HypertensionNCT00330408
Impact of Training of GPs on Adherence of Hypertensive Individuals to Antihypertensive Medication
A study testing GP training in people with Hypertension, run by Aga Khan University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- GP training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 178 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2005to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive individuals aged 40 years and above residing in selected clusters
- Individuals prescribed with hypertensive medication by their general practitioners in related cluster
Who cannot join
- Pregnant women will be excluded
- Mentally unstable or bed bound patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Hypertension
- Being tested
- GP training
- Keywords
- Adherence, GP training, Medication Event Monitoring System(MEMS), Antihypertensive Medication, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence:% of days correct dose was taken
Secondary outcomes (1)
adherence: % prescribed doses taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startSep 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Tazeen H Jafar, MD, MPH, Study director, Aga Khan UniveristyNudrat Qureshi, MSc Genetics, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330408
- Sponsor's protocol ID
- 05GS002MSC
- Status last verified
- Apr 2006
- First submitted
- 25 May 2006
- Last updated
- 26 May 2006
- Results posted
- No
Publications
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.
PubMed 17991935
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Training of GPs on Adherence of Hypertensive Individuals to Antihypertensive Medication
- ClinicalTrials.gov ID
- NCT00330408
- Acronym / sponsor ID
- 05GS002MSC
- Conditions
- Hypertension
- Keywords
- Adherence, GP training, Medication Event Monitoring System(MEMS), Antihypertensive Medication, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Apr 2006
- First posted
- 26 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hypertensive individuals aged 40 years and above residing in selected clusters
- Individuals prescribed with hypertensive medication by their general practitioners in related cluster
Key exclusion criteria (2 listed)
- Pregnant women will be excluded
- Mentally unstable or bed bound patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP training | Behavioural | – |
Primary outcome
adherence:% of days correct dose was taken
1 secondary outcome
adherence: % prescribed doses taken
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2006.
- Derived from this study: PubMed 17991935Qureshi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tazeen H Jafar, MD, MPH study director
Aga Khan Univeristy
Nudrat Qureshi, MSc Genetics principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GP training in people with Hypertension, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence:% of days correct dose was taken. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2006.