Living With Aphasia: An International Study

NCT01234090 | Terminated DMC

• 1 other identifier: 10-01628
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective cohort study hypothesizes that an analysis of parallel qualitative and quantitative data is necessary to examine the full experience of living with aphasia. It is also hypothesized that there are specific factors that act as barriers or facilitators to successfully living with aphasia. A unique aspect of the project is the use of the Assessment for Living with Aphasia (ALA), a new aphasia friendly measure based on the World Health Organization International Classification of Functioning, Disability and Health (WHO ICF). Each session will assess written and spoken language, functional communication, mobility, Activities of Daily Living (ADL) function, burden of stroke, quality of life, and depression.

Conditions

Aphasia

Keywords

Aphasia; Quality of Life

Outcome Measures

Primary Outcomes (1)

• The Assessment for Living with Aphasia

  A new, aphasia friendly measure based on the World Health Organization International Classification of Functioning, Disability, and Health. It is a specialized tool using a self-rating scale and is focused on specific themes that have emerged from previous research.

  9 months

Secondary Outcomes (7)

• Western Aphasia Battery - Revised

  9 months

• Successfully Living with Aphasia Rating Scale

  9 months

• Burden of Stroke Scale

  9 months

• Aphasia Depression Rating Scale

  9 months

• The Wepman Self-Correction Scale

  9 months

Study Arms (1)

Persons with Aphasia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inpatient/outpatient hospital population

You may qualify if:

• years of age and older, willingness to be videotaped, first incidence of aphasia secondary to stroke with stroke onset ≤2.5
• months pre-stroke or 3.5 months post-stroke with no significant complicating concomitant conditions (e.g. dementia, schizophrenia),
• premorbid fluency/literacy in English, and no history of psychiatric disorder, and sufficient communication ability (including adequate hearing and vision) in English to participate in an interview as determined by a qualified speech pathologist based on administration of the Western Aphasia Battery - Revised and clinical observation.
• participants will be enrolled in the study at 3 months post onset (+/- 2 weeks) wherever they are living, and presence of aphasia will be confirmed at the beginning of the first interview using the Aphasia Quotient cut offs of the Western Aphasia Battery.
• participants with severe global aphasia will only be excluded after the interview if meaningful responses cannot be obtained using all available communication support tools. Hence, participants with a range of aphasia severity will be included.

You may not qualify if:

• unwillingness to be videotaped
• onset of stroke \<2.5 months post and \>3.5 months post
• moderate or severe dementia
• symptoms of another preexisting neurological condition other than or in addition to aphasia due to stroke, or drug abuse
• neurological surgical treatment not including a surgical treatment specifically for treatment of stroke, absence of aphasia.
• no subjects will have a hearing loss unexpected for his/her chronological age.

Sponsors & Collaborators

• NYU Langone Health: lead
• The Solomon Foundation: collaborator
• The University of Queensland: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martha T Sarno, MA,Dhonorary

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: November 4, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

US (1)