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- Klinische proef NCT01721005
Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto (LietoAF)
The aim of this study is to evaluate the feasibility of patient education on feeling the own pulse irregularity in the elderly population of Lieto.
Prevalence of atrial fibrillation (AF) rises with age. Subjects have often symptoms like palpitation and discomfort but especially in elderly population there's significant quantity of persons who don't feel any symptoms and fail to seek for medical care for stroke prevention.
The main objectives in this study are to find out the prevalence of AF in the elderly population of Lieto, to assess the feasibility and reability of patient education on feeling one's pulse irregularity and the affect to the quality of life of the participating subjects and monitoring the possible increased burden to the public health care system.
The study contains two office visits with specified learning session and long-term phone-call follow-up.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The main objectives in this study are to find out the prevalence of AF in the elderly population of Lieto, to assess the feasibility of patient education on feeling one's pulse irregularity and the affect to the quality of life of the participating subjects and monitoring the possible increased burden to the public health care system.
The study contains two office visits with specified learning session and long-term phone-call follow-up. A specially trained nurse will initially give a 10 min education on pulse palpation to each person and evaluate their capacity to learn pulse palpation. During followup visits the compliance of the patient and possible new arrhythmias plus quality of life issues are recorded and their ability of pulse palpation is evaluated by artificial hand where various kinds of pulses are transmitted.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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-
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Lieto, Finland, 21420
- Härkätie community health center
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- patient aged 75 or over
- inhabitant of Lieto
- willing to participate
Exclusion Criteria:
- chronic atrial fibrillation
- ongoing anticoagulant treatment
- permanent institutional care
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: pulse palpation education
The subject is educated to pulse palpation by registered cardiac nurse.
The education time is limited to 10 minutes and done according preplanned education model
|
The subject is educated to pulse palpation by registered cardiac nurse.
The education time is limited to 10 minutes and done according preplanned education model.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The willingness to the pulse palpation and competence independently learn to feel own pulse.
Tijdsspanne: 1 month control visit
|
Based on learning session evaluated by nurse and objective evaluation of the learned skills by pulse-arm device and patient's pulse diary
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1 month control visit
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of patients with new atrial fibrillation detected during the study
Tijdsspanne: At 1 year followup
|
During the 1 year followup visit information on atrial fibrillation is gathered form the patients records and by interview
|
At 1 year followup
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quality of life
Tijdsspanne: 1 year followup visit
|
EQ5D based evaluation
|
1 year followup visit
|
|
New atrial fibrillation at long-term followup
Tijdsspanne: 5 year control
|
Data on atrial fibrillation and thromboembolic complications is gathered from patient records and patient interview
|
5 year control
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Juhani K Airaksinen, Professor, University of Turku
Publicaties en nuttige links
Algemene publicaties
- Jaakkola J, Virtanen R, Vasankari T, Salminen M, Airaksinen KEJ. Self-detection of atrial fibrillation in an aged population: three-year follow-up of the LietoAF intervention study. BMC Geriatr. 2017 Sep 16;17(1):218. doi: 10.1186/s12877-017-0607-0.
- Virtanen R, Kryssi V, Vasankari T, Salminen M, Kivela SL, Airaksinen KE. Self-detection of atrial fibrillation in an aged population: the LietoAF Study. Eur J Prev Cardiol. 2014 Nov;21(11):1437-42. doi: 10.1177/2047487313494041. Epub 2013 Jun 18.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- T31/2012
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