Trial Outcomes & Findings for CB3 Pilot (Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia) (NCT NCT05697380)

Last Updated: 2024-10-16

Results Overview

Communication Confidence Rating Scale in Aphasia, a 0-100 numeric rating scale with 0 representing 'not confident' and 100 representing 'very confident'. Higher scores indicate greater confidence. (Note Primary Outcome Measure was not collected for care-partners)

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time

Results posted on

2024-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Communication Bridge™ (PPA Participants) Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted.	Experimental: Communication Bridge™ (Care Partners) Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted.
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CB3 Pilot (Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time

Outcome measures

Outcome measures
Measure	Experimental: Communication Bridge™ (PPA Participants) n=4 Participants Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted.
Change in Communication Confidence (CCRSA) Post-Intervention Evaluation 4 (at 2 months)	65.91 score on a scale Standard Deviation 6.90
Change in Communication Confidence (CCRSA) Block 6 Evaluation (at 12 months)	61.36 score on a scale Standard Deviation 12.19
Change in Communication Confidence (CCRSA) Block 4 Evaluation (Baseline)	64.32 score on a scale Standard Deviation 8.60
Change in Communication Confidence (CCRSA) Block 5 Evaluation (at 6 months)	63.00 score on a scale Standard Deviation 8.31
Change in Communication Confidence (CCRSA) Post-Intervention Evaluation 5 (at 8 months)	64.77 score on a scale Standard Deviation 9.72

Adverse Events

Experimental: Communication Bridge™ (PPA Participants)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Experimental: Communication Bridge™ (Care Partners)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Communication Bridge™ (PPA Participants) n=4 participants at risk Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted.	Experimental: Communication Bridge™ (Care Partners) n=4 participants at risk Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted.
Surgical and medical procedures Medical Event	25.0% 1/4 • Number of events 2 • Adverse event data were collected over a period of 1 year from the participant's enrollment at baseline. Adverse Event Reporting below if for the PPA Participant Group ONLY.	0.00% 0/4 • Adverse event data were collected over a period of 1 year from the participant's enrollment at baseline. Adverse Event Reporting below if for the PPA Participant Group ONLY.

Other adverse events

Other adverse events
Measure	Experimental: Communication Bridge™ (PPA Participants) n=4 participants at risk Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted.	Experimental: Communication Bridge™ (Care Partners) n=4 participants at risk Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted.
Psychiatric disorders Other psychosocial events	0.00% 0/4 • Adverse event data were collected over a period of 1 year from the participant's enrollment at baseline. Adverse Event Reporting below if for the PPA Participant Group ONLY.	50.0% 2/4 • Number of events 2 • Adverse event data were collected over a period of 1 year from the participant's enrollment at baseline. Adverse Event Reporting below if for the PPA Participant Group ONLY.
Musculoskeletal and connective tissue disorders medical event (non serious)	25.0% 1/4 • Number of events 1 • Adverse event data were collected over a period of 1 year from the participant's enrollment at baseline. Adverse Event Reporting below if for the PPA Participant Group ONLY.	0.00% 0/4 • Adverse event data were collected over a period of 1 year from the participant's enrollment at baseline. Adverse Event Reporting below if for the PPA Participant Group ONLY.

Additional Information

Dr. Emily Rogalski

University of Chicago

Phone: 855-824-7887

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Experimental: Communication Bridge™ (PPA Participants) n=4 Participants Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted.	Experimental: Communication Bridge™ (Care-Partners) n=4 Participants Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted.	Total n=8 Participants Total of all reporting groups
Highest Degree Earned High School/GED	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Highest Degree Earned Some College	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Highest Degree Earned Did not complete high school	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Highest Degree Earned Bachelor's Degree	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Highest Degree Earned Master's Degree	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Highest Degree Earned Advanced Graduate/Phd	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants