NCT01721005

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

4.6 years

First QC Date

October 26, 2012

Last Update Submit

May 7, 2014

Conditions

Atrial FibrillationStroke

Keywords

atrial fibrillationthromboembolismpatient education

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of patients with new atrial fibrillation detected during the study

    At 1 year followup

Other Outcomes (2)

  • Quality of life

    1 year followup visit

  • New atrial fibrillation at long-term followup

    5 year control

Study Arms (1)

pulse palpation education

OTHER

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

Other: Subject education to pulse palpation

Interventions

Subject education to pulse palpationOTHER

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.

pulse palpation education

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • patient aged 75 or over
  • inhabitant of Lieto
  • willing to participate

You may not qualify if:

  • chronic atrial fibrillation
  • ongoing anticoagulant treatment
  • permanent institutional care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Härkätie community health center

Lieto, 21420, Finland

Location

Related Publications (2)

  • 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.

    PMID: 28915862DERIVED

  • 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.

    PMID: 23780517DERIVED

MeSH Terms

Conditions

Atrial FibrillationStrokeThromboembolism

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesEmbolism and Thrombosis

Study Officials

  • Juhani K Airaksinen, Professor

    University of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2012

First Posted

November 2, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2016

Study Completion

December 1, 2017

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

FI(1)