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Stepped Care for Aphasia

Primary Purpose

Aphasia, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial intervention
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

18 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-81 years old Native English speaker (English fluency by age 7) Aphasia as a result of a left-hemisphere ischemic or hemorrhagic stroke (WAB-R Aphasia Quotient < 93.8) At least 1-month post-stroke Confirmation of left hemisphere stroke per medical records Discharged from hospital Participant is willing and able to consent for themselves. Exclusion Criteria: Uncorrected hearing or visual impairment that prevents completion of experimental activities as determined by self-report History of other neurological disorder or disease beside stroke (e.g., dementia, traumatic brain injury) as determined by self-report and/or medical records Self-reported history of premorbid learning disability Severe auditory comprehension deficits (as indicated by a score of more than two standard deviations below norms on the Auditory Verbal section of WAB-R)

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychosocial intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in the Hospital Anxiety and Depression Scale at 1-Month Follow-Up
Change in the total depression and anxiety Hospital Anxiety and Depression Scale scores between baseline and at 1-month post-treatment. Minimum score 0, maximum score 21 for each scale. Higher scores mean a worse outcome.

Secondary Outcome Measures

Change in Dynamic Visual Analogue Mood Scales at 1-Month Follow-Up
Total summary score (min: 0, max: 100, higher scores indicate better outcome) and sadness score (min: 0, max: 100, higher scores indicate better outcome)
Change in Stroke Aphasia Depression Questionnaire - 10 at 1-Month Follow-Up
Total score (min: 0, max: 30, higher scores indicate worse outcome)
Change in Behavioural Outcomes of Anxiety Scale at 1-Month Follow-Up
Total score (min: 0, max: 30, higher scores indicate worse outcome)
Change in Modified Perceived Stress Scale at 1-Month Follow-Up
Total score (min: 0, max: 40, higher scores indicate worse outcome)
Change in Stroke Aphasia Quality of Life - 39 at 1-Month Follow-Up
Total score (min: 1, max: 5), physical score (min: 1, max: 5), psychosocial score (min: 1, max: 5), and communication score (min: 1, max: 5), higher scores on all scales indicate better outcomes
Change in Communication Confidence Rating Scale for Aphasia at 1-Month Follow-Up
Total score (min: 10, max: 40, higher scores indicate better outcome)

Full Information

First Posted
April 7, 2023
Last Updated
May 1, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05851573
Brief Title
Stepped Care for Aphasia
Official Title
Stepped Care Model of Psychological Care for Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is recruiting people who had a stroke at least 1 month ago and now have a language impairment called aphasia. Living with aphasia can have devastating effects on communication and quality of life, and it is not uncommon for survivors with aphasia to face psychological problems like depression and anxiety. Participants who are eligible for this study will undergo baseline testing, engage in a 5-week treatment focused on psychological well-being, undergo post-treatment testing, and then testing again 1-month later. Check-in phone calls will be conducted during the 1-month off period and participants will be interviewed about their experience at the end of the study as well. Compensation will be provided to participants with aphasia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychosocial intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial intervention
Intervention Description
an SLP-administered 5-week treatment focused on psychological well-being
Primary Outcome Measure Information:
Title
Change in the Hospital Anxiety and Depression Scale at 1-Month Follow-Up
Description
Change in the total depression and anxiety Hospital Anxiety and Depression Scale scores between baseline and at 1-month post-treatment. Minimum score 0, maximum score 21 for each scale. Higher scores mean a worse outcome.
Time Frame
through study completion, an average of 10 weeks
Secondary Outcome Measure Information:
Title
Change in Dynamic Visual Analogue Mood Scales at 1-Month Follow-Up
Description
Total summary score (min: 0, max: 100, higher scores indicate better outcome) and sadness score (min: 0, max: 100, higher scores indicate better outcome)
Time Frame
through study completion, an average of 10 weeks
Title
Change in Stroke Aphasia Depression Questionnaire - 10 at 1-Month Follow-Up
Description
Total score (min: 0, max: 30, higher scores indicate worse outcome)
Time Frame
through study completion, an average of 10 weeks
Title
Change in Behavioural Outcomes of Anxiety Scale at 1-Month Follow-Up
Description
Total score (min: 0, max: 30, higher scores indicate worse outcome)
Time Frame
through study completion, an average of 10 weeks
Title
Change in Modified Perceived Stress Scale at 1-Month Follow-Up
Description
Total score (min: 0, max: 40, higher scores indicate worse outcome)
Time Frame
through study completion, an average of 10 weeks
Title
Change in Stroke Aphasia Quality of Life - 39 at 1-Month Follow-Up
Description
Total score (min: 1, max: 5), physical score (min: 1, max: 5), psychosocial score (min: 1, max: 5), and communication score (min: 1, max: 5), higher scores on all scales indicate better outcomes
Time Frame
through study completion, an average of 10 weeks
Title
Change in Communication Confidence Rating Scale for Aphasia at 1-Month Follow-Up
Description
Total score (min: 10, max: 40, higher scores indicate better outcome)
Time Frame
through study completion, an average of 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-81 years old Native English speaker (English fluency by age 7) Aphasia as a result of a left-hemisphere ischemic or hemorrhagic stroke (WAB-R Aphasia Quotient < 93.8) At least 1-month post-stroke Confirmation of left hemisphere stroke per medical records Discharged from hospital Participant is willing and able to consent for themselves. Exclusion Criteria: Uncorrected hearing or visual impairment that prevents completion of experimental activities as determined by self-report History of other neurological disorder or disease beside stroke (e.g., dementia, traumatic brain injury) as determined by self-report and/or medical records Self-reported history of premorbid learning disability Severe auditory comprehension deficits (as indicated by a score of more than two standard deviations below norms on the Auditory Verbal section of WAB-R)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Principal Investigator
Phone
513-325-6737
Email
blackett@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
513-325-6737
Email
blackett@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Stepped Care for Aphasia

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