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Population Based Strategies for Effective Control of High Blood Pressure in Pakistan

Primary Purpose

Hypertension, Cardiovascular Disease, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Home heath education +/_ GP training
Sponsored by
Aga Khan University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All subjects aged 5 years or over residing in randomly selected communities Exclusion Criteria: Those who have severe co-morbid conditions Pregnancy Unable to give informed consent

Sites / Locations

  • Aga Khan University

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
May 17, 2006
Last Updated
May 25, 2006
Sponsor
Aga Khan University
Collaborators
Wellcome Trust, Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT00327574
Brief Title
Population Based Strategies for Effective Control of High Blood Pressure in Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Aga Khan University
Collaborators
Wellcome Trust, Imperial College London

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Disease, Obesity, Diabetes, Kidney Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Home heath education +/_ GP training
Primary Outcome Measure Information:
Title
Cross sectional: The prevalence (95% confidence intervals) of CVD, hypertension, diabetes, albuminuria, and mean values of lipid.
Title
Intervention study: Changes in systolic and diastolic BP,
Title
b) body mass index (BMI), e) waist hip ratio, and f) tobacco use from baseline to 2 year follow up visit
Title
Cost Outcome Measures: These will be computed for hypertensive adults.
Title
Primary outcomes: incremental cost per mm reduction in SBP, and DBP for each of the three intervention arms.
Title
the three intervention arms
Secondary Outcome Measure Information:
Title
Secondary Effect Outcomes: a) Proportion of subjects with mean follow-up BP less than 140/90 mm Hg,
Title
and changes in b) BMI, c) waist hip ratio, and f) tobacco use.
Title
Cost outcomes: the total cost per intervention and cost per subjects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects aged 5 years or over residing in randomly selected communities Exclusion Criteria: Those who have severe co-morbid conditions Pregnancy Unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tazeen H Jafar, MD MPH
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sind
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
16086922
Citation
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.
Results Reference
background
PubMed Identifier
12714864
Citation
Jafar 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.
Results Reference
background
PubMed Identifier
26540210
Citation
Jafar 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.
Results Reference
derived
PubMed Identifier
21509050
Citation
Almas 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.
Results Reference
derived
PubMed Identifier
20530082
Citation
Jafar 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.
Results Reference
derived
PubMed Identifier
19884620
Citation
Jafar 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.
Results Reference
derived
PubMed Identifier
17646192
Citation
Jafar 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.
Results Reference
derived

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Population Based Strategies for Effective Control of High Blood Pressure in Pakistan

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