Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto

Stroke Clinical Trial

— LietoAF  

Official title:

Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01721005
• Other study ID #: T31/2012
• Status: Active, not recruiting
• Phase: N/A
• First received: October 26, 2012
• Last updated: May 7, 2014
• Start date: April 2012
• Est. completion date: December 2017

Study information

• Verified date: May 2014
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Advisory Board on Health Care Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• patient aged 75 or over

• inhabitant of Lieto

• willing to participate

Exclusion Criteria:

• chronic atrial fibrillation

• ongoing anticoagulant treatment

• permanent institutional care

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Other:
• Subject education to pulse palpation
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.

Locations

Country	Name	City	State
Finland	Härkätie community health center	Lieto

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	EQ5D based evaluation	1 year followup visit	No
Other	New atrial fibrillation at long-term followup	Data on atrial fibrillation and thromboembolic complications is gathered from patient records and patient interview	5 year control	No
Primary	The willingness to the pulse palpation and competence independently learn to feel own pulse.	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	No
Secondary	Number of patients with new atrial fibrillation detected during the study	During the 1 year followup visit information on atrial fibrillation is gathered form the patients records and by interview	At 1 year followup	No