Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158106
Status:
COMPLETED
Last Update Posted:
2005-09-12
First Post:
2005-09-07
Brief Title:
Assessing the Effectiveness of Communication Therapy in the North West The ACT NoW Pilot Study
Sponsor:
NHS Health Technology Assessment Programme
Organization:
NHS Health Technology Assessment Programme
Study Overview
Official Title:
Assessing the Effectiveness of Communication Therapy in the North West The ACT NoW Pilot Study
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke
Detailed Description:
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 therapistcentre using an intention to treat approach Discrete choice experiments will be used to determine cost effectiveness
Outcome 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
Sample Group Adults with dysarthria or aphasia seen early after admission to hospital with a stroke Exclusions subarachnoid haemorrhage progressive dementia expected recovery without therapy
Outcome 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
Sample Group Adults with dysarthria or aphasia seen early after admission to hospital with a stroke Exclusions subarachnoid haemorrhage progressive dementia expected recovery without therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04MRE0330 | None | None | None |
| ISRCTN78617680 | None | None | None |