Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT00158106
Status:
COMPLETED
Last Update Posted:
2005-09-12
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013060', 'term': 'Speech'}], 'ancestors': [{'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007808', 'term': 'Language Therapy'}], 'ancestors': [{'id': 'D012049', 'term': 'Rehabilitation of Speech and Language Disorders'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'ECT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2005-08'}, 'lastUpdateSubmitDate': '2005-09-07', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be functional communicative ability.'}], 'secondaryOutcomes': [{'measure': "The economic analysis to estimate incremental cost effectiveness and net benefit of the intervention. Qualitative study to examine service users' and carers' perspectives Speech and Language Therapy vs control treatment."}]}, 'conditionsModule': {'keywords': ['functional communicative ability', 'cost effectiveness', 'service user preferences'], 'conditions': ['Speech or Language Impairment Following Stroke']}, 'descriptionModule': {'briefSummary': 'This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.', 'detailedDescription': "Research Question: This is the pilot phase of a two-phase study. Phase 1 - What is the feasibility of conducting a randomised controlled trial of therapy for adults with post-stroke communication impairment? to be followed in 2006 by Phase 2 - What are the effectiveness, costs and service user preferences, for the provision of speech and language therapy for communication difficulties experienced by people in hospital with a stroke? Methodology: Phase 1 - Qualitative (focus groups \\& individual interviews) and quantitative (pilot RCT). Phase 2 - Qualitative (focus groups \\& individual interviews) and quantitative (a pragmatic, multicentred, randomised controlled trial, stratified by diagnosis and therapist/centre, using an 'intention to treat' approach). Discrete choice experiments will be used to determine cost effectiveness.\n\nOutcome Measures: The primary outcome will be functional communicative ability. The economic analysis will estimate the incremental cost effectiveness and net benefit of the intervention group compared to the control group from a societal perspective. The qualitative study will examine service users' and carers' perspectives on the process and effects of Speech and Language Therapy or the control treatment.\n\nSample Group: Adults with dysarthria or aphasia, seen early after admission to hospital with a stroke. Exclusions: subarachnoid haemorrhage, progressive dementia, expected recovery without therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with communication impairment following a new stroke\n\nExclusion Criteria:\n\n* Not fluent in the English language\n* Subarachnoid haemorrhage\n* Pre-existing, progressive dementia or learning disability\n* Palliative care only or deceased since admission\n* Resident outside the treatment area'}, 'identificationModule': {'nctId': 'NCT00158106', 'briefTitle': 'Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)', 'organization': {'class': 'OTHER', 'fullName': 'NHS Health Technology Assessment Programme'}, 'officialTitle': 'Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)', 'orgStudyIdInfo': {'id': 'HTA ref. 02/11/04'}, 'secondaryIdInfos': [{'id': 'ISRCTN78617680'}, {'id': '04/MRE03/30'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Speech and Language therapy for dysarthria and/or aphasia', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9PL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Audrey Bowen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Manchester, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Health Technology Assessment Programme', 'class': 'OTHER'}}}}