Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-01-03 @ 7:40 PM
Study NCT ID:
NCT03384732
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of an ICF Core Set for Geriatric Patients in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Most common health issues of community-dwelling elderly reported in scientific literature (systematic literature review)', 'timeFrame': '07/2017-10/2018', 'description': "The primary outcome will be a core set containing relevant ICF categories from the researchers' perspective."}, {'measure': 'ADL abilities and disabilities of community-dwelling elderly reported by community-dwelling elderly in semi-structured interviews and focus groups (qualitative study)', 'timeFrame': '06/2017-01/2018', 'description': "The primary outcome will be a core set containing relevant ICF categories from the patients' perspective."}, {'measure': 'ADL abilities and disabilities of community-dwelling elderly reported by experts in an online survey (expert survey)', 'timeFrame': '06/2018-04/2019', 'description': "The primary outcome will be a core set containing relevant ICF categories from the experts' perspective."}, {'measure': 'Most common health issues of community-dwelling elderly assessed by the extended ICF checklist (empirical multicenter study)', 'timeFrame': '04/2018-09/2018', 'description': 'The primary outcome will be a core set containing relevant ICF categories from the clinical perspective.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['community-dwelling elderly', 'ICF', 'core set development', 'geriatric', 'functioning', 'health', 'ageing'], 'conditions': ['Old and Very Old People', 'Independent Living', 'Functioning']}, 'referencesModule': {'references': [{'pmid': '24686893', 'type': 'BACKGROUND', 'citation': 'Selb M, Escorpizo R, Kostanjsek N, Stucki G, Ustun B, Cieza A. A guide on how to develop an International Classification of Functioning, Disability and Health Core Set. Eur J Phys Rehabil Med. 2015 Feb;51(1):105-17. Epub 2014 Apr 1.'}, {'pmid': '33597130', 'type': 'DERIVED', 'citation': 'Tomandl J, Heinmuller S, Selb M, Graessel E, Freiberger E, Kuhlein T, Hueber S, Book S, Gotthardt S. Laying the foundation for a Core Set of the International Classification of Functioning, Disability and Health for community-dwelling older adults in primary care: relevant categories of their functioning from the research perspective, a scoping review. BMJ Open. 2021 Feb 17;11(2):e037333. doi: 10.1136/bmjopen-2020-037333.'}, {'pmid': '33234626', 'type': 'DERIVED', 'citation': 'Book S, Ulbrecht G, Tomandl J, Kuehlein T, Gotthardt S, Freiberger E, Graessel E. Laying the foundation for an International Classification of Functioning, Disability and Health Core Set for community-dwelling elderly adults in primary care: the clinical perspective identified in a cross-sectional study. BMJ Open. 2020 Nov 23;10(11):e038434. doi: 10.1136/bmjopen-2020-038434.'}, {'pmid': '30082366', 'type': 'DERIVED', 'citation': 'Tomandl J, Book S, Gotthardt S, Heinmueller S, Graessel E, Freiberger E, Kuehlein T, Hueber S, Hoyer S. Laying the foundation for a core set of the International Classification of Functioning, Disability and Health for community-dwelling adults aged 75 years and above in general practice: a study protocol. BMJ Open. 2018 Aug 5;8(8):e024274. doi: 10.1136/bmjopen-2018-024274.'}]}, 'descriptionModule': {'briefSummary': 'The sum of medical interventions can do more harm than good. Supporting patients\' resources instead of combating disease might effectively help reducing "too much medicine". A first step to approach this goal would be to have a classification tool that captures the essential features of a meaningful human life, namely body functions, activities, and participation. The International Classification of Functioning, Disability and Health (ICF) is the perfect framework to distinguish between necessary and unnecessary medical interventions by offering descriptions of outcomes of medical and non-medical interventions. However, though adequate and comprehensive in theory, it is impracticable in a primary care setting. Therefore, a core set of the ICF for the old and very old in primary care is needed. Four preparatory studies according to the international development guideline will be carried out: a systematic literature review to capture the research perspective, a qualitative study to assess the patients\' perspective, an experts\' survey and an empirical multicenter study to detect the clinical perspective.', 'detailedDescription': 'The systematic literature review captures the perspective of researchers on functioning of community dwelling people aged 75 years and older. Different literature databases will be searched combining search terms referring to community dwelling elderly and to functioning. Two investigators will independently screen the abstracts and titles for eligibility. In reviewing the full articles, the underlying concepts that are contained in the measures and in the article text will be identified, and then linked to the ICF categories using established linking rules. A frequency analysis will be conducted on the linked categories. The ICF categories that are identified in at least 5% of all publications will be included in the list of candidate categories.\n\nThe qualitative study aims to identify which aspects of functioning, environmental and personal factors are most important to community dwelling people aged 75 years and older. Participants will be provided with a camera for one week to take pictures of activities they are no longer able to perform or activities they still perform well. On the basis of these pictures, individual interviews and focus groups will be conducted. Meaningful concepts will be identified and linked to the ICF categories.\n\nThe expert survey aims to gather opinions of experts on aspects of functioning and environmental factors that are relevant for community dwelling people aged 75 years and older. Meaningful concepts will be identified and linked to the ICF categories.\n\nThe empirical multicenter study aims to identify the most common problems experienced by community-dwelling people aged 75 and older using clinical assessments. A health professional will conduct semi-structured interviews based on the extended ICF checklist. This is a selection of 125 categories that are considered to be most important for clinical practice. This list is extended by other categories thought to be sensitive to functioning in old age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community-dwelling people aged 75 years and older.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Systematic review:\n\nInclusion criteria:\n\n* conducted in the EU, EFTA countries, Australia, New Zealand, USA, Canada\n* published in a peer-review journal\n* published since 2007\n* RCT, controlled clinical trial, cross-sectional study, observational study, qualitative study\n\nExclusion criteria:\n\n* studies which are solely based on one certain disease\n* studies which are solely based on one ethnic group\n* studies with hospitalized participants\n\nQualitative study/empirical multicenter study:\n\nInclusion criteria:\n\n* community-dwelling people aged 75 years and older\n\nExclusion criteria:\n\n* people with dementia\n* people living in nursing homes\n* people in palliative care\n\nExpert survey:\n\nInclusion criteria\n\n* General practitioners, geriatricians and caregivers with at least two years of professional experience in ambulatory care.'}, 'identificationModule': {'nctId': 'NCT03384732', 'acronym': 'ICF', 'briefTitle': 'Development of an ICF Core Set for Geriatric Patients in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Development of a Core Set of the International Classification of Functioning, Disability and Health (ICF) for Geriatric Patients in Primary Care', 'orgStudyIdInfo': {'id': '01GY1605'}}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen, Institute of General Practice', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Thomas Kühlein, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitätsklinikum Erlangen, Institute of General Practice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}, {'name': 'University of Erlangen-Nürnberg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'johanna tomandl', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}