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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00330408
• Other study ID #: 05GS002MSC
• Status: Active, not recruiting
• Phase: N/A
• First received: May 25, 2006
• Last updated: May 25, 2006
• Start date: September 2005
• Est. completion date: April 2006

Study information

• Verified date: April 2006
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Pakistan medical Research Council
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 178
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• GP training

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence:% of days correct dose was taken
Secondary	adherence: % prescribed doses taken