in rural areas and similar settings elsewhere in the world.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| FCHV visit-normotensive | Experimental | Behavioral: FCHV visit |
| FCHV no visit-normotensive | No intervention | – |
| FCHV visit-prehypertensive | Experimental | Behavioral: FCHV visit |
| FCHV no visit-prehypertensive | No intervention | – |
| FCHV visit-hypertensive | Experimental | Behavioral: FCHV visit |
| FCHV no visit-hypertensive | No intervention | – |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- People ≥25 years of age and who are listed in the voter list of 2006 and those participated in our prevalence study are eligible for inclusion in the baseline survey. - Person who give consent to participate in our intervention study,
- does not have any plan to migrate from Lekhnath Municipality for at least 1 year,
- non-pregnant women and
- personal who are not severely ill will be included as eligible participants.
Key exclusion criteria (4 listed)
- No consent
- Pregnant women
- Severely Il
- Plan for migration for the study municipality within 1 year
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 |
|---|---|---|
| FCHV visitAlso: FCHV Home VisitFemale Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure | Behavioural | FCHV visit-hypertensive, FCHV visit-normotensive, FCHV visit-prehypertensive |
Primary outcome
Change in mean systolic blood pressure in normotensive, pre-hypertensive and hypertensive populations
Time frame: 1 year
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 24 Feb 2017.
- Derived from this study: PubMed 34385256Paudel S, Subedi N, McLachlan CS, Smith BJ, Kallestrup P, Neupane D. Active commuting and leisure-time physical activity among adults in western Nepal: a cross-sectional study. BMJ Open. 2021 Aug 12;11(8):e051846. doi: 10.1136/bmjopen-2021-051846.
- Derived from this study: PubMed 29241617Neupane D, McLachlan CS, Mishra SR, Olsen MH, Perry HB, Karki A, Kallestrup P. Effectiveness of a lifestyle intervention led by female community health volunteers versus usual care in blood pressure reduction (COBIN): an open-label, cluster-randomised trial. Lancet Glob Health. 2018 Jan;6(1):e66-e73. doi: 10.1016/S2214-109X(17)30411-4.
- Derived from this study: PubMed 27316539Neupane D, McLachlan CS, Christensen B, Karki A, Perry HB, Kallestrup P. Community-based intervention for blood pressure reduction in Nepal (COBIN trial): study protocol for a cluster-randomized controlled trial. Trials. 2016 Jun 18;17(1):292. doi: 10.1186/s13063-016-1412-3.
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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.
Dinesh Neupane, PhD Fellow principal investigator
Center for Global Health, Aarhus University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCHV visit in people with Hypertension, run by University of Aarhus 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 4 inclusion and 4 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 24 Feb 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?
Change in mean systolic blood pressure in normotensive, pre-hypertensive and hypertensive populations (time frame: 1 year). 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 NCT02428075, which also lists 3 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 24 Feb 2017.