Clinical trial NCT03514186: The Intensive Comprehensive Aphasia Program (ICAP)
Official title: The Intensive Comprehensive Aphasia Program (ICAP): A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Keywords: Aphasia
Speech and Language Treatment
ICAP
Intensive Comprehensive Aphasia Program
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2018-05-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both treatment arms will provide 60 hours of comprehensive aphasia therapy. In the ICAP arm, the 60 hours of treatment will be applied intensively, 4 hours per day, 5 days a week for three weeks. In the Distributed Treatment arm, the 60 hours of comprehensive treatment will be distributed over 15 weeks (i.e. two 2-hour visits per week).
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a randomized clinical trial that assesses the efficacy and cost-effectiveness of an Intensive Comprehensive Aphasia Program (ICAP), specifically focusing on the variable of intensity. Half of the participants will receive 60 hours of intensive treatment over three weeks, while the other half will receive the same amount and type of comprehensive treatment distributed over 15 weeks.

Detailed description: Recent research has emphasized the need for intensive aphasia treatment in order to make the long-term neuroplastic changes associated with recovery and rehabilitation following a stroke. Furthermore, studies have indicated that intensive aphasia treatment is more efficacious than less intensive treatment. Rather than being influenced by such evidence, the reality is that public and private payers are drastically reducing services to persons with aphasia (PWA). Legislation has seriously curtailed the amount of treatment a PWA may receive after hospitalization. Often patients are eligible for only a limited number of treatment sessions over a limited period of time. In some cases, they may not receive any treatment for their communication disorder following their acute hospitalization. Reduced resources (e.g. transportation difficulties, therapist shortages in rural areas) also may severely limit available services.

The Intensive Comprehensive Aphasia Program (ICAP) may be a creative, cost-effective and sustainable option for delivering meaningful and necessary aphasia services. Despite the growing numbers of ICAPs, there is little evidence about their efficacy, effectiveness, or cost-effectiveness. All stakeholders need this evidence. Funding agencies require evidence to make decisions about their investments in aphasia rehabilitation. People with aphasia and their families should have evidence prior to investing their money and time into such programs, and speech and language pathologists have an ethical obligation to provide evidence-based practices.

Based on evidence regarding treatment intensity that has translated principles of neuroplasticity from animal models to stroke recovery, the investigators hypothesize that 60 hours of comprehensive treatment will result in significant improvements in (a) performance-based, (b) client-reported, and (c) surrogate-reported assessments of communication skills, community participation, and health-related quality of life. They also hypothesize that when 60 hours of comprehensive treatment is provided intensively over 3 weeks, the magnitude and rate of improvement as well as the extent to which improvements are maintained will be greater than when the 60 hours of comprehensive treatment is distributed over 15 weeks. Because the investigators hypothesize that the magnitude and rate of improvement will be greater with the intensive ICAP than with the distributed ICAP, they further hypothesize that the intensive ICAP will be more cost-effective than the distributed ICAP.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of an aphasia subsequent to a left-hemisphere infarct that is confirmed by CT scan or MRI
2. an Aphasia Quotient score on the Western Aphasia Battery of 20-85.
3. 6 months post injury
4. premorbidly fluent in English
5. receiving no concomitant speech-language therapy

Exclusion Criteria:

1. diagnosis of Global aphasia
2. any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's disease and other dementias, or traumatic brain injury
3. any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization (subjects with mood disorders who are currently stable on treatment will be considered)
4. active substance abuse.

Primary outcomes:
measure: Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
timeFrame: Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment)
Secondary outcomes:
measure: Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
timeFrame: Change from pre-treatment to 3 month follow-up
measure: Assessment for Living with Aphasia (ALA)
timeFrame: Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment)
measure: Assessment for Living with Aphasia (ALA)
timeFrame: Change from pre-treatment to 3 month follow-up
measure: The Communication Confidence Rating Scale for Aphasia (CCRSA)
timeFrame: Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment)
measure: The Communication Confidence Rating Scale for Aphasia (CCRSA)
timeFrame: Change from pre-treatment to 3 month follow-up
measure: The Communicative Effectiveness Index (CETI)
timeFrame: Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment)
measure: The Communicative Effectiveness Index (CETI)
timeFrame: Change from pre-treatment to 3 month follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Leora Cherney, PhD
role: PRINCIPAL_INVESTIGATOR
References: