Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT01721005
Status:
UNKNOWN
Last Update Posted:
2014-05-08
First Post:
2012-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-07', 'studyFirstSubmitDate': '2012-10-26', 'studyFirstSubmitQcDate': '2012-11-01', 'lastUpdatePostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life', 'timeFrame': '1 year followup visit', 'description': 'EQ5D based evaluation'}, {'measure': 'New atrial fibrillation at long-term followup', 'timeFrame': '5 year control', 'description': 'Data on atrial fibrillation and thromboembolic complications is gathered from patient records and patient interview'}], 'primaryOutcomes': [{'measure': 'The willingness to the pulse palpation and competence independently learn to feel own pulse.', 'timeFrame': '1 month control visit', 'description': "Based on learning session evaluated by nurse and objective evaluation of the learned skills by pulse-arm device and patient's pulse diary"}], 'secondaryOutcomes': [{'measure': 'Number of patients with new atrial fibrillation detected during the study', 'timeFrame': 'At 1 year followup', 'description': 'During the 1 year followup visit information on atrial fibrillation is gathered form the patients records and by interview'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'thromboembolism', 'patient education'], 'conditions': ['Atrial Fibrillation', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '28915862', 'type': 'DERIVED', 'citation': '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': '23780517', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nPrevalence 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.\n\nThe 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.\n\nThe study contains two office visits with specified learning session and long-term phone-call follow-up.", 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient aged 75 or over\n* inhabitant of Lieto\n* willing to participate\n\nExclusion Criteria:\n\n* chronic atrial fibrillation\n* ongoing anticoagulant treatment\n* permanent institutional care'}, 'identificationModule': {'nctId': 'NCT01721005', 'acronym': 'LietoAF', 'briefTitle': 'Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto', 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': 'Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto', 'orgStudyIdInfo': {'id': 'T31/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'pulse palpation education', 'description': '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', 'interventionNames': ['Other: Subject education to pulse palpation']}], 'interventions': [{'name': 'Subject education to pulse palpation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['pulse palpation education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21420', 'city': 'Lieto', 'country': 'Finland', 'facility': 'Härkätie community health center', 'geoPoint': {'lat': 60.51032, 'lon': 22.46176}}], 'overallOfficials': [{'name': 'Juhani K Airaksinen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Turku'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Juhani Airaksinen', 'investigatorAffiliation': 'University of Turku'}}}}