Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-04-23 @ 9:56 AM
Study NCT ID:
NCT03183960
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stroke - 65 Plus. Continued Active Life.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Activity (accelerometers)', 'timeFrame': 'Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital', 'description': 'Change of activity'}, {'measure': 'Caregiver Burden Scale', 'timeFrame': 'Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital', 'description': 'Change of caregivers burden'}], 'primaryOutcomes': [{'measure': 'Stroke Self-efficacy questionnaire', 'timeFrame': 'Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital', 'description': 'Change of Self-efficacy'}], 'secondaryOutcomes': [{'measure': 'Impact on participation and Autonomy Questionnaire', 'timeFrame': 'Measured 3 and 9 months post discharged from rehabilitation hospital', 'description': 'Change of Impact on participation and Autonomy'}, {'measure': 'Stroke Specific Quality of Life Scale Questionnaire(short version)', 'timeFrame': 'Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital', 'description': 'Change of Specific Quality of Life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-management', 'Quality of Life', 'Self-efficacy', 'Support', 'Stroke', 'Older adults'], 'conditions': ['Self-management', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '38587056', 'type': 'DERIVED', 'citation': 'Pallesen H, Pedersen SKS, Sorensen SL, Naess-Schmidt ET, Brunner I, Nielsen JF, Kjeldsen SS. "Stroke - 65 plus. Continued active life." A randomized controlled trial of a self-management neurorehabilitation intervention for elderly people after stroke. Disabil Rehabil. 2025 Jan;47(1):104-113. doi: 10.1080/09638288.2024.2338190. Epub 2024 Apr 8.'}, {'pmid': '34994306', 'type': 'DERIVED', 'citation': 'Pedersen SKS, Pallesen H. Stroke self-efficacy questionnaire - Denmark (SSEQ-DK): test-retest of the Danish version. Top Stroke Rehabil. 2023 Mar;30(2):193-202. doi: 10.1080/10749357.2021.2016097. Epub 2022 Jan 7.'}, {'pmid': '31113442', 'type': 'DERIVED', 'citation': 'Sorensen SL, Pedersen SKS, Pallesen H. Social psychological mechanisms and processes in a novel, health professional-led, self-management intervention for older stroke individuals: a synthesis and phenomenological study. BMC Health Serv Res. 2019 May 22;19(1):320. doi: 10.1186/s12913-019-4150-x.'}, {'pmid': '30454014', 'type': 'DERIVED', 'citation': 'Pallesen H, Naess-Schmidt ET, Kjeldsen SS, Pedersen SKS, Sorensen SL, Brunner I, Nielsen JF. "Stroke - 65 Plus. Continued Active Life": a study protocol for a randomized controlled cross-sectoral trial of the effect of a novel self-management intervention to support elderly people after stroke. Trials. 2018 Nov 19;19(1):639. doi: 10.1186/s13063-018-2961-4.'}]}, 'descriptionModule': {'briefSummary': "Since august 2016, the researchers at a highly specialized neurorehabilitation hospital in a Danish region with 1.2 inhabitants have in cooperation with health professionals from a specialized neurorehabilitation in a Danish municipality with 336,000 inhabitants, worked through and is still working with an iterative process in the development of a novel self-management support intervention for elderly stroke individuals.The intervention is going to be implemented into the second phase- a randomized clinical controlled trial (RCT) in the project named 'Stroke - 65 plus. Continued active life'.", 'detailedDescription': "Background: Elderly adults represent the majority of stroke cases worldwide. Sequelae after a stroke causes the stroke individuals to live a more isolated life 5 years after the stroke. This makes the stroke individuals an especially vulnerable group of elderly people regarding social reintegration. Reintegration into the community post-stroke depends highly on support from the family. However, the stroke individual's closest relatives are at risk of developing anxiety and depression.\n\nThe aim of this study is to investigate the effect of a novel self-management intervention supporting older adults after stroke\n\nMethods/Design: Randomized controlled observer-blind trial. More than sixty stroke survivors over 65 years will two weeks before leaving a rehabilitation hospital be randomized to either a group receiving conventional rehabilitation (control) or a novel self-management intervention addition to standard rehabilitation.\n\nDuring a period of 6 months the patients will be offered additional 6-8 sessions of self-management intervention of 45-60 minutes duration by a physiotherapist or an occupational therapist.\n\nStudy outcome measurements: Stroke Self-efficacy questionnaire, Stroke Specific Quality of Life Scale and Impact on participation and Autonomy and activity by accelerometers will be evaluated at baseline, three and nine months post hospital treatment.\n\nPatient, informal caregiver and therapist satisfaction will be with examined with questionnaires and interviews.\n\nDiscussion: Self-management interventions are promising tools for rehabilitation of self-efficacy, quality of life as well as participation and autonomy. The introduction of novel self management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke, quality of life and burden on relatives. Stroke 65+ trial will provide further evidence of self management strategies to clinicians, patients and health economists."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stroke survivors with rehabilitation needs discharge from rehabilitation hospital to home\n\nExclusion Criteria:\n\n* do not understand danish Montreal Cognitive assessment (MOCA) below 20'}, 'identificationModule': {'nctId': 'NCT03183960', 'acronym': 'Stroke65+', 'briefTitle': 'Stroke - 65 Plus. Continued Active Life.', 'organization': {'class': 'OTHER', 'fullName': 'Central Jutland Regional Hospital'}, 'officialTitle': 'Stroke - 65 Plus. Continued Active Life. A Randomised Controlled Trial of the Effect of a Novel Self-management Intervention Supporting Older Adults After Stroke', 'orgStudyIdInfo': {'id': 'JutlandRH54962'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mentor', 'description': 'An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors. A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital', 'interventionNames': ['Behavioral: Mentor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional rehabilitation', 'description': 'An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors. A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital', 'interventionNames': ['Behavioral: Mentor']}], 'interventions': [{'name': 'Mentor', 'type': 'BEHAVIORAL', 'otherNames': ['Self-mangement'], 'description': 'Traditional rehabilitation.', 'armGroupLabels': ['Mentor', 'Traditional rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8450', 'city': 'Hammel', 'state': 'Jutland', 'country': 'Denmark', 'facility': 'Region Hospital Hammel Neurocentre', 'geoPoint': {'lat': 56.25762, 'lon': 9.86316}}, {'zip': '8450', 'city': 'Hammel', 'country': 'Denmark', 'facility': 'Region Hospital Hammmel Neurorehabilitation', 'geoPoint': {'lat': 56.25762, 'lon': 9.86316}}], 'overallOfficials': [{'name': 'Hanne Pallesen, Post Doc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hammel Neurorehabilitation Centre and University Research Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Jutland Regional Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist, PhD. Head of Clinical Physiotherapy Research, at Hammel Neurorehabilitation Centre and University Research Clinic, Hammel, Denmark', 'investigatorFullName': 'Hanne Pallesen', 'investigatorAffiliation': 'Central Jutland Regional Hospital'}}}}