NCT00330408

Brief Summary

This study aims to assess the impact of training General Practitioners (GPs) on adherence to antihypertensive medication among hypertensive individuals. It also aims to assess risk factors for non-adherence. Special training (in appropriate algorithms for management and patient involvement in therapeutic decision making) has been given to GPs. The study has been conducted in six middle or low income clusters of Karachi recruiting individuals randomized to specially trained or untrained GPs, with a follow-up period of 6 weeks. The medication event monitoring system (MEMS)has been used for assessing adherence. It is hypothesized that compliance levels of individuals going to specially trained GPs is higher compared to those going to GPs not having received special training.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2006

Completed
Last Updated

May 26, 2006

Status Verified

April 1, 2006

First QC Date

May 25, 2006

Last Update Submit

May 25, 2006

Conditions

Hypertension

Keywords

AdherenceGP trainingMedication Event Monitoring System(MEMS)Antihypertensive MedicationHypertension

Outcome Measures

Primary Outcomes (1)

  • adherence:% of days correct dose was taken

Secondary Outcomes (1)

  • adherence: % prescribed doses taken

Interventions

GP trainingBEHAVIORAL

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertensive individuals aged 40 years and above residing in selected clusters
  • Individuals prescribed with hypertensive medication by their general practitioners in related cluster

You may not qualify if:

  • Pregnant women will be excluded
  • Mentally unstable or bed bound patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

  • Qureshi NN, Hatcher J, Chaturvedi N, Jafar TH; Hypertension Research Group. Effect of general practitioner education on adherence to antihypertensive drugs: cluster randomised controlled trial. BMJ. 2007 Nov 17;335(7628):1030. doi: 10.1136/bmj.39360.617986.AE. Epub 2007 Nov 8.

    PMID: 17991935DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Tazeen H Jafar, MD, MPH

    Aga Khan Univeristy

    STUDY DIRECTOR

  • Nudrat Qureshi, MSc Genetics

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2006

First Posted

May 26, 2006

Study Start

September 1, 2005

Study Completion

April 1, 2006

Last Updated

May 26, 2006

Record last verified: 2006-04

Locations

PA(1)