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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
GP training
Sponsored by
Aga Khan University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Hypertension focused on measuring Adherence, GP training, Medication Event Monitoring System(MEMS), Antihypertensive Medication, Hypertension

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aga Khan University

Outcomes

Primary Outcome Measures

adherence:% of days correct dose was taken

Secondary Outcome Measures

adherence: % prescribed doses taken

Full Information

First Posted
May 25, 2006
Last Updated
May 25, 2006
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT00330408
Brief Title
Impact of Training of GPs on Adherence of Hypertensive Individuals to Antihypertensive Medication
Official Title
Impact of Training of GPs on Adherence of Hypertensive Individuals to Antihypertensive Medication
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Aga Khan University

4. Oversight

5. 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.
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: To assess difference in adherence to antihypertensive medication among hypertensive individuals visiting specially trained GPs, versus those visiting untrained GPs. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Adherence, GP training, Medication Event Monitoring System(MEMS), Antihypertensive Medication, Hypertension

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
GP training
Primary Outcome Measure Information:
Title
adherence:% of days correct dose was taken
Secondary Outcome Measure Information:
Title
adherence: % prescribed doses taken

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tazeen H Jafar, MD, MPH
Organizational Affiliation
Aga Khan Univeristy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nudrat Qureshi, MSc Genetics
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17991935
Citation
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.
Results Reference
derived

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

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