Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-04-19 @ 12:29 AM
Study NCT ID:
NCT03270592
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2017-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Service and Hearing Dogs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-01', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total costs', 'timeFrame': 'Three months follow-up', 'description': 'Health care costs, cost of informal care, municipal costs'}, {'measure': 'Health related quality of life, EQ-5D', 'timeFrame': 'Tree months follow-up', 'description': 'EQ-5D is a generic quality of life instrument including five dimensions'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness', 'timeFrame': 'Life time perspective', 'description': 'Cost per quality adjusted life years (QALY)'}, {'measure': 'Health related quality of life, RAND-36', 'timeFrame': 'Three months follow-up', 'description': 'RAND-36 is a generic quality of life instrument including eight dimensions'}, {'measure': 'WHO-5 wellbeing index', 'timeFrame': 'Three months follow-up', 'description': 'WHO-5 wellbeing index is an index measuring wellbeing on five dimensions'}, {'measure': 'Rosenberg self-esteem scale', 'timeFrame': 'Three month follow-up', 'description': 'Rosenberg self-esteem scale measures self esteem with ten questions'}, {'measure': 'EQ-VAS', 'timeFrame': 'Three months follow-up', 'description': 'EQ-VAS is a Visual analogue scale ranging from 0 to 100 (perfect Health)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Service dogs', 'Alert dogs', 'Costs', 'Quality of Life', 'Cost-effectiveness'], 'conditions': ['Impairment', 'Diabetes', 'Epilepsy']}, 'referencesModule': {'references': [{'pmid': '29945630', 'type': 'DERIVED', 'citation': 'Lundqvist M, Levin LA, Roback K, Alwin J. The impact of service and hearing dogs on health-related quality of life and activity level: a Swedish longitudinal intervention study. BMC Health Serv Res. 2018 Jun 27;18(1):497. doi: 10.1186/s12913-018-3014-0.'}]}, 'descriptionModule': {'briefSummary': 'For persons with impairments and certain illnesses the use of service dogs may have positive effect. The effects of using these dogs to assist in every day life need to be studied further.The aim of the study was to assess how health care consumption was effected by using certified service dogs and to study the cost-effectiveness of having a certified service dog.', 'detailedDescription': 'This is an exploratory before and after study with the aim to study how health care consumption was effected by using certified service dogs and to study the cost-effectiveness of having a certified service dog. Data was collected before the education of the dog started and the follow-up was made three months after completion of the education. Data was collected on Health care consumption and outcomes in terms Health related quality of life and Health outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 16 years\n* Having a regular companion dog\n* Being in need of a certified service dog (due to impairment, diabetes, epilepsy and deafness)\n\nExclusion Criteria:\n\n* Psychiatric illness'}, 'identificationModule': {'nctId': 'NCT03270592', 'briefTitle': 'Assessment of Service and Hearing Dogs', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Assessment of Service and Hearing Dogs', 'orgStudyIdInfo': {'id': 'Dnr 157-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Service dogs', 'description': 'Single arm study using a before after design where Before represent having a regular companion dog and after represent having a certified service dog', 'interventionNames': ['Other: Service dog']}], 'interventions': [{'name': 'Service dog', 'type': 'OTHER', 'description': 'Use of a individualized certified service dog', 'armGroupLabels': ['Service dogs']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lars-Åke Levin, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Linkoeping University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Health and Social Affairs, Sweden', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Martina Lundqvist', 'investigatorAffiliation': 'Linkoeping University'}}}}