Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
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Purpose
This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.
| Condition | Intervention |
|---|---|
|
Speech or Language Impairment Following Stroke |
Procedure: Speech and Language therapy for dysarthria and/or aphasia |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
| Official Title: | Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study) |
- The primary outcome will be functional communicative ability.
- 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.
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | August 2005 |
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults with communication impairment following a new stroke
Exclusion Criteria:
- Not fluent in the English language
- Subarachnoid haemorrhage
- Pre-existing, progressive dementia or learning disability
- Palliative care only or deceased since admission
- Resident outside the treatment area
Contacts and Locations| United Kingdom | |
| Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester | |
| Manchester, United Kingdom, M13 9PL | |
| Principal Investigator: | Audrey Bowen, PhD | The University of Manchester, UK |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00158106 History of Changes |
| Other Study ID Numbers: | HTA ref. 02/11/04, ISRCTN78617680, 04/MRE03/30 |
| Study First Received: | September 7, 2005 |
| Last Updated: | September 7, 2005 |
| Health Authority: | United Kingdom: Department of Health |
Keywords provided by NHS Health Technology Assessment Programme:
|
functional communicative ability cost effectiveness service user preferences |
Additional relevant MeSH terms:
|
Language Disorders Stroke Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013