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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Aga Khan University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00330408
First received: May 25, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

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 Intervention
Hypertension
Behavioral: GP training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Impact of Training of GPs on Adherence of Hypertensive Individuals to Antihypertensive Medication

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

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

Secondary Outcome Measures:
  • adherence: % prescribed doses taken

Estimated Enrollment: 178
Study Start Date: September 2005
Estimated Study Completion Date: April 2006
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.

Aims:

  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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330408

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

No publications provided by Aga Khan University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00330408     History of Changes
Other Study ID Numbers: 05GS002MSC
Study First Received: May 25, 2006
Last Updated: May 25, 2006
Health Authority: Pakistan: Pakistan medical Research Council

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014