Effectiveness of Early Detection of Atrial Fibrillation (FAMDAP)
This study is enrolling participants by invitation only.
Sponsor:
Hospital Universitario Reina Sofia
Collaborator:
semFYC
Information provided by:
Hospital Universitario Reina Sofia
ClinicalTrials.gov Identifier:
NCT01291953
First received: February 8, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 8, 2011 | ||||
| Last Updated Date | February 8, 2011 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
efficacy of screening: number of cases diagnosed of Atrial fibrillation (AF) [ Time Frame: one year ] [ Designated as safety issue: Yes ] Risk Relative (RR)=number of cases of AF with the Screening/number of cases of AF with the habitual intervention |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Early Detection of Atrial Fibrillation | ||||
| Official Title ICMJE | Effectiveness of Early Detection of Atrial Fibrillation in People 65 Years or More bt Physicians and Nurse in Primary Care | ||||
| Brief Summary | To verify if the screening opportunistic of Atrial Fibrillation (AF) by means of the measurement of the arterial peripheral pulse is more effective than the habitual practice for the early detection of AF in 65-year-old who come to Primary care |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE | Atrial Fibrillation | ||||
| Intervention ICMJE | Procedure: arterial pulse and electrocardiogram (ECG)
Determination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG
Other Name: case finding |
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| Study Arm (s) | Experimental: screening opportunist
search opportunist will invite patient to realize an ECG, if pulse is irregular
Intervention: Procedure: arterial pulse and electrocardiogram (ECG) |
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| Publications * | Pérula-de-Torres LÁ, Martínez-Adell MÁ, González-Blanco V, Baena-Díez JM, Martín-Rioboó E, Parras-Rejano JM, González-Lama J, Martín-Alvarez R, Ruiz-Moral R, Fernández-García JÁ, Pérez-Díaz M, Ruiz-de-Castroviejo J, Pérula-de-Torres C, Valero-Martín A, Roldán-Villalobos A, Criado-Larumbe M, Burdoy-Joaquín E, Coma-Solé M, Cervera-León M, Cuixart-Costa L; Collaborative Group DOFA-AP. Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol. BMC Fam Pract. 2012 Oct 30;13:106. doi: 10.1186/1471-2296-13-106. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 12870 | ||||
| Estimated Completion Date | June 2012 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01291953 | ||||
| Other Study ID Numbers ICMJE | PI-0419-2010 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Luis A Pérula, Andalusian Health Service | ||||
| Study Sponsor ICMJE | Hospital Universitario Reina Sofia | ||||
| Collaborators ICMJE | semFYC | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital Universitario Reina Sofia | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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