NCT02439853

Brief Summary

This is a study on Internet-based video-practice speech and language therapy for persons with primary progressive aphasia (PPA), behavioral-variant frontotemporal dementia (bvFTD), or related conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

March 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6.8 years

First QC Date

April 23, 2015

Last Update Submit

September 4, 2024

Conditions

Keywords

primary progressive aphasiaprogressive nonfluent aphasiaprogressive aphasiafrontotemporal dementiafrontotemporal lobar degeneration

Outcome Measures

Primary Outcomes (1)

  • Assessment of Functional Communication Abilities

    Functional Communication Abilities will be assessed through questionnaires about the participant's language and communication, neuropsychological testing, and speech and language therapy evaluations.

    Change from baseline assessment at 2-months, 6-months and 12-months post-treatment

Study Arms (2)

Check-In group

EXPERIMENTAL

Subjects in the Check-In group will undergo three check-in sessions with the speech therapist. These sessions will happen remotely, via video-chat, and will last less than an hour. They will occur at 3-, 4-, and 5-months from the subject's enrollment date.

Behavioral: Monthly Check-in Session

Control Arm

NO INTERVENTION

Subjects in the Control arm will not undergo three check-in sessions with the speech therapist.

Interventions

Subjects in the Check-In group will have an online session with a speech-language pathologist 3-, 4-, and 5-months from the subject's enrollment date.

Check-In group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of dementia with language as a primary symptom (i.e. aphasia)
  • An informant who knows the participant well and can answer questions the participant's communication ability
  • Adequate hearing to follow conversation (correction permitted)
  • Adequate vision (correction permitted)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Aphasia, Primary ProgressiveFrontotemporal DementiaPrimary Progressive Nonfluent AphasiaAphasiaFrontotemporal Lobar Degeneration

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Emily J Rogalski, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 12, 2015

Study Start

March 1, 2013

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations