NCT04543084

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 22, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2022

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

August 27, 2020

Last Update Submit

August 31, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Reading comprehension

    At first session and at last session time in between up to 5 months

Study Arms (1)

Single-Subject Design

OTHER

Each participant will go through a baseline phase and then an intervention phase.

Behavioral: Logbook

Interventions

LogbookBEHAVIORAL

Participants will record practice in a logbook.

Single-Subject Design

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15228, United States

Location

MeSH Terms

Conditions

AphasiaStroke

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Elena V. Donoso Brown, PhD

    Duquesne University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Single-subject Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 9, 2020

Study Start

January 22, 2021

Primary Completion

September 6, 2022

Study Completion

September 6, 2022

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations