HypertensionNCT00327574
Population Based Strategies for Effective Control of High Blood Pressure in Pakistan
A study testing Home heath education +/_ GP training in people with Hypertension and Cardiovascular Disease, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Studies have established that high blood pressure (BP) is the most common risk factor for cardiovascular disease (CVD). Despite a heavy burden of hypertension (33% of all persons aged 45 years and over), there are no reliable data on comparative strategies to manage hypertension in Pakistan. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Disease, Obesity
- What is being tested?
- Home heath education +/_ GP training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 sitePakistan
- Study dates
- Jun 2004to Sep 2007
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All subjects aged 5 years or over residing in randomly selected communities
Who cannot join
- Those who have severe co-morbid conditions
- Pregnancy
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Studies have established that high blood pressure (BP) is the most common risk factor for cardiovascular disease (CVD). Despite a heavy burden of hypertension (33% of all persons aged 45 years and over), there are no reliable data on comparative strategies to manage hypertension in Pakistan. Our Wellcome Trust funded pilot study in Karachi, Pakistan on 320 adults aged 40 years and over showed that the prevalence of hypertension (95% CI) was 40.3% (34.9-45.7%), and CVD was 32.5% (27.6-37.8%).
We will now conduct a study with two components: 1) cross sectional study to determine the prevalence of CVD, and its determinants in Karachi, Pakistan; and 2) prospective, 2x2 factorial design, cluster allocation intervention study to evaluate the impact of a i) Population approach of household health education (HHE) by community health workers (CHW) on BP levels of population aged 5 years or over in low-middle income communities of Karachi; and ii) High-Risk approach of special BP management administered by intensively trained local general practitioners on BP levels of hypertensive subjects aged > = 40 years from the above population.
Read more
The cost effective BP control strategy would serve as a model for a much-needed national level hypertension control programme in Pakistan, and possibly other developing countries in South Asia.
We hypothesize that 1) HHE delivered by trained CHW is superior to no HHE in lowering BP levels of the population; and 2) management of hypertension by specially trained GPs is better than usual care provided in the communities of Karachi in lowering blood pressure of hypertensive subjects.
Read the detailed description
The proposed study will be conducted among the low and middle-income population in Karachi. This population is likely to be particularly prone to CVD, has the poorest access to quality care, and is often prescribed expensive drugs by GPs.
Screening visit: The Community Health Workers (CHW) will pay home visits to invite all subjects aged 5 years or over to participate in the survey. The screening would have three levels: 1) Household screening for subjects aged 5 years and over (n= 17,850 individuals, 3000 households). 2) Adult screening for individuals aged 40 years or over (n= 4200 individuals). 3) Hypertensive adults screening (n= 1860 individuals) for those identified to have hypertension on adult screening will be invited for re-measurement of BP to confirm hypertension.
Intervention Effectiveness Study: This is a 2x2 factorial design, cluster allocation intervention study comparing controls with intervention by primary care GP, with or without health education. The main comparisons relate to the reduction of BP in a) all household members (aged > 5 years), and b) hypertensive adults (aged > 40 years).
Interventions: The sample will be assigned to four intervention groups:
- Group A: Routine care.
- Group B: Routine care plus Health Education
- Group C: Care provided by trained GP
- Group D: Care provided by trained GP plus Health Education.
- Conditions
- Hypertension, Cardiovascular Disease, Obesity, Diabetes, Kidney Disease
- Being tested
- Home heath education +/_ GP training
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Obesity, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home heath education +/_ GP trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional: The prevalence (95% confidence intervals) of CVD, hypertension, diabetes, albuminuria, and mean values of lipid.
Intervention study: Changes in systolic and diastolic BP,
b) body mass index (BMI), e) waist hip ratio, and f) tobacco use from baseline to 2 year follow up visit
Cost Outcome Measures: These will be computed for hypertensive adults.
Primary outcomes: incremental cost per mm reduction in SBP, and DBP for each of the three intervention arms.
the three intervention arms
Secondary outcomes (3)
Secondary Effect Outcomes: a) Proportion of subjects with mean follow-up BP less than 140/90 mm Hg,
and changes in b) BMI, c) waist hip ratio, and f) tobacco use.
Cost outcomes: the total cost per intervention and cost per subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startJun 2004
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Factorial
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Imperial College London
- Investigators
- Tazeen H Jafar, MD MPH, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327574
- Sponsor's protocol ID
- GR 070854
- Status last verified
- May 2006
- First submitted
- 17 May 2006
- Last updated
- 26 May 2006
- Results posted
- No
Publications
Jafar TH, Jafary FH, Jessani S, Chaturvedi N. Heart disease epidemic in Pakistan: women and men at equal risk. Am Heart J. 2005 Aug;150(2):221-6. doi: 10.1016/j.ahj.2004.09.025.
PubMed 16086922Jafar TH, Levey AS, Jafary FH, White F, Gul A, Rahbar MH, Khan AQ, Hattersley A, Schmid CH, Chaturvedi N. Ethnic subgroup differences in hypertension in Pakistan. J Hypertens. 2003 May;21(5):905-12. doi: 10.1097/00004872-200305000-00014.
PubMed 12714864Jafar TH, Jehan I, Liang F, Barbier S, Islam M, Bux R, Khan AH, Nadkarni N, Poulter N, Chaturvedi N, Ebrahim S. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups. PLoS One. 2015 Nov 5;10(11):e0140550. doi: 10.1371/journal.pone.0140550. eCollection 2015.
PubMed 26540210Almas A, Jafar TH. Adiposity and blood pressure in South Asian children and adolescents in Karachi. Am J Hypertens. 2011 Aug;24(8):876-80. doi: 10.1038/ajh.2011.67. Epub 2011 Apr 21.
PubMed 21509050Jafar TH, Islam M, Hatcher J, Hashmi S, Bux R, Khan A, Poulter N, Badruddin S, Chaturvedi N; Hypertension Research Group. Community based lifestyle intervention for blood pressure reduction in children and young adults in developing country: cluster randomised controlled trial. BMJ. 2010 Jun 7;340:c2641. doi: 10.1136/bmj.c2641.
PubMed 20530082Jafar TH, Hatcher J, Poulter N, Islam M, Hashmi S, Qadri Z, Bux R, Khan A, Jafary FH, Hameed A, Khan A, Badruddin SH, Chaturvedi N; Hypertension Research Group. Community-based interventions to promote blood pressure control in a developing country: a cluster randomized trial. Ann Intern Med. 2009 Nov 3;151(9):593-601. doi: 10.7326/0003-4819-151-9-200911030-00004.
PubMed 19884620Jafar TH, Qadri Z, Chaturvedi N. Coronary artery disease epidemic in Pakistan: more electrocardiographic evidence of ischaemia in women than in men. Heart. 2008 Apr;94(4):408-13. doi: 10.1136/hrt.2007.120774. Epub 2007 Jul 23.
PubMed 17646192
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Based Strategies for Effective Control of High Blood Pressure in Pakistan
- ClinicalTrials.gov ID
- NCT00327574
- Acronym / sponsor ID
- GR 070854
- Conditions
- Hypertension, Cardiovascular Disease, Obesity, Diabetes, Kidney Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Wellcome Trust, Imperial College London
- Study start
- Jun 2004
- Study completion
- Sep 2007
- First posted
- 18 May 2006 (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.
Studies have established that high blood pressure (BP) is the most common risk factor for cardiovascular disease (CVD). Despite a heavy burden of hypertension (33% of all persons aged 45 years and over), there are no reliable data on comparative strategies to manage hypertension in Pakistan. Our Wellcome Trust funded pilot study in Karachi, Pakistan on 320 adults aged 40 years and over showed that the prevalence of hypertension (95% CI) was 40.3% (34.9-45.7%), and CVD was 32.5% (27.6-37.8%).
We will now conduct a study with two components: 1) cross sectional study to determine the prevalence of CVD, and its determinants in Karachi, Pakistan; and 2) prospective, 2x2 factorial design, cluster allocation intervention study to evaluate the impact of a i) Population approach of household health education (HHE) by community health workers (CHW) on BP levels of population aged 5 years or over in low-middle income communities of Karachi; and ii) High-Risk approach of special BP management administered by intensively trained local general practitioners on BP levels of hypertensive subjects aged > = 40 years from the above population.
The cost effective BP control strategy would serve as a model for a much-needed national level hypertension control programme in Pakistan, and possibly other developing countries in South Asia.
We hypothesize that 1) HHE delivered by trained CHW is superior to no HHE in lowering BP levels of the population; and 2) management of hypertension by specially trained GPs is better than usual care provided in the communities of Karachi in lowering blood pressure of hypertensive subjects.
Detailed description
The proposed study will be conducted among the low and middle-income population in Karachi. This population is likely to be particularly prone to CVD, has the poorest access to quality care, and is often prescribed expensive drugs by GPs.
Screening visit: The Community Health Workers (CHW) will pay home visits to invite all subjects aged 5 years or over to participate in the survey. The screening would have three levels: 1) Household screening for subjects aged 5 years and over (n= 17,850 individuals, 3000 households). 2) Adult screening for individuals aged 40 years or over (n= 4200 individuals). 3) Hypertensive adults screening (n= 1860 individuals) for those identified to have hypertension on adult screening will be invited for re-measurement of BP to confirm hypertension.
Intervention Effectiveness Study: This is a 2x2 factorial design, cluster allocation intervention study comparing controls with intervention by primary care GP, with or without health education. The main comparisons relate to the reduction of BP in a) all household members (aged > 5 years), and b) hypertensive adults (aged > 40 years).
Interventions: The sample will be assigned to four intervention groups:
- Group A: Routine care.
- Group B: Routine care plus Health Education
- Group C: Care provided by trained GP
- Group D: Care provided by trained GP plus Health Education.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects aged 5 years or over residing in randomly selected communities
Key exclusion criteria (3 listed)
- Those who have severe co-morbid conditions
- Pregnancy
- Unable to give informed consent
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 |
|---|---|---|
| Home heath education +/_ GP training | Behavioural | – |
Primary outcome
Cross sectional: The prevalence (95% confidence intervals) of CVD, hypertension, diabetes, albuminuria, and mean values of lipid.
Intervention study: Changes in systolic and diastolic BP,
b) body mass index (BMI), e) waist hip ratio, and f) tobacco use from baseline to 2 year follow up visit
Cost Outcome Measures: These will be computed for hypertensive adults.
Primary outcomes: incremental cost per mm reduction in SBP, and DBP for each of the three intervention arms.
the three intervention arms
3 secondary outcomes
Secondary Effect Outcomes: a) Proportion of subjects with mean follow-up BP less than 140/90 mm Hg,
and changes in b) BMI, c) waist hip ratio, and f) tobacco use.
Cost outcomes: the total cost per intervention and cost per subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2006.
- Background: PubMed 16086922Jafar TH, Jafary FH, Jessani S, Chaturvedi N. Heart disease epidemic in Pakistan: women and men at equal risk. Am Heart J. 2005 Aug;150(2):221-6. doi: 10.1016/j.ahj.2004.09.025.
- Background: PubMed 12714864Jafar TH, Levey AS, Jafary FH, White F, Gul A, Rahbar MH, Khan AQ, Hattersley A, Schmid CH, Chaturvedi N. Ethnic subgroup differences in hypertension in Pakistan. J Hypertens. 2003 May;21(5):905-12. doi: 10.1097/00004872-200305000-00014.
- Derived from this study: PubMed 26540210Jafar TH, Jehan I, Liang F, Barbier S, Islam M, Bux R, Khan AH, Nadkarni N, Poulter N, Chaturvedi N, Ebrahim S. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups. PLoS One. 2015 Nov 5;10(11):e0140550. doi: 10.1371/journal.pone.0140550. eCollection 2015.
- Derived from this study: PubMed 21509050Almas A, Jafar TH. Adiposity and blood pressure in South Asian children and adolescents in Karachi. Am J Hypertens. 2011 Aug;24(8):876-80. doi: 10.1038/ajh.2011.67. Epub 2011 Apr 21.
- Derived from this study: PubMed 20530082Jafar TH, Islam M, Hatcher J, Hashmi S, Bux R, Khan A, Poulter N, Badruddin S, Chaturvedi N; Hypertension Research Group. Community based lifestyle intervention for blood pressure reduction in children and young adults in developing country: cluster randomised controlled trial. BMJ. 2010 Jun 7;340:c2641. doi: 10.1136/bmj.c2641.
- Derived from this study: PubMed 19884620Jafar TH, Hatcher J, Poulter N, Islam M, Hashmi S, Qadri Z, Bux R, Khan A, Jafary FH, Hameed A, Khan A, Badruddin SH, Chaturvedi N; Hypertension Research Group. Community-based interventions to promote blood pressure control in a developing country: a cluster randomized trial. Ann Intern Med. 2009 Nov 3;151(9):593-601. doi: 10.7326/0003-4819-151-9-200911030-00004.
- Derived from this study: PubMed 17646192Jafar TH, Qadri Z, Chaturvedi N. Coronary artery disease epidemic in Pakistan: more electrocardiographic evidence of ischaemia in women than in men. Heart. 2008 Apr;94(4):408-13. doi: 10.1136/hrt.2007.120774. Epub 2007 Jul 23.
Related trials for Hypertension
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
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.
Tazeen H Jafar, MD MPH principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home heath education +/_ GP training in people with Hypertension and Cardiovascular Disease, run by Aga Khan University at 1 site in Pakistan.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 May 2006. 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 Pakistan. 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?
Results are not available in the source record.
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?
Cross sectional: The prevalence (95% confidence intervals) of CVD, hypertension, diabetes, albuminuria, and mean values of lipid.. The study lists 6 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 NCT00327574, which also lists 7 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 26 May 2006; AzTrials last refreshed its copy on 7 Nov 2026.