- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Lieto, Finlandia, 21420
- Härkätie community health center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patient aged 75 or over
- inhabitant of Lieto
- willing to participate
Exclusion Criteria:
- chronic atrial fibrillation
- ongoing anticoagulant treatment
- permanent institutional care
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The willingness to the pulse palpation and competence independently learn to feel own pulse.
Periodo de tiempo: 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
|
1 month control visit
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of patients with new atrial fibrillation detected during the study
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of life
Periodo de tiempo: 1 year followup visit
|
EQ5D based evaluation
|
1 year followup visit
|
|
New atrial fibrillation at long-term followup
Periodo de tiempo: 5 year control
|
Data on atrial fibrillation and thromboembolic complications is gathered from patient records and patient interview
|
5 year control
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Juhani K Airaksinen, Professor, University of Turku
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- T31/2012
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .