Back to resultsEffectiveness of Early Detection of Atrial Fibrillation (FAMDAP)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Screening
Control
Sponsored by
About this trial
This is an interventional screening trial for Atrial Fibrillation focused on measuring atrial fibrillation, screening, prevention, case finding, primary care
Eligibility Criteria
Inclusion Criteria:
Patients that come to his center of health for any motive.
- That give his assent informed to take part in the study.
Exclusion Criteria:
- FA previous Diagnosis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Screening
Control
Arm Description
Opportunist Screening asymptomatic patients. Taking the arterial pulse. Will invite patient to realize an ECG, if pulse is irregular
Case finding of patient whith symptoms of atrial fibrilation. Taking the arterial pulse. ECG if pulse is irregular
Outcomes
Primary Outcome Measures
efficacy of screening: number of cases diagnosed of Atrial fibrillation (AF)
Risk Relative (RR)=number of cases of AF with the Screening/number of cases of AF with the habitual intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT01291953
First Posted
February 8, 2011
Last Updated
August 17, 2015
Sponsor
Hospital Universitario Reina Sofia de Cordoba
Collaborators
Spanish Society of Family and Community Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01291953
Brief Title
Effectiveness of Early Detection of Atrial Fibrillation
Acronym
FAMDAP
Official Title
Effectiveness of Early Detection of Atrial Fibrillation in People 65 Years or More bt Physicians and Nurse in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Reina Sofia de Cordoba
Collaborators
Spanish Society of Family and Community Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, screening, prevention, case finding, primary care
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6990 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screening
Arm Type
Experimental
Arm Description
Opportunist Screening asymptomatic patients. Taking the arterial pulse. Will invite patient to realize an ECG, if pulse is irregular
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Case finding of patient whith symptoms of atrial fibrilation. Taking the arterial pulse. ECG if pulse is irregular
Intervention Type
Procedure
Intervention Name(s)
Screening
Other Intervention Name(s)
Asymptomatic patient
Intervention Description
Determination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG
Intervention Type
Procedure
Intervention Name(s)
Control
Other Intervention Name(s)
Symptomatic patient
Intervention Description
Determination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG
Primary Outcome Measure Information:
Title
efficacy of screening: number of cases diagnosed of Atrial fibrillation (AF)
Description
Risk Relative (RR)=number of cases of AF with the Screening/number of cases of AF with the habitual intervention
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients that come to his center of health for any motive.
That give his assent informed to take part in the study.
Exclusion Criteria:
FA previous Diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis A Perula, PhD
Organizational Affiliation
Andalusian Health Service
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
28196583
Citation
Gonzalez Blanco V, Perula de Torres LA, Martin Rioboo E, Martinez Adell MA, Parras Rejano JM, Gonzalez Lama J, Ruiz Moruno J, Martin Alvarez R, Fernandez Garcia JA, Ruiz de Castroviejo J, Roldan Villalobos A, Ruiz Moral R; grupo de estudio colaborativo DOFA-AP. Opportunistic screening for atrial fibrillation versus detecting symptomatic patients aged 65 years and older: A cluster-controlled clinical trial. Med Clin (Barc). 2017 Jan 6;148(1):8-15. doi: 10.1016/j.medcli.2016.07.036. Epub 2016 Oct 26. English, Spanish.
Results Reference
derived
PubMed Identifier
23130754
Citation
Perula-de-Torres LA, Martinez-Adell MA, Gonzalez-Blanco V, Baena-Diez JM, Martin-Rioboo E, Parras-Rejano JM, Gonzalez-Lama J, Martin-Alvarez R, Ruiz-Moral R, Fernandez-Garcia JA, Perez-Diaz M, Ruiz-de-Castroviejo J, Perula-de-Torres C, Valero-Martin A, Roldan-Villalobos A, Criado-Larumbe M, Burdoy-Joaquin E, Coma-Sole M, Cervera-Leon 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.
Results Reference
derived
Links:
URL
http://www.biomedcentral.com/1471-2296/13/106
Description
Study protocol
Learn more about this trial
Effectiveness of Early Detection of Atrial Fibrillation
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