Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-01 @ 9:56 PM
Study NCT ID:
NCT02648750
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2015-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stroke Self-Management Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2015-12-24', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Stroke Self-Efficacy Scale at 6 weeks', 'timeFrame': 'Baseline and 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline Modified Rivermead Mobility Index at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Functional mobility'}, {'measure': 'Change from baseline SIPSO at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'social integration'}, {'measure': 'Change from baseline EQ5D at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'health-related quality of life'}, {'measure': 'Change from baseline PHQ-9 at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'depression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['self-management', 'rehabilitation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This feasibility study evaluates whether it is possible to run a larger scale study to investigate the use of a self-management programme with adults who have recently had a stroke. Half of the participants will receive support with self-management from stroke therapists, while the other half will receive it from rehabilitation assistants.', 'detailedDescription': 'Supporting self-management post-stroke is a key priority in healthcare policy, but not yet embedded into the provision of stroke rehabilitation. Barriers to implementation include time and resource. The feasibility of using the Bridges Stroke Self-Management Programme within an Early Supported Discharge Service and delivery by Rehabilitation Assistants is unknown.\n\nThe aim of this study was to evaluate key trial parameters to inform the protocol of a future definitive trial into the effectiveness of Bridges delivered by rehabilitation assistants within an Early Supported Discharge Service.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of new stroke\n* Being referred to the ESD service\n* Medically stable\n* Able to give informed consent\n* Can follow a two-stage command\n\nExclusion Criteria:\n\n* Being discharged to a care home'}, 'identificationModule': {'nctId': 'NCT02648750', 'briefTitle': 'Stroke Self-Management Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service', 'organization': {'class': 'OTHER', 'fullName': 'University of Plymouth'}, 'officialTitle': 'A Stroke Self-Management Programme Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service: A Feasibility Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '177976'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation Assistant', 'description': 'Bridges stroke self-management programme. Delivered by rehabilitation assistants. Participants will receive a minimum of 4 sessions over a 4-6 week period.', 'interventionNames': ['Behavioral: Bridges self-management programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Therapist', 'description': 'Bridges stroke self-management programme. Delivered by registered stroke therapists (Occupational therapists or physiotherapists).\n\nParticipants will receive a minimum of 4 sessions over a 4-6 week period.', 'interventionNames': ['Behavioral: Bridges self-management programme']}], 'interventions': [{'name': 'Bridges self-management programme', 'type': 'BEHAVIORAL', 'description': "The Bridges self-management programme is based on self-efficacy principles. It includes a Bridges stroke workbook consisting of stroke survivors' experiences and strategies, with space to record and reflect on personal goals and achievements, which the practitioner will work through with the participant. The practitioner will also used strategies based on key principles of self-management during interactions with patients.", 'armGroupLabels': ['Rehabilitation Assistant', 'Therapist']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jenny Freeman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Plymouth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jenny Freeman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Reader in Physiotherapy and Rehabilitation', 'investigatorFullName': 'Jenny Freeman', 'investigatorAffiliation': 'University of Plymouth'}}}}