Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 11:15 PM
Study NCT ID:
NCT02825927
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2016-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swallowing Function, Oral Health, and Food Intake in Old Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-15', 'studyFirstSubmitDate': '2016-07-04', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Swallowing function', 'timeFrame': 'Baseline, 5 weeks and 6 months post-intervention', 'description': 'Change in swallowing function measured by the Swallowing Capacity Test (SCT) combined with a teaspoon test. Comparisons between intervention-and control group will be made.'}], 'secondaryOutcomes': [{'measure': 'Quality of life related to swallowing', 'timeFrame': 'Baseline, 5 weeks and 6 months post-intervention', 'description': 'Change in quality of life related to swallowing measured by the Swallowing Quality of Life Questionnaire (SWAL-QOL). Comparisons between intervention-and control group will be made.'}, {'measure': 'Oral Health', 'timeFrame': 'Baseline, 5 weeks and 6 months post-intervention', 'description': 'Change in oral health status measured by the Revised Oral Assessment Guide (ROAG). Comparisons between intervention-and control group will be made.'}, {'measure': 'Food Intake', 'timeFrame': 'Baseline, 5 weeks and 6 months post-intervention', 'description': 'Change in nutritional status measured by the Minimal Eating Observation and Nutrition Test Version II ( MEONF-II). Comparisons between intervention-and control group will be made.'}, {'measure': 'Activity of daily living', 'timeFrame': 'Baseline, 5 weeks and 6 months post-intervention', 'description': 'Change in status regarding activity of daily living measured by the Katz Index of Independence in Activities of Daily Living (Katz ADL-index). Comparisons between intervention-and control group will be made.'}, {'measure': 'Quality of life related to oral health', 'timeFrame': 'Baseline, 5 weeks and 6 months post-intervention', 'description': 'Change in quality of life related to oral health measured by the Oral Health Impact Profile (OHIP-14). Comparisons between intervention-and control group will be made.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dysphagia', 'Oral screen', 'Intervention', 'Oral Health', 'Food Intake', 'Quality of life', 'Elderly', 'Short-term care facilities'], 'conditions': ['Dysphagia', 'Deglutition Disorders', 'Swallowing Disorders', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '31062842', 'type': 'DERIVED', 'citation': 'Hagglund P, Hagg M, Wester P, Levring Jaghagen E. Effects of oral neuromuscular training on swallowing dysfunction among older people in intermediate care-a cluster randomised, controlled trial. Age Ageing. 2019 Jul 1;48(4):533-540. doi: 10.1093/ageing/afz042.'}, {'pmid': '29663160', 'type': 'DERIVED', 'citation': 'Hagglund P, Falt A, Hagg M, Wester P, Levring Jaghagen E. Swallowing dysfunction as risk factor for undernutrition in older people admitted to Swedish short-term care: a cross-sectional study. Aging Clin Exp Res. 2019 Jan;31(1):85-94. doi: 10.1007/s40520-018-0944-7. Epub 2018 Apr 16.'}, {'pmid': '28335729', 'type': 'DERIVED', 'citation': 'Hagglund P, Olai L, Stahlnacke K, Persenius M, Hagg M, Andersson M, Koistinen S, Carlsson E. Study protocol for the SOFIA project: Swallowing function, Oral health, and Food Intake in old Age: a descriptive study with a cluster randomized trial. BMC Geriatr. 2017 Mar 23;17(1):78. doi: 10.1186/s12877-017-0466-8.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether a specific rehabilitation program with oral screen used in an elderly population with dysphagia can improve elderly's swallowing capacity.", 'detailedDescription': "The present study aims to investigate the effects on swallowing function of a specific rehabilitation program with oral screen in the elderly population included. The present study is a part of an on-going cross-sectional, descriptive project called SOFIA where approximately 400 elderly individuals, admitted to short-term care (from the five regions/county Dalarna, Gävleborg, Örebro, Värmland and Västerbotten in Sweden), will be included. The purpose of the overall project is to gain a broader understanding of aspects of dysphagia, eating, oral health, and quality of life and care among elderly people in short-term care facilities.\n\nIn the present study, 35 elderly individuals identified with dysphagia in the overall project (swallowing capacity \\<10ml/sec) and without known dementia will be offered to participate and to undergo oral screen training for 5 weeks. The participants' status regarding swallowing, eating, quality of life and oral health will be assessed before and immediately after the intervention and 6-months post-intervention. A control group (35 people in short-term accommodation included in the overall project, identified with dysphagia but not offered the intervention) will undergo the same assessments (at start, after 5 weeks, and 6-month post-intervention) as the intervention group regarding swallowing, eating, quality of life and oral health status.\n\nCluster randomisation of short-term accommodation facilities will be made for those patients participating from the five regions/county to either intervention group or control group. Participants will be recruited consecutively to either the intervention- or the control group, depending on which short-term care facility they are staying at.\n\nThe investigators hypothesize that oral screen rehabilitation for elderly individuals with dysphagia and with different diagnoses treated in short-term care results in improved swallowing capacity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65\n* Admitted to short-term care facility ≥ 3 days\n* Included in the overall project SOFIA and with a swallowing capacity \\<10ml/sec\n\nExclusion Criteria:\n\n* Incapable of making decisions'}, 'identificationModule': {'nctId': 'NCT02825927', 'acronym': 'SOFIA', 'briefTitle': 'Swallowing Function, Oral Health, and Food Intake in Old Age', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Swallowing Function, Oral Health, and Food Intake in Old Age', 'orgStudyIdInfo': {'id': '2013/100/3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intensive training with oral screen for 5 weeks.', 'interventionNames': ['Other: Oral screen']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group is not offered any intervention.'}], 'interventions': [{'name': 'Oral screen', 'type': 'OTHER', 'description': 'The oral screen is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial muscles.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701 11', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Region Örebro län', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Eva Carlsson, PhD, Nurse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Örebro'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Örebro County', 'class': 'OTHER'}, {'name': 'Karlstad University', 'class': 'OTHER'}, {'name': 'Region Gävleborg', 'class': 'OTHER'}, {'name': 'Dalarna University', 'class': 'OTHER'}, {'name': 'Örebro University, Sweden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}