HypertensionSEHATNCT02115711
Study of a Community Based Approach to Control Cardiovascular Risk Factors in India
A study testing Community health worker in people with Hypertension and Diabetes, run by University Hospitals Cleveland Medical Center at 1 site in India.
Trial summary
The study is a 2 year community based cluster randomized controlled trial to assess the role that a community health worker led intervention, in concert with physician education, can play in controlling the principal cardiovascular risk factors, i.e. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Hypertension, Diabetes, Smoking
- What is being tested?
- Community health worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,242 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2014to May 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All individuals between the ages of 35 and 70 and residing in the area allotted to the CHW will be offered screening.
- Of the screened individuals, those with at least 1 cardiovascular risk factor (either one of Hypertension (BP>140/90), Diabetes (FBG >126) or current daily smoker (self-reported) will be enrolled in the study.
Who cannot join
- Individuals who are bed-bound because of acute illness, or have a chronic condition that makes them bed-bound.
- Individuals who refuse consent
- Individuals who do not reside in the community and are only visiting, therefore being unlikely to be available for continuous follow up. Individuals who have stayed less than 6 months in the study area, or whose name is not on the voter list of the area will be excluded.
- Individuals who are not able to participate in the intervention due to significant disabilities, such as blindness, deafness or the intellectually disabled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community Based Approach to Promote Cardiovascular Risk Factor Control in India, Project SEHAT: A Cluster Randomized Controlled Trial
The study is a 2 year community based cluster randomized controlled trial to assess the role that a community health worker led intervention, in concert with physician education, can play in controlling the principal cardiovascular risk factors, i.e. hypertension, tobacco use, diabetes mellitus, physical inactivity and an unhealthy diet. Participants will include around 3600 adults, 35-70 years of age, from the urban community in the town of Dalkhola, Uttar Dinajpur district, West Bengal, India. The hypothesis of the study is that a community health worker based approach can result in increased control of Hypertension, Diabetes and Smoking.
Read the detailed description
India is currently in the throes of an emerging epidemic of cardiovascular diseases as evidenced by the rising trends in hypertension, smoking and diabetes prevalence observed in the past decade. The country is currently ill equipped to handle this massive problem of chronic diseases. One of the proposed models to address this problem at the primary care level is to expand the pre-existing infrastructure of community health workers that deliver maternal and child health care for screening and management of NCDs. The investigators propose a cluster randomized control study to test the effectiveness of community health workers (CHW) in controlling the three most prevalent cardiovascular risk factors in an integrated manner - hypertension, smoking and diabetes.
The investigators plan to screen around 3600 individuals between the age of 35 and 70 for hypertension, diabetes and smoking from 12 randomly selected clusters in the economically backward urban town of Dalkhola (WB). The screening will be done using house to house visits by CHWs who will administer a questionnaire based on the WHO STEPS survey, measure individual blood pressures and fasting blood glucose. The individuals identified as having atleast one of these risk factors will be eligible for further participation in the study. The clusters will be randomized to either receive the CHW intervention or usual care.
CHWs will be used as the change agents to provide health education, serve as community advocates, and collect data for this study .These CHWs will be chosen from the study population based on a set of criteria through a formal selection panel after consulting with the local leaders and physicians. They will undergo a week of training for the screening process, an additional week for the intervention and finally a refresher course every 6 months. The CHW remunerations will be based on a system of incentives ranging from a minimum of Rs. 12,000 p.a to a maximum of 20,000 p.a.
The intervention is a multi-component one that is tailored to the individual and will target lifestyle changes, health seeking behavior and medication compliance. The CHW intervention will be implemented in a phased manner (2 phases) as is appropriate for multi-component interventions. The CHW after identifying the cardiovascular risk factors will give advice about lifestyle interventions and information about cardiovascular diseases and the benefits of treatment in a one hour session. She will tailor the daily family menu and make appropriate dietary recommendations within the economic context of the family. She will encourage hypertensives and diabetics to seek a physician. The first phase of the intervention will target hypertension, while the second phase which will be introduced 6 months after the first visit will target diabetes and smoking. The CHW will continue visiting the home of the participants every 2 months to reinforce the previous recommendations, seek to address reasons for non-adherence, address knowledge deficits and encourage physician visits. The control group, during their screening visit, will be informed of their problems, given a brief pamphlet and encouraged to seek physician help.
- Conditions
- Hypertension, Diabetes, Smoking, Cardiovascular Diseases
- Being tested
- Community health worker
- Keywords
- India, Cardiovascular risk factors, Community health workers, Hypertension, Diabetes, Smoking
- Medical subject headings
- Hypertension, Diabetes Mellitus, Smoking, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health workerBehavioural
The intervention is a multi-component one that is tailored to the individual and will target lifestyle changes, health seeking behavior and medication compliance. The CHW, after identifying the cardiovascular risk factors, will give advice about lifestyle interventions and will encourage hypertensives and diabetics to seek a physician. The first phase of the intervention will target hypertension, while the second phase which will be introduced 6 months after the first visit will target diabetes and smoking. The CHW will continue visiting the home of the participants every 2 months to reinforce the previous recommendations, seek to address reasons for non-adherence, address knowledge deficits and encourage physician visits.
| Study group | Role | What they receive |
|---|---|---|
| Community health worker | Experimental | Home visits by community health worker to deliver the multi-component behavioural intervention targeted at the individual's hypertension, diabetes or smoking. Receives: Behavioral: Community health worker |
| Usual care | No intervention | Patients will receive usual care in the community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute reduction of systolic blood pressure in Hypertensives
Absolute reduction in SBP amongst hypertensives,
.
Measured: 2 years
Absolute reduction in fasting blood glucose amongst Diabetics
Absolute reduction in fasting blood glucose amongst diabetics
Measured: 2 years
Absolute reduction in average number of cigarettes/bidis smoked per day amongst smokers
Absolute reduction in average number of cigarettes/bidis smoked per day amongst smokers
Measured: 2 years
Secondary outcomes (10)
Absolute mean reduction in DBP amongst hypertensives at end of 2 years
Measured: 2 years
Control rates of hypertension at the end of 2 years, control defined as blood pressure less than 140/90
Measured: 2 years
Difference in the Morisky-8 score between the two arms amongst participants who have been prescribed an anti-hypertensive agent at the end of 2 years.
Measured: 2 years
Proportion of diabetics whose fasting blood sugars are controlled, defined as fasting blood glucose <126 at the end of 2 years
Measured: 2 years
Difference in the Morisky-8 score between the two arms amongst participants who have been prescribed a hypoglycemic agent at the end of 2 years.
Measured: 2 years
Proportion of Diabetics who have taken a statin on atleast five of the last seven days as measured at the end of 2 years
Measured: 2 years
Proportion of hypertensive smokers who have taken a statin on atleast five of the last seven days as measured at the end of 2 years
Measured: 2 years
Proportion of Diabetics who have taken aspirin on atleast five of the last seven days as measured at the end of 2 years
Measured: 2 years
Proportion of smokers who have abstained from smoking at the end of 2 years
Measured: 2 years
Absolute mean reduction in weight and waist circumference, for those who are overweight or have increased waist size at baseline, at the end of 2 years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Hospitals Cleveland Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aditya Khetan, University Hospitals Cleveland Medical Center
- Investigators
- Sri Krishna M Mohan, MD, Principal investigator, University Hospitals Cleveland Medical CenterRishab Gupta, MD, Principal investigator, AIIMS, New Delhi, IndiaRichard Josephson, MS, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115711
- Sponsor's protocol ID
- 02-14-22
- Acronym
- SEHAT
- Status last verified
- May 2017
- First submitted
- 4 Apr 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Khetan A, Zullo M, Rani A, Gupta R, Purushothaman R, Bajaj NS, Agarwal S, Madan Mohan SK, Josephson R. Effect of a Community Health Worker-Based Approach to Integrated Cardiovascular Risk Factor Control in India: A Cluster Randomized Controlled Trial. Glob Heart. 2019 Dec;14(4):355-365. doi: 10.1016/j.gheart.2019.08.003. Epub 2019 Sep 12.
PubMed 31523014
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Based Approach to Promote Cardiovascular Risk Factor Control in India, Project SEHAT: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02115711
- Acronym / sponsor ID
- SEHAT / 02-14-22
- Conditions
- Hypertension, Diabetes, Smoking, Cardiovascular Diseases
- Keywords
- India, Cardiovascular risk factors, Community health workers, Hypertension, Diabetes, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,242 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Apr 2014 (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 study is a 2 year community based cluster randomized controlled trial to assess the role that a community health worker led intervention, in concert with physician education, can play in controlling the principal cardiovascular risk factors, i.e. hypertension, tobacco use, diabetes mellitus, physical inactivity and an unhealthy diet. Participants will include around 3600 adults, 35-70 years of age, from the urban community in the town of Dalkhola, Uttar Dinajpur district, West Bengal, India. The hypothesis of the study is that a community health worker based approach can result in increased control of Hypertension, Diabetes and Smoking.
Detailed description
India is currently in the throes of an emerging epidemic of cardiovascular diseases as evidenced by the rising trends in hypertension, smoking and diabetes prevalence observed in the past decade. The country is currently ill equipped to handle this massive problem of chronic diseases. One of the proposed models to address this problem at the primary care level is to expand the pre-existing infrastructure of community health workers that deliver maternal and child health care for screening and management of NCDs. The investigators propose a cluster randomized control study to test the effectiveness of community health workers (CHW) in controlling the three most prevalent cardiovascular risk factors in an integrated manner - hypertension, smoking and diabetes.
The investigators plan to screen around 3600 individuals between the age of 35 and 70 for hypertension, diabetes and smoking from 12 randomly selected clusters in the economically backward urban town of Dalkhola (WB). The screening will be done using house to house visits by CHWs who will administer a questionnaire based on the WHO STEPS survey, measure individual blood pressures and fasting blood glucose. The individuals identified as having atleast one of these risk factors will be eligible for further participation in the study. The clusters will be randomized to either receive the CHW intervention or usual care.
CHWs will be used as the change agents to provide health education, serve as community advocates, and collect data for this study .These CHWs will be chosen from the study population based on a set of criteria through a formal selection panel after consulting with the local leaders and physicians. They will undergo a week of training for the screening process, an additional week for the intervention and finally a refresher course every 6 months. The CHW remunerations will be based on a system of incentives ranging from a minimum of Rs. 12,000 p.a to a maximum of 20,000 p.a.
The intervention is a multi-component one that is tailored to the individual and will target lifestyle changes, health seeking behavior and medication compliance. The CHW intervention will be implemented in a phased manner (2 phases) as is appropriate for multi-component interventions. The CHW after identifying the cardiovascular risk factors will give advice about lifestyle interventions and information about cardiovascular diseases and the benefits of treatment in a one hour session. She will tailor the daily family menu and make appropriate dietary recommendations within the economic context of the family. She will encourage hypertensives and diabetics to seek a physician. The first phase of the intervention will target hypertension, while the second phase which will be introduced 6 months after the first visit will target diabetes and smoking. The CHW will continue visiting the home of the participants every 2 months to reinforce the previous recommendations, seek to address reasons for non-adherence, address knowledge deficits and encourage physician visits. The control group, during their screening visit, will be informed of their problems, given a brief pamphlet and encouraged to seek physician help.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community health worker | Experimental | Behavioral: Community health workerHome visits by community health worker to deliver the multi-component behavioural intervention targeted at the individual's hypertension, diabetes or smoking. |
| Usual care | No intervention | –Patients will receive usual care in the community |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All individuals between the ages of 35 and 70 and residing in the area allotted to the CHW will be offered screening.
- Of the screened individuals, those with at least 1 cardiovascular risk factor (either one of Hypertension (BP>140/90), Diabetes (FBG >126) or current daily smoker (self-reported) will be enrolled in the study.
Key exclusion criteria (4 listed)
- Individuals who are bed-bound because of acute illness, or have a chronic condition that makes them bed-bound.
- Individuals who refuse consent
- Individuals who do not reside in the community and are only visiting, therefore being unlikely to be available for continuous follow up. Individuals who have stayed less than 6 months in the study area, or whose name is not on the voter list of the area will be excluded.
- Individuals who are not able to participate in the intervention due to significant disabilities, such as blindness, deafness or the intellectually disabled.
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 |
|---|---|---|
| Community health workerThe intervention is a multi-component one that is tailored to the individual and will target lifestyle changes, health seeking behavior and medication compliance. The CHW, after identifying the cardiovascular risk factors, will give advice about lifestyle interventions and will encourage hypertensives and diabetics to seek a physician. The first phase of the intervention will target hypertension, while the second phase which will be introduced 6 months after the first visit will target diabetes and smoking. The CHW will continue visiting the home of the participants every 2 months to reinforce the previous recommendations, seek to address reasons for non-adherence, address knowledge deficits and encourage physician visits. | Behavioural | Community health worker |
Primary outcome
Absolute reduction of systolic blood pressure in Hypertensives
Time frame: 2 years
Absolute reduction in SBP amongst hypertensives, .
Absolute reduction in fasting blood glucose amongst Diabetics
Time frame: 2 years
Absolute reduction in fasting blood glucose amongst diabetics
Absolute reduction in average number of cigarettes/bidis smoked per day amongst smokers
Time frame: 2 years
Absolute reduction in average number of cigarettes/bidis smoked per day amongst smokers
10 secondary outcomes
Absolute mean reduction in DBP amongst hypertensives at end of 2 years
Time frame: 2 years
Control rates of hypertension at the end of 2 years, control defined as blood pressure less than 140/90
Time frame: 2 years
Difference in the Morisky-8 score between the two arms amongst participants who have been prescribed an anti-hypertensive agent at the end of 2 years.
Time frame: 2 years
Proportion of diabetics whose fasting blood sugars are controlled, defined as fasting blood glucose <126 at the end of 2 years
Time frame: 2 years
Difference in the Morisky-8 score between the two arms amongst participants who have been prescribed a hypoglycemic agent at the end of 2 years.
Time frame: 2 years
Proportion of Diabetics who have taken a statin on atleast five of the last seven days as measured at the end of 2 years
Time frame: 2 years
Proportion of hypertensive smokers who have taken a statin on atleast five of the last seven days as measured at the end of 2 years
Time frame: 2 years
Proportion of Diabetics who have taken aspirin on atleast five of the last seven days as measured at the end of 2 years
Time frame: 2 years
Proportion of smokers who have abstained from smoking at the end of 2 years
Time frame: 2 years
Absolute mean reduction in weight and waist circumference, for those who are overweight or have increased waist size at baseline, at the end of 2 years.
Time frame: 2 years
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 3 May 2017.
- Derived from this study: PubMed 31523014Khetan A, Zullo M, Rani A, Gupta R, Purushothaman R, Bajaj NS, Agarwal S, Madan Mohan SK, Josephson R. Effect of a Community Health Worker-Based Approach to Integrated Cardiovascular Risk Factor Control in India: A Cluster Randomized Controlled Trial. Glob Heart. 2019 Dec;14(4):355-365. doi: 10.1016/j.gheart.2019.08.003. Epub 2019 Sep 12.
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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.
Sri Krishna M Mohan, MD principal investigator
University Hospitals Cleveland Medical Center
Rishab Gupta, MD principal investigator
AIIMS, New Delhi, India
Richard Josephson, MS, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community health worker in people with Hypertension and Diabetes, run by University Hospitals Cleveland Medical Center at 1 site in India.
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 2 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 3 May 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 India. 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?
Absolute reduction of systolic blood pressure in Hypertensives (time frame: 2 years). The study lists 3 primary outcomes in all. 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 NCT02115711, which also lists 1 linked publication.
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 3 May 2017.