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Impact of Training of GPs on Adherence of Hypertensive Individuals to Antihypertensive Medication

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ClinicalTrials.gov Identifier: NCT00330408
Recruitment Status : Unknown
Verified April 2006 by Aga Khan University.
Recruitment status was:  Active, not recruiting
First Posted : May 26, 2006
Last Update Posted : May 26, 2006
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Hypertension Behavioral: GP training

Detailed Description:

Background: Lack of medication compliance is reported as a major factor contributing to inadequate control over blood pressure. Data from well-structured and well-conducted researches in this field, specifically in the context of developing countries is lacking.

Rationale: Targeting factors associated with non-adherence identified in this study would lead to reduction of the burden of poorly controlled hypertension and its complications. The special training of GPs, taken as an intervention in this study, if found successful in improving compliance, would be advocated for inclusion in a nation-wide hypertension control program.


  1. To assess difference in adherence to antihypertensive medication among hypertensive individuals visiting specially trained GPs, versus those visiting untrained GPs.
  2. To assess risk factors associated with non-adherence

Study Design: Randomised Controlled Trial

Parent Study: This project stems from the population-based parent study “Population based strategies for effective control of high blood pressure in Pakistan”; a factorial design study. It is being conducted in twelve middle to low socioeconomic clusters of Karachi. These clusters are randomised to care by specially trained general practitioners (GP) vs. untrained GPs. Special training of GPs include rigorously training in appropriate algorithms for management, and patient involvement in therapeutic decision making.

Methodology: The target population for this study has been drawn from the parent study. 6 clusters randomized to the GP training intervention were selected. The specially trained GPs from the parent study are the intervention in this research. Hypertensive individuals from within the chosen clusters have been randomly selected for enrollment in the study. Patients going to specially trained or untrained GPs were taken as exposed or unexposed to the intervention, and were followed up for a month and a half months, in order to assess their adherence to antihypertensive medication. Adherence was further assessed with the help of the Medication Event Monitoring System (MEMS), which gives the date and time of when each bottle was opened. this method does not however ensure ingestion of the drug.

Intervention: GPs trained in appropriate algorithms for management and patient involvement in therapeutic decision making

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Impact of Training of GPs on Adherence of Hypertensive Individuals to Antihypertensive Medication
Study Start Date : September 2005
Estimated Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. adherence:% of days correct dose was taken

Secondary Outcome Measures :
  1. adherence: % prescribed doses taken

Eligibility Criteria

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330408

Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Study Director: Tazeen H Jafar, MD, MPH Aga Khan Univeristy
Principal Investigator: Nudrat Qureshi, MSc Genetics Aga Khan University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00330408     History of Changes
Other Study ID Numbers: 05GS002MSC
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: May 26, 2006
Last Verified: April 2006

Keywords provided by Aga Khan University:
GP training
Medication Event Monitoring System(MEMS)
Antihypertensive Medication

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents