Home Program Practice for People With Language Disorders After Stroke

Improving Home Program Practice for People With Language Disorders After Stroke

Logbooks are one of the most commonly used methods to both support and track adherence in research studies. This study will look at using logbooks to support adherence to reading practice for individuals with post-stroke aphasia. It is thought that using a logbook will increase practice time.

Study Overview

• Status: Completed
• Conditions: Stroke; Aphasia
• Intervention / Treatment: Behavioral: Logbook

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15228
      • Duquesne University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• at least 6 months post left hemisphere stroke with a diagnosis of aphasia
• must have self-reported interest in working to improve reading comprehension
• access to the Internet
• speak English as a primary language

Exclusion Criteria:

• significant visual or hearing impairment as determined by "aphasia-friendly" and age-appropriate screening
• actively receiving speech-language pathology services in which computerized or reading comprehension home practice activities are assigned/requested
• severe auditory comprehension impairment that limits understanding of one-step directions (i.e., Western Aphasia Battery-Revised sequential commands subtest score below 8).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single-Subject Design; Each participant will go through a baseline phase and then an intervention phase.	Behavioral: Logbook; Participants will record practice in a logbook.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in minutes of practice	The number of minutes practiced	Up to 11 weeks
Change in percentage of adherence to practice goal	The amount of practice compared to the goal	Up to 11 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading comprehension	As measured by performance on the Reading Comprehension Battery for Aphasia-2 (RCBA-2). A higher score is better.	At first session and at last session time in between up to 5 months

Collaborators and Investigators

• Sponsor: Duquesne University
• Investigators: Principal Investigator: Elena V. Donoso Brown, PhD, Duquesne University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Communication Disorders; Speech Disorders; Stroke; Aphasia; Language Disorders
• Other Study ID Numbers: 2019/12/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No