HypertensionINCOTECANCT00820183
A Quality Improvement Plan for Hypertension Control
A study of Hypertension, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The study hypothesis is that the implementation of a plan for quality improvement at the primary care health teams taking care of hypertensive patients, will increase the level of blood pressure control among those patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34,327 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2006to Apr 2008
- 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 diagnosed with hypertension before January 1st, 2006
- Patients assigned at the primary health team participating, and with clinical electronic records
Who cannot join
- Patients diagnosed with hypertension after January 1st, 2006
- Patients under 18 years of age
- Patients with a diastolic blood pressure higher than systolic blood pressure as recorded in the clinical records
Trial locations and contacts
1 site in 1 country.
Spain1 site
SAP Cerdanyola-Ripollet Institut Català de la Salut
Cerdanyola del Vallès, Barcelona
About this study
Official title: A Quality Improvement Plan for Hypertension Control: the INCOTECA Project
The study hypothesis is that the implementation of a plan for quality improvement at the primary care health teams taking care of hypertensive patients, will increase the level of blood pressure control among those patients.
Read the detailed description
The study is to compare the results on the hypertension control between two groups of primary health care teams. The intervention group will undertake a quality improvement plan for hypertension control, in which the following aspects will be included in the intervention:
Specific training programme on how to diagnose hypertension , and measure blood pressure correctly To send feed back information to primary care health professionals about poorly controlled hypertensive patients An audit will be performed, every 6 months, to see the adhesion to the recommended clinical guidelines , and the information will be diffused among the participant primary health care professionals Each participant primary health care team will have a designated reference person, that will provide support on any doubts on the programme implementation.
The non intervention group will follow hypertensive patients following the same clinical practice guide as the intervention group, with no intervention on the primary health care professionals
- Conditions
- Hypertension
- Being tested
- Quality Improvement plan for Hypertension Control
- Keywords
- Hypertension, Intervention, Primary Care, Quality improvement
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement plan for Hypertension ControlOther
Implementation of a plan of quality improvement addressed to health professionals in Primary Health Care Teams. It includes:
Specific training programme on how to diagnose hypertension , and measure blood pressure correctly To send feed back information to primary care health professionals about poorly controlled hypertensive patients An audit will be performed, every 6 months, to see the adhesion to the recommended clinical guidelines , and the information will be diffused among the participant primary health care professionals Each participant primary health care team will have a designated reference person, that will provide support on any doubts on the programme implementation
| Study group | Role | What they receive |
|---|---|---|
| quality improvement plan | Experimental | It will be the group of primary health care teams who will undertake the quality improvement plan for hypertensive patients Receives: Other: Quality Improvement plan for Hypertension Control |
| non intervention | No intervention | It will be the group of primary health care teams that will not undertake the quality improvement plan for hypertension control |
What is being measured
The primary outcome is the main question the study is designed to answer.
good control of hypertension as a dichotomous variable, based on systolic blood pressure and diastolic blood pressure records over the last 12 months
Measured: every three months, for a whole year
Secondary outcomes (1)
treatment with antihypertensive drugs, number of antihypertensive drugs, assessment of therapeutic compliance
Measured: every three months, for a whole year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startFeb 2006
- Primary completionApr 2007
- Study completionApr 2008
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34,327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Investigators
- Roser Valles Fernandez, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820183
- Sponsor's protocol ID
- RSB_2006
- Acronym
- INCOTECA
- Status last verified
- Jan 2009
- First submitted
- 9 Jan 2009
- Last updated
- 7 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality Improvement Plan for Hypertension Control: the INCOTECA Project
- ClinicalTrials.gov ID
- NCT00820183
- Acronym / sponsor ID
- INCOTECA / RSB_2006
- Conditions
- Hypertension
- Keywords
- Hypertension, Intervention, Primary Care, Quality improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34,327 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Jan 2009 (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 study hypothesis is that the implementation of a plan for quality improvement at the primary care health teams taking care of hypertensive patients, will increase the level of blood pressure control among those patients.
Detailed description
The study is to compare the results on the hypertension control between two groups of primary health care teams. The intervention group will undertake a quality improvement plan for hypertension control, in which the following aspects will be included in the intervention:
Specific training programme on how to diagnose hypertension , and measure blood pressure correctly To send feed back information to primary care health professionals about poorly controlled hypertensive patients An audit will be performed, every 6 months, to see the adhesion to the recommended clinical guidelines , and the information will be diffused among the participant primary health care professionals Each participant primary health care team will have a designated reference person, that will provide support on any doubts on the programme implementation.
The non intervention group will follow hypertensive patients following the same clinical practice guide as the intervention group, with no intervention on the primary health care professionals
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quality improvement plan | Experimental | Other: Quality Improvement plan for Hypertension ControlIt will be the group of primary health care teams who will undertake the quality improvement plan for hypertensive patients |
| non intervention | No intervention | –It will be the group of primary health care teams that will not undertake the quality improvement plan for hypertension control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with hypertension before January 1st, 2006
- Patients assigned at the primary health team participating, and with clinical electronic records
Key exclusion criteria (3 listed)
- Patients diagnosed with hypertension after January 1st, 2006
- Patients under 18 years of age
- Patients with a diastolic blood pressure higher than systolic blood pressure as recorded in the clinical records
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 |
|---|---|---|
| Quality Improvement plan for Hypertension ControlImplementation of a plan of quality improvement addressed to health professionals in Primary Health Care Teams. It includes: Specific training programme on how to diagnose hypertension , and measure blood pressure correctly To send feed back information to primary care health professionals about poorly controlled hypertensive patients An audit will be performed, every 6 months, to see the adhesion to the recommended clinical guidelines , and the information will be diffused among the participant primary health care professionals Each participant primary health care team will have a designated reference person, that will provide support on any doubts on the programme implementation | Other | quality improvement plan |
Primary outcome
good control of hypertension as a dichotomous variable, based on systolic blood pressure and diastolic blood pressure records over the last 12 months
Time frame: every three months, for a whole year
1 secondary outcome
treatment with antihypertensive drugs, number of antihypertensive drugs, assessment of therapeutic compliance
Time frame: every three months, for a whole year
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 7 May 2009.
- describes de procedures to follow management and treatment of hypertensive patients in the study protocolLink provided by the sponsor.
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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.
Roser Valles Fernandez principal investigator
Institut Català de la Salut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 2 inclusion and 3 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 7 May 2009. 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?
good control of hypertension as a dichotomous variable, based on systolic blood pressure and diastolic blood pressure records over the last 12 months (time frame: every three months, for a whole year). 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 7 May 2009.