Atrial Fibrillation Screening and Education Study
Evaluation of a Community-Placed Atrial Fibrillation Screening and Education Program
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Background/significance: Atrial fibrillation (AF) is a global epidemic that accounts for 15%-20% of 795,000 strokes occurring annually in the US, at a cost of $3.2 billion per year. Atrial fibrillation-related stroke will rise with the aging population and places enormous strain on healthcare resources and quality of life; yet they are highly preventable, by early detection of AF. Timely treatment reduces AF-related stroke risk by 68%, yet treatment is often delayed because people may not recognize the symptoms of AF or may be asymptomatic. Given the number of people at risk for development of AF and the dire consequences of untreated AF, efforts to promote early detection of AF through proactive screening of older adults at risk for AF have been successfully undertaken in Europe and Australia. However, little is known about the outcomes of conducting programs to screen for and educate people about AF in community settings in the US.
Purpose: The purpose of this descriptive pragmatic study to evaluate the outcomes of a community placed AF screening and education program. Primary outcomes include feasibility, number of participants who screen positive for AF, and changes in participants' Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Self-Monitoring (KABAF-SM) scores from baseline to two-weeks after enrollment.
Methods: Up to 250-participants who have at least two risk factors for developing AF and have no previous diagnosis of AF will be recruited from Midwest community settings and will be screened for AF using a mobile ECG recorder and will receive written information sheet about AF. A portion (up to 125) of those 250 participants will be invited to complete the KABAF-SM at baseline and 2-weeks after enrollment. Participants will have the option to participate in a variety of AF educational activities to reinforce and enhance the written information. Participants will be surveyed about their perceptions of the educational program after the screening and participating in the educational activities.
Evaluation methods: Descriptive statistics will be used to analyze feasibility (enrollment numbers, participants perception of the value of the educational activities, time required for study procedures,and AF detection.T-tests will be used to test for differences between KABAF-SM baseline and two-week scores for those who completed the KABAF-SM.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Minnesota
-
Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic in Rochester
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion :
Any two of the following:
- Hypertension
- Diabetes
- Sleep apnea
- Obesity
- Age > 75 years
- Peripheral arterial disease
- Female
Exclusion :
- Previous diagnosis of atrial fibrillation or atrial flutter
- Uncompensated visual impairment
- Uncompensated hearing impairment
- Inability to communicate verbally in English
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: AF awareness education
AF awareness education face to face
|
Participants will receive education about a description of AF, complications, recognition of signs and symptoms of AF, pulse taking, and how to recognize an irregular pulse
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility-number enrolled
Zeitfenster: 5 months
|
number of participants enrolled
|
5 months
|
|
Feasibility-time required for study procedure
Zeitfenster: 5 months
|
Number of minutes require to perform mobile ECG
|
5 months
|
|
Participants' perception of the usefulness of the Learning Station activities
Zeitfenster: 5 months
|
The outcome will be measured by the Participant Perception of Learning Station Activities survey.
This survey is an investigator developed 9-item Survey that asks participants to rate how useful learning activities were to increase their knowledge about atrial fibrillation and to what extent their knowledge about atrial fibrillation has increased after participating in the Learning Station activities.
Psychometric testing has not been performed on this survey.
|
5 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in knowledge attitude, and beliefs scores about AF self monitoring from baseline
Zeitfenster: 5 months
|
Knowledge, attitudes, beliefs about self-monitoring for AF signs and symptoms will be measured by the Knowledge Attitudes and Beliefs about Atrial Fibrillation Self-Monitoring (KABAF-SM) instrument.The KABAF-SM is a 40-item instrument that measures knowledge of AF symptoms (8 items yes/no response, score range 0-8); symptoms not related to AF (6 items yes/no response, score range 0-6); and Likert- responses items (strongly disagree-1 to strongly agree-4) for beliefs about the participant's risk for developing AF(5 items), seriousness of AF,(4 items) benefits (5 items), and barriers (5 items) to monitoring for signs and symptoms of AF.
Total score range for the Likert items is 14-56.
Perceived confidence is measured by 7 items, rated from 0-10 (score range, 0-70) for ability to self-monitor for signs and symptoms of AF.
Higher scores reflect more knowledge and more accurate beliefs and positive attitudes toward self-monitoring.
|
5 months
|
|
Number of cases of atrial fibrillation detected with portable ECG
Zeitfenster: 5 months
|
The Alive Cor portable ECG recorder will be used to detect atrial fibrillation.
The device displays the participants rhythm as normal sinus, possible or probable atrial fibrillation, or unable to analyze
|
5 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Pamela J McCabe, Mayo Clinic
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 17-005031
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Vorhofflimmern
-
Institut universitaire de cardiologie et de pneumologie...Anmeldung auf EinladungIdiopathisches Kammerflimmern | Kurzgekoppelte ventrikuläre FibrillationKanada
-
IRCCS Policlinico S. MatteoUniversity of Pavia; Azienda Regionale Emergenza Urgenza (AREU)RekrutierungAußerklinischer Herzstillstand | Ventrikuläre Fibrillation anhaltendItalien
-
Wake Forest University Health SciencesRekrutierungVorhofflimmern | Tachykardie atrial | Vorhofflattern mit schneller ventrikulärer ReaktionVereinigte Staaten
-
Biotronik SE & Co. KGAbgeschlossenVorhofflimmern | Bradykardie | Synkope | Kryptogener Schlaganfall | Tachykardie atrialItalien
-
Edgar JaeggiLabatt Family Heart CentreAbgeschlossenVorhofflattern | Tachykardie, supraventrikulär | Tachykardie, AV-Knoten-Wiedereintritt | Tachykardie atrial | Tachykardie, reziprok | Tachykardie, paroxysmal | Fetaler Hydrops | Tachykardie, atriale EktopieVereinigte Staaten, Vereinigtes Königreich, Kanada, Hongkong, Niederlande, Tschechien, Schweden, Australien, Brasilien, Finnland, Frankreich, Russische Föderation, Spanien, Schweiz
Klinische Studien zur AF awareness education
-
Hacettepe UniversityAssistant Professor Onur İNCE; Associate Professor Dr. Çiğdem YÜCEL ÖZÇIRPANNoch keine RekrutierungUnfruchtbarkeit, weiblichTürkei (türkiye)
-
Vanderbilt UniversityNational Institute of Mental Health (NIMH); University of California, Los Angeles und andere MitarbeiterAbgeschlossenAchtsamkeitVereinigte Staaten
-
Children's Hospital Medical Center, CincinnatiChildren's National Research Institute; Uganda Heart InstituteAbgeschlossenRheumatische HerzerkrankungenUganda
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)AbgeschlossenDepression | Prävention schädlicher Wirkungen | Jugendlicher - Emotionales ProblemVereinigte Staaten
-
Icahn School of Medicine at Mount SinaiUniversity of Florida; Florida International University; Citrus Health Network...Abgeschlossen
-
Ohio State UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... und andere MitarbeiterRekrutierungLeseschwierigkeitenVereinigte Staaten
-
Yale UniversityNational Institute on Drug Abuse (NIDA)AbgeschlossenSteigerung der Therapietreue bei gleichzeitig auftretenden psychiatrischen und DrogenkonsumstörungenStörungen des Drogenkonsums | Psychiatrische Diagnose | Diagnose, dual (Psychiatrie)Vereinigte Staaten
-
Linkoeping UniversityAbgeschlossenDepressive Symptome | Krebs im Kindesalter | Angststörungen und Symptome | Problem der psychischen GesundheitSchweden
-
Wayne State UniversityAbgeschlossen