Atrial FibrillationLietoAFNCT01721005
Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto
A study testing Subject education to pulse palpation in people with Atrial Fibrillation and Stroke, run by University of Turku at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Subject education to pulse palpation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- patient aged 75 or over
- inhabitant of Lieto
- willing to participate
Who cannot join
- chronic atrial fibrillation
- ongoing anticoagulant treatment
- permanent institutional care
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Subject education to pulse palpation
- Keywords
- atrial fibrillation, thromboembolism, patient education
- Medical subject headings
- Atrial Fibrillation, Stroke, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Subject education to pulse palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month control visit
Secondary outcomes (1)
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
Measured: At 1 year followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhani Airaksinen, University of Turku
- Investigators
- Juhani K Airaksinen, Professor, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721005
- Sponsor's protocol ID
- T31/2012
- Acronym
- LietoAF
- Status last verified
- May 2014
- First submitted
- 26 Oct 2012
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28915862Virtanen 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.
PubMed 23780517
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto
- ClinicalTrials.gov ID
- NCT01721005
- Acronym / sponsor ID
- LietoAF / T31/2012
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- atrial fibrillation, thromboembolism, patient education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulse palpation education | Other | Other: Subject education to pulse palpationThe subject is educated to pulse palpation by registered cardiac nurse. The education time is limited to 10 minutes and done according preplanned education model |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patient aged 75 or over
- inhabitant of Lieto
- willing to participate
Key exclusion criteria (3 listed)
- chronic atrial fibrillation
- ongoing anticoagulant treatment
- permanent institutional care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subject education to pulse palpationThe 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 | pulse palpation education |
Primary outcome
The willingness to the pulse palpation and competence independently learn to feel own pulse.
Time frame: 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 secondary outcome
Number of patients with new atrial fibrillation detected during the study
Time frame: At 1 year followup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Derived from this study: PubMed 28915862Jaakkola 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.
- Derived from this study: PubMed 23780517Virtanen 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juhani K Airaksinen, Professor principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subject education to pulse palpation in people with Atrial Fibrillation and Stroke, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The willingness to the pulse palpation and competence independently learn to feel own pulse. (time frame: 1 month control visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721005, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.