HypertensionAPOFNCT02032472
Efficiency of Monitoring and Control Program of Hypertension Through Pharmacy Offices. APOF Project
A study testing Measurement of Arterial Pressure in people with Hypertension, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Background: Hypertension in adults is the factor most prevalent cardiovascular risk and motivates further inquiries, generating a very high cost of medical care. Objective: To evaluate the monitoring of well-controlled hypertensive patients Pharmacy Offices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Measurement of Arterial Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 677 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age not less than 18 years
- HTA controlled over 2 years of evolution
- Subjects with a history open to participating health centers or stable residence in the geographic area
- Subjects who agree to participate
Who cannot join
- Comorbidity and concomitant (Diabetes Mellitus, Heart failure or renal failure
- Patients with temporary residence in the geographic area of study
- Subjects of hypertension controlled by outside professionals to our primary care teams.
- Subjects with home care or any other cause which does not permit their displacement, transfer to the clinic or pharmacy during the evaluation period.
- Subjects with severe diseases of poor prognosis, hopefully less than one year of life.
- Subjects who do not have telephones.
- Subjects with communication problems (cognitive impairment, sensory, language barrier)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Català de la Salut (ICS)
Cerdanyola Del Valllés, Barcelona, 08290
About this study
Official title: Efficiency Program Monitoring and Control of Hypertension Through Pharmacy Offices. APOF Project
Background: Hypertension in adults is the factor most prevalent cardiovascular risk and motivates further inquiries, generating a very high cost of medical care.
Objective: To evaluate the monitoring of well-controlled hypertensive patients Pharmacy Offices. Hypothesis: the monitoring of these patients through the Office of Pharmacy will be as effective in obtaining good control of blood pressure as it is to obtained through health centers. Design: Multicenter randomized controlled trial along one year of follow up. Location: the city of Cerdanyola del Vallès (Barcelona). Participants: All patients diagnosed with hypertension and good control criteria in the past year. Arms: Health centers (control) and Pharmacy Offices (intervention). Outcome variable: blood pressure under good control along the monitoring
- Conditions
- Hypertension
- Being tested
- Measurement of Arterial Pressure
- Keywords
- Blood Pressure Monitoring, Ambulatory, Arterial Pressure, Hypertension Controlled, Pharmacies
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Arterial PressureOther
Pharmacies cooperate in measuring blood pressure of patients
| Study group | Role | What they receive |
|---|---|---|
| Health Center (usual practice) | No intervention | Controlling arterial pressure in the health center (a common practice is carried out) |
| Collaboration of pharmacies | Experimental | Pharmacies cooperate in Measurement of Arterial Pressure of patients Receives: Other: Measurement of Arterial Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of hypertensive patients with criteria for good control of their arterial pressure along one year follow up
We considered as a for good control criterion , obtaining values of systolic arterial pressure to below 140 mm Hg and diastolic blood pressure below 90 mm Hg dea, held along the entire the year follow-up of patients
Measured: Monitoring of patients for 12 months (from January 1 to December 31, 2010)
Secondary outcomes (1)
reduction in the number of visits to the health center to measure blood pressure
The number of visits to the health center where blood pressure is measured. We hope that the number of visits to the health center where blood pressure is measured is lower in the intervention group (the patients have the option to go to the pharmacy to carrying out checks blood pressure)
Measured: Monitoring of patients for 12 months (from January 1 to December 31, 2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut
- Responsible party
- Sponsor
- Investigators
- Oscar Solans, G Physician, Principal investigator, Institut Català de la Salut (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032472
- Sponsor's protocol ID
- APOF_IDIAP
- Acronym
- APOF
- Status last verified
- Jan 2014
- First submitted
- 23 Dec 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Program Monitoring and Control of Hypertension Through Pharmacy Offices. APOF Project
- ClinicalTrials.gov ID
- NCT02032472
- Acronym / sponsor ID
- APOF / APOF_IDIAP
- Conditions
- Hypertension
- Keywords
- Blood Pressure Monitoring, Ambulatory, Arterial Pressure, Hypertension Controlled, Pharmacies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Catala de Salut
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Jan 2014 (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.
Background: Hypertension in adults is the factor most prevalent cardiovascular risk and motivates further inquiries, generating a very high cost of medical care.
Objective: To evaluate the monitoring of well-controlled hypertensive patients Pharmacy Offices. Hypothesis: the monitoring of these patients through the Office of Pharmacy will be as effective in obtaining good control of blood pressure as it is to obtained through health centers. Design: Multicenter randomized controlled trial along one year of follow up. Location: the city of Cerdanyola del Vallès (Barcelona). Participants: All patients diagnosed with hypertension and good control criteria in the past year. Arms: Health centers (control) and Pharmacy Offices (intervention). Outcome variable: blood pressure under good control along the monitoring
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Center (usual practice) | No intervention | –Controlling arterial pressure in the health center (a common practice is carried out) |
| Collaboration of pharmacies | Experimental | Other: Measurement of Arterial PressurePharmacies cooperate in Measurement of Arterial Pressure of patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age not less than 18 years
- HTA controlled over 2 years of evolution
- Subjects with a history open to participating health centers or stable residence in the geographic area
- Subjects who agree to participate
Key exclusion criteria (7 listed)
- Comorbidity and concomitant (Diabetes Mellitus, Heart failure or renal failure
- Patients with temporary residence in the geographic area of study
- Subjects of hypertension controlled by outside professionals to our primary care teams.
- Subjects with home care or any other cause which does not permit their displacement, transfer to the clinic or pharmacy during the evaluation period.
- Subjects with severe diseases of poor prognosis, hopefully less than one year of life.
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 |
|---|---|---|
| Measurement of Arterial PressurePharmacies cooperate in measuring blood pressure of patients | Other | Collaboration of pharmacies |
Primary outcome
Percentage of hypertensive patients with criteria for good control of their arterial pressure along one year follow up
Time frame: Monitoring of patients for 12 months (from January 1 to December 31, 2010)
We considered as a for good control criterion , obtaining values of systolic arterial pressure to below 140 mm Hg and diastolic blood pressure below 90 mm Hg dea, held along the entire the year follow-up of patients
1 secondary outcome
reduction in the number of visits to the health center to measure blood pressure
Time frame: Monitoring of patients for 12 months (from January 1 to December 31, 2010)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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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.
Oscar Solans, G Physician principal investigator
Institut Català de la Salut (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of Arterial Pressure in people with Hypertension, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 10 Jan 2014. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of hypertensive patients with criteria for good control of their arterial pressure along one year follow up (time frame: Monitoring of patients for 12 months (from January 1 to December 31, 2010)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2014.