Cardiovascular Risk FactorsNCT01270022
Development, Implementation and Evaluation of the Impact of a Guideline in Clinical Practise for Cardiovascular Risk
A study testing Implementation and dissemination in people with Cardiovascular Risk Factors and Clinical Practice Guideline, run by Gerencia De Atencion Primaria Area 2 De Madrid at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the impact of a clinical guideline in cardiovascular risk, with a local adaptation model of the existing guidelines in clinical practise at present, of each of the different cardiovascular risk factors, and the implementation strategy. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cardiovascular Risk Factors, Clinical Practice Guideline, Implementation Strategies
- What is being tested?
- Implementation and dissemination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Jan 2004to Jul 2010
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients whose health cards showed them to belong to the studied health area
Who cannot join
- Clinical history have not opened in the health center or this one is empty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Implementation and Evaluation of the Impact of a Guideline in Clinical Practise for Cardiovascular Risk.
The aim of this study is to evaluate the impact of a clinical guideline in cardiovascular risk, with a local adaptation model of the existing guidelines in clinical practise at present, of each of the different cardiovascular risk factors, and the implementation strategy.
Read the detailed description
With this objective this study will be developed in three diferent phases. The guideline in clinical practice elaboration. It will be based in evidence medicine and it will be adapted based in the cardiovascular risk factors guidelines published at the present.
The spreding and implementation of the guideline between the sanitarians, as much in primary medicine as in specialised area, involved in the care of the patient in cardiovascular risk, in the Area 2 in Madrid.
And the evaluation of the implementation strategy, used between the primary care physicians.
For the local adaptation, will be used a systematic review of the different guidelines in the Spanish and international literature, published in the last years about this topic.
The ones with better quality criteria will be selected and doctors and nurses related from different specialities, involved in the cardiovascular illness, as much as members of the staff of the medical management an nursery, will be invited to participate in the selection of the recommendations of the guides and in the search of the consensus. After that, this guide will be given to a group of patients, who will be asked for a critical approach and their suggestions will be applied.
The evaluation will be done with a clinical trial designe , testing the use of the guide and its results on health intermediary variables. With this objective the results with an implementation technique based on opinion leaders plus computer reminder, will be evaluated, instead of using the standard implementation.
- Conditions
- Cardiovascular Risk Factors, Clinical Practice Guideline, Implementation Strategies, Primary Care
- Being tested
- Implementation, dissemination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplementationOther
disseminationOther
| Study group | Role | What they receive |
|---|---|---|
| Implementation | Experimental | Not described Receives: Other: Implementation |
| dissemination | Active comparator | Not described Receives: Other: dissemination |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2004
- Primary completionApr 2006
- Study completionJul 2010
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 Cardiovascular Risk FactorsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
Sponsor and investigators
- Lead sponsor
- Gerencia De Atencion Primaria Area 2 De Madrid
- Sponsor type
- Other government
- Collaborators
- Health Research Fund of ISCIII Spain
- Investigators
- Blanca Novella, MD. pHD, Principal investigator, Gerencia de Atención Primaria del área 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270022
- Sponsor's protocol ID
- PI031216
- Status last verified
- Jan 2011
- First submitted
- 4 Jan 2011
- Last updated
- 5 Jan 2011
- Results posted
- No
Publications
Rodriguez-Salvanes F, Novella B, Fernandez Luque MJ, Sanchez-Gomez LM, Ruiz-Diaz L, Sanchez-Alcalde R, Sierra-Garcia B, Mayayo S, Ruiz-Lopez M, Loeches P, Lopez-Gonzalez J, Gonzalez-Gamarra A; SIRVA2 group. Efficacy of a strategy for implementing a guideline for the control of cardiovascular risk in a primary healthcare setting: the SIRVA2 study a controlled, blinded community intervention trial randomised by clusters. BMC Fam Pract. 2011 Apr 19;12:21. doi: 10.1186/1471-2296-12-21.
PubMed 21504570
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation and Evaluation of the Impact of a Guideline in Clinical Practise for Cardiovascular Risk.
- ClinicalTrials.gov ID
- NCT01270022
- Acronym / sponsor ID
- PI031216
- Conditions
- Cardiovascular Risk Factors, Clinical Practice Guideline, Implementation Strategies, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gerencia De Atencion Primaria Area 2 De MadridOther government
- Collaborators
- Health Research Fund of ISCIII Spain
- Study start
- Jan 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Jan 2011 (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 aim of this study is to evaluate the impact of a clinical guideline in cardiovascular risk, with a local adaptation model of the existing guidelines in clinical practise at present, of each of the different cardiovascular risk factors, and the implementation strategy.
Detailed description
With this objective this study will be developed in three diferent phases. The guideline in clinical practice elaboration. It will be based in evidence medicine and it will be adapted based in the cardiovascular risk factors guidelines published at the present.
The spreding and implementation of the guideline between the sanitarians, as much in primary medicine as in specialised area, involved in the care of the patient in cardiovascular risk, in the Area 2 in Madrid.
And the evaluation of the implementation strategy, used between the primary care physicians.
For the local adaptation, will be used a systematic review of the different guidelines in the Spanish and international literature, published in the last years about this topic.
The ones with better quality criteria will be selected and doctors and nurses related from different specialities, involved in the cardiovascular illness, as much as members of the staff of the medical management an nursery, will be invited to participate in the selection of the recommendations of the guides and in the search of the consensus. After that, this guide will be given to a group of patients, who will be asked for a critical approach and their suggestions will be applied.
The evaluation will be done with a clinical trial designe , testing the use of the guide and its results on health intermediary variables. With this objective the results with an implementation technique based on opinion leaders plus computer reminder, will be evaluated, instead of using the standard implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation | Experimental | Other: Implementation |
| dissemination | Active comparator | Other: dissemination |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients whose health cards showed them to belong to the studied health area
Key exclusion criteria (1 listed)
- Clinical history have not opened in the health center or this one is empty
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 |
|---|---|---|
| Implementation | Other | Implementation |
| dissemination | Other | dissemination |
Primary outcome
Not reported in the source record.
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 5 Jan 2011.
- Derived from this study: PubMed 21504570Rodriguez-Salvanes F, Novella B, Fernandez Luque MJ, Sanchez-Gomez LM, Ruiz-Diaz L, Sanchez-Alcalde R, Sierra-Garcia B, Mayayo S, Ruiz-Lopez M, Loeches P, Lopez-Gonzalez J, Gonzalez-Gamarra A; SIRVA2 group. Efficacy of a strategy for implementing a guideline for the control of cardiovascular risk in a primary healthcare setting: the SIRVA2 study a controlled, blinded community intervention trial randomised by clusters. BMC Fam Pract. 2011 Apr 19;12:21. doi: 10.1186/1471-2296-12-21.
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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.
Blanca Novella, MD. pHD principal investigator
Gerencia de Atención Primaria del área 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation and dissemination in people with Cardiovascular Risk Factors and Clinical Practice Guideline, run by Gerencia De Atencion Primaria Area 2 De Madrid 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 1 inclusion and 1 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 5 Jan 2011. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270022, 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 5 Jan 2011.