Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330408
Status:
UNKNOWN
Last Update Posted:
2006-05-26
First Post:
2006-05-25
Brief Title:
Impact of Training of GPs on Adherence of Hypertensive Individuals to Antihypertensive Medication
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Impact of Training of GPs on Adherence of Hypertensive Individuals to Antihypertensive Medication
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MEMShas 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None