Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto (LietoAF)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01721005 |
|
Recruitment Status : Unknown
Verified May 2014 by Juhani Airaksinen, University of Turku.
Recruitment status was: Active, not recruiting
First Posted : November 2, 2012
Last Update Posted : May 8, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation Stroke | Other: Subject education to pulse palpation | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 200 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto |
| Study Start Date : | April 2012 |
| Estimated Primary Completion Date : | November 2016 |
| Estimated Study Completion Date : | December 2017 |
| Arm | Intervention/treatment |
|---|---|
|
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
|
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. |
- 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
- Number of patients with new atrial fibrillation detected during the study [ Time Frame: At 1 year followup ]During the 1 year followup visit information on atrial fibrillation is gathered form the patients records and by interview
- Quality of life [ Time Frame: 1 year followup visit ]EQ5D based evaluation
- New atrial fibrillation at long-term followup [ Time Frame: 5 year control ]Data on atrial fibrillation and thromboembolic complications is gathered from patient records and patient interview
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 75 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- patient aged 75 or over
- inhabitant of Lieto
- willing to participate
Exclusion Criteria:
- chronic atrial fibrillation
- ongoing anticoagulant treatment
- permanent institutional care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721005
| Finland | |
| Härkätie community health center | |
| Lieto, Finland, 21420 | |
| Principal Investigator: | Juhani K Airaksinen, Professor | University of Turku |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Juhani Airaksinen, Professor, University of Turku |
| ClinicalTrials.gov Identifier: | NCT01721005 History of Changes |
| Other Study ID Numbers: |
T31/2012 |
| First Posted: | November 2, 2012 Key Record Dates |
| Last Update Posted: | May 8, 2014 |
| Last Verified: | May 2014 |
Keywords provided by Juhani Airaksinen, University of Turku:
|
atrial fibrillation thromboembolism patient education |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |