HypertensionAFenPANCT01233193
The Effect of Pharmacist Intervention on Blood Pressure Control
A study testing Health education, Home blood pressure monitoring in people with Hypertension, run by Universidad de Granada at 2 sites in Spain.
Trial summary
The purpose of the study is to test if a Pharmacist Intervention Program with home blood pressure monitoring (HBPM) improves or controls pharmacological adherence and blood pressure levels in hypertensive patients under pharmacological treatment, compared to those who receive usual care in a community pharmacy setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Health education, Home blood pressure monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSpain
- Study dates
- Feb 2010to Sep 2011
- 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
- Patients of both genders between the ages of 18 and 80 years, who access the pharmacy to fill their own prescription for hypertension.
Who cannot join
- Patient living with an other Hypertensive patient treated with the same medications
- Pregnant women
- Hypertensive patients with levels of systolic/diastolic blood pressure ≥ 180mmHg/110mmHg
- Patient with secondary hypertension, kidney or liver failure
- Patients already included in a care program for hypertensive patients
- Patients with a new treatment for hypertension (less than 1 month)
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Community Pharmacies
Granada, Andalusia, 18000
Community Pharmacies
Jaén, Andalusia, 23000
About this study
Official title: Pharmacist Intervention Effect on the Medication Adherence and Blood Pressure Control in Treated Patients
The purpose of the study is to test if a Pharmacist Intervention Program with home blood pressure monitoring (HBPM) improves or controls pharmacological adherence and blood pressure levels in hypertensive patients under pharmacological treatment, compared to those who receive usual care in a community pharmacy setting.
Read the detailed description
Hypertension is a major health concern worldwide due to its deleterious impact on the population in terms of excessive morbidity and mortality, especially when there is insufficient hypertension control and prevention at the community level.
- Conditions
- Hypertension
- Being tested
- Health education, Home blood pressure monitoring
- Keywords
- Home blood pressure measurement, Pharmaceutical Services, Medication adherence, hypertension management, Blood Pressure
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education, Home blood pressure monitoringBehavioural
Also called pharmaceutical health education
Health education (on hypertension, smoking, healthy diet, obesity, physical inactivity and adherence to antihypertensive medications and home blood pressure monitoring) . The patient will be referred to physician when needed. The patient will be followed up during 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group receive an pharmacist intervention (health education, Home Blood Pressure Monitoring and Referral to physician as needed) This group will be followed for 6 months Receives: Behavioral: Health education, Home blood pressure monitoring |
| Control | No intervention | The control group receive usual care in the community pharmacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure control
Percentage of patients with controlled hypertension
Measured: At 6 months
Secondary outcomes (1)
Adherence
Percentage of adherent patients after 6 months within the trial
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Investigators
- Maria Jose Faus, PhD, Study director, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233193
- Sponsor's protocol ID
- DMM01-FAR-10
- Acronym
- AFenPA
- Status last verified
- Feb 2010
- First submitted
- 29 Oct 2010
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Intervention Effect on the Medication Adherence and Blood Pressure Control in Treated Patients
- ClinicalTrials.gov ID
- NCT01233193
- Acronym / sponsor ID
- AFenPA / DMM01-FAR-10
- Conditions
- Hypertension
- Keywords
- Home blood pressure measurement, Pharmaceutical Services, Medication adherence, hypertension management, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 3 Nov 2010 (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.
The purpose of the study is to test if a Pharmacist Intervention Program with home blood pressure monitoring (HBPM) improves or controls pharmacological adherence and blood pressure levels in hypertensive patients under pharmacological treatment, compared to those who receive usual care in a community pharmacy setting.
Detailed description
Hypertension is a major health concern worldwide due to its deleterious impact on the population in terms of excessive morbidity and mortality, especially when there is insufficient hypertension control and prevention at the community level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health education, Home blood pressure monitoringThe intervention group receive an pharmacist intervention (health education, Home Blood Pressure Monitoring and Referral to physician as needed) This group will be followed for 6 months |
| Control | No intervention | –The control group receive usual care in the community pharmacy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both genders between the ages of 18 and 80 years, who access the pharmacy to fill their own prescription for hypertension.
Key exclusion criteria (6 listed)
- Patient living with an other Hypertensive patient treated with the same medications
- Pregnant women
- Hypertensive patients with levels of systolic/diastolic blood pressure ≥ 180mmHg/110mmHg
- Patient with secondary hypertension, kidney or liver failure
- Patients already included in a care program for hypertensive 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 |
|---|---|---|
| Health education, Home blood pressure monitoringAlso: pharmaceutical health educationHealth education (on hypertension, smoking, healthy diet, obesity, physical inactivity and adherence to antihypertensive medications and home blood pressure monitoring) . The patient will be referred to physician when needed. The patient will be followed up during 6 months. | Behavioural | Intervention |
Primary outcome
blood pressure control
Time frame: At 6 months
Percentage of patients with controlled hypertension
1 secondary outcome
Adherence
Time frame: At 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
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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.
Maria Jose Faus, PhD study director
Universidad de Granada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education, Home blood pressure monitoring in people with Hypertension, run by Universidad de Granada at 2 sites 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 1 inclusion and 6 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 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
blood pressure control (time frame: At 6 months). 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 6 May 2016.