Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT05897905
Status:
UNKNOWN
Last Update Posted:
2023-09-29
First Post:
2023-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Follow up Care for People After Minor Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D005221', 'term': 'Fatigue'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Qualitative interviews', 'timeFrame': '13 weeks', 'description': 'Semi-structured'}], 'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'Baseline', 'description': 'Proportion of participants randomised relative to the total number meeting the inclusion criteria.'}, {'measure': 'Treatment completion rate', 'timeFrame': '6 weeks post randomisation', 'description': 'Proportion of participants who attend both follow-up appointments'}, {'measure': 'Retention rate', 'timeFrame': '12 weeks post randomisation', 'description': 'Proportion of participants that complete the follow-up questionnaires'}], 'secondaryOutcomes': [{'measure': 'PROMIS10', 'timeFrame': '2 weeks and 12 weeks', 'description': 'Patient reported outcome measures information system'}, {'measure': 'Health Care Climate Questionnaire Short Form', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Patient reported outcome measure'}, {'measure': 'MOCA', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Cognitive assessment'}, {'measure': 'PHQ9', 'timeFrame': '12 weeks', 'description': 'Mood score'}, {'measure': 'GAD7', 'timeFrame': '12 weeks', 'description': 'Anxiety score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Secondary prevention', 'Adjustment to life after stroke', 'Hidden impairments', 'Cognition', 'Mood', 'Fatigue'], 'conditions': ['Stroke, Acute']}, 'descriptionModule': {'briefSummary': 'The goal of this feasibility study is to ascertain if this follow-up programme of care can feasibly be implemented within a healthcare system with people after minor stroke.\n\nThe main feasibility questions are:\n\ni) To establish recruitment uptake ii) To establish treatment adherence iii) To determine participant retention. Participants will be randomly allocated to the intervention and control group. Those in the intervention group will receive a follow-up telephone call at two weeks after discharge and a second follow-up appointment at six weeks after discharge. Outcome measures will be taken at twelve weeks after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult ≥18\n* Clinical or radiological diagnosis of minor stroke from a stroke consultant.\n* Admitted to HASU or seen in rapid assessment/TIA clinic.\n* Pre-admission mRS of 0-3 with no formal package of care prior to stroke.\n* Discharge mRS of 0-3.\n* No onward referral to community therapy team or for package of care.\n* Has capacity to consent.\n\nExclusion Criteria:\n\n* Any serious co-morbidities that would impact a person's ability to participate in the follow-up appointments and outcome measurement.\n* Insufficient English to engage in intervention and outcome measures and no family or friends to support with this.\n* Not resident in England.\n* Pregnant women."}, 'identificationModule': {'nctId': 'NCT05897905', 'briefTitle': 'Improving Follow up Care for People After Minor Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College Healthcare NHS Trust'}, 'officialTitle': 'A Feasibility Study Investigating an Early, Personalised, Follow-up Programme for People After Minor Stroke', 'orgStudyIdInfo': {'id': '23CX8211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'All participants will receive a brief routine stroke medical follow-up appointment.'}, {'type': 'EXPERIMENTAL', 'label': 'Personalised, holistic based follow-up appointments underpinned by self determination theory.', 'description': 'Participants will receive two follow-up appointments at two and six weeks after discharge.', 'interventionNames': ['Behavioral: Personalised, holistic follow-up appointments underpinned by self determination theory']}], 'interventions': [{'name': 'Personalised, holistic follow-up appointments underpinned by self determination theory', 'type': 'BEHAVIORAL', 'description': 'Appointment 1 (two weeks after discharge):\n\n* Address participants knowledge gaps as regards their stroke, medication and secondary prevention.\n* Detailed biopsychosocial review.\n* Understand participant priorities and jointly set goals.\n* Agreeing onward referrals if needed.\n* Written summary sent to GP with copy to participant.\n\nAppointment 2 (six weeks):\n\n* Review priorities identified in post stroke review checklist.\n* Review goals and plans from first appointment.\n* Address any new or persistent information gaps.\n* Review hidden impairments that may be impacting on return to work, activities of daily living, relationships or general well-being.\n* Agreeing onward referrals and action plan.\n* Written summary and plan sent to GP.', 'armGroupLabels': ['Personalised, holistic based follow-up appointments underpinned by self determination theory.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Imperial CHN Trust', 'role': 'CONTACT'}], 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Jennifer Crow', 'role': 'CONTACT', 'email': 'jcrow@ic.ac.uk', 'phone': '07795826663'}, {'name': 'Paresh Malhotra', 'role': 'CONTACT', 'email': 'p.malhotra@imperial.ac.uk', 'phone': '02033135525'}], 'overallOfficials': [{'name': 'Jennifer Crow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}