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

NCT00327574 | Unknown

• 1 other identifier: GR 070854
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cardiovascular Disease; Obesity; Diabetes; Kidney Disease

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

Home heath education +/_ GP training BEHAVIORAL

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects aged 5 years or over residing in randomly selected communities

You may not qualify if:

• Those who have severe co-morbid conditions
• Pregnancy
• Unable to give informed consent

Sponsors & Collaborators

• Aga Khan University: lead
• Wellcome Trust: collaborator
• Imperial College London: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 16086922 BACKGROUND

• 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.

  PMID: 12714864 BACKGROUND

• 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.

  PMID: 26540210 DERIVED

• 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.

  PMID: 21509050 DERIVED

• 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.

  PMID: 20530082 DERIVED

• 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.

  PMID: 19884620 DERIVED

• 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.

  PMID: 17646192 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Obesity; Diabetes Mellitus; Kidney Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tazeen H Jafar, MD MPH

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 18, 2006
• Study Start: June 1, 2004
• Study Completion: September 1, 2007
• Last Updated: May 26, 2006

Record last verified: 2006-05

Locations

PA (1)