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Communication Bridge 2

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03371706
Acronym
CB2
Enrollment
190
Registered
2017-12-13
Start date
2018-04-03
Completion date
2023-03-23
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Progressive Aphasia

Keywords

aphasia, primary progressive aphasia, dementia, communication, frontotemporal dementia, Alzheimer's disease

Brief summary

This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild Primary Progressive Aphasia (PPA). The aim of the study is to help us better understand the effects of speech language therapy on communication abilities in individuals with PPA. Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for 12 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive 5 evaluations and 15 speech therapy sessions with a licensed speech therapist, as well as access to Communication Bridge, a personalized web application to practice home exercises that reinforce treatment strategies. There are no costs to participate in this study.

Interventions

Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.

Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

NIH Stage 2 behavioral clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

(person with PPA): 1. Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records) 2. English as primary language used in daily communication activities (by self-report) 3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report) 4. Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report) 5. Able to pass technology screening and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training) 6. Geriatric Depression Scale score ≤ 9 7. Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery. Inclusion Criteria (Co-enrolled communication partner): 1. 18+ years of age 2. English as primary language used in daily communication activities (by self-report) 3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report) 4. Able to pass technology screening\* and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)

Exclusion criteria

* A dementia diagnosis other than Primary Progressive Aphasia * Participation is co-enrolled in an outside speech language therapy program during the study course. * Communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia) Medical records will be requested and reviewed to determine eligibility.

Design outcomes

Primary

MeasureTime frameDescription
Change in Communication Confidence (CCRSA)5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 monthsCommunication 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.
Change in Communication Participation Item Bank (CPIB)5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 monthsCommunication Participation Item Bank is a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'. Higher scores indicate greater severity of communication challenges. We are reporting on change in CPIB scores using T-scores. The Communicative Participation Item Bank (CPIB) T-score range is as follows: T57.5 and above: Represents a normal experience of communicative participation or minimal problems T57.5-T45: Represents mild challenges T45-T35: Represents moderate challenges T35 and below: Represents severe challenges The CPIB is a patient-reported instrument that measures communicative participation. The mean T-score is 50, and the standard deviation is 10. Higher scores are more favorable, indicating less interference in participation. The ideal score, or someone who reports no problems with communicative participation, would be a T-score of 74.3
Change in Communication Participation Person Centered Goals4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 monthsThis measure assesses progress toward communication participation goals using Goal Attainment Scaling (GAS). Participants developed personalized goals, each set to a baseline value of '0'. Progress was tracked using a 7-point scale, where -3 represents 'no longer participating' and +3 represents 'exceeded goal'. Higher scores indicate better progress toward goal achievement. Goals were evaluated at 3, 6, 9, and 12 months, with the results reported as the percentage of goals that: Worsened (scores of -1, -2, or -3) No change (score remained at 0) Improved (scores of +1, +2, or +3), including getting close to, reaching, or exceeding the goal. The table below presents the percentage of goals falling into each of these categories at each assessment point.

Other

MeasureTime frameDescription
Change in Word Accuracy (Trained Words)5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 monthsproportion of participants accuracy on trained words. Higher values indicate greater number of words produced after first prompt. Range 0 - 30
Change in Script Accuracy (Trained Scripts)5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 monthsproportion of participants accuracy on trained scripts. Higher values indicate greater level of script performance as a proportion. Range 0 - 1.

Countries

United States

Participant flow

Participants by arm

ArmCount
Communication Bridge™ (Persons With Primary Progressive Aphasia)
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 in the two arms of the study.
56
Evidence-Based Impairment Focused (Persons With Primary Progressive Aphasia)
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants. Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
39
Total95

Baseline characteristics

CharacteristicCommunication Bridge™ (Persons With Primary Progressive Aphasia)TotalEvidence-Based Impairment Focused (Persons With Primary Progressive Aphasia)
Age, Customized
Age at baseline
66.9 years
STANDARD_DEVIATION 7.2
67.1 years
STANDARD_DEVIATION 7.4
67.4 years
STANDARD_DEVIATION 7.8
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
56 Participants94 Participants38 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
56 Participants93 Participants37 Participants
Sex: Female, Male
Female
25 Participants49 Participants24 Participants
Sex: Female, Male
Male
31 Participants46 Participants15 Participants
Years of education16.2 years
STANDARD_DEVIATION 2.5
16.4 years
STANDARD_DEVIATION 2.4
16.7 years
STANDARD_DEVIATION 2.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 560 / 39
other
Total, other adverse events
5 / 567 / 39
serious
Total, serious adverse events
7 / 564 / 39

Outcome results

Primary

Change in Communication Confidence (CCRSA)

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.

Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

Population: the number analyzed in some rows differs from the overall number analyzed due to participant withdrawal and missing data.

ArmMeasureGroupValue (MEAN)Dispersion
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Confidence (CCRSA)Post Intervention 1 (3 months)73.7 units on a scaleStandard Error 1.9
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Confidence (CCRSA)Post Intervention 2 (9 months)72.2 units on a scaleStandard Error 2.2
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Confidence (CCRSA)Six Months72.1 units on a scaleStandard Error 2.1
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Confidence (CCRSA)12 Months69.1 units on a scaleStandard Error 2.7
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Confidence (CCRSA)Baseline72.6 units on a scaleStandard Error 1.8
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Confidence (CCRSA)12 Months70.1 units on a scaleStandard Error 2.5
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Confidence (CCRSA)Baseline72.9 units on a scaleStandard Error 2.6
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Confidence (CCRSA)Post Intervention 1 (3 months)74.5 units on a scaleStandard Error 2.4
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Confidence (CCRSA)Six Months73.1 units on a scaleStandard Error 2.5
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Confidence (CCRSA)Post Intervention 2 (9 months)71.6 units on a scaleStandard Error 2.5
Primary

Change in Communication Participation Item Bank (CPIB)

Communication Participation Item Bank is a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'. Higher scores indicate greater severity of communication challenges. We are reporting on change in CPIB scores using T-scores. The Communicative Participation Item Bank (CPIB) T-score range is as follows: T57.5 and above: Represents a normal experience of communicative participation or minimal problems T57.5-T45: Represents mild challenges T45-T35: Represents moderate challenges T35 and below: Represents severe challenges The CPIB is a patient-reported instrument that measures communicative participation. The mean T-score is 50, and the standard deviation is 10. Higher scores are more favorable, indicating less interference in participation. The ideal score, or someone who reports no problems with communicative participation, would be a T-score of 74.3

Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

Population: the number analyzed in some rows differs from the overall number analyzed due to participant withdrawal and missing data.

ArmMeasureGroupValue (MEAN)Dispersion
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Item Bank (CPIB)Six Months45.6 units on a scaleStandard Error 1
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Item Bank (CPIB)Post Intervention 2 (9 months)46.0 units on a scaleStandard Error 0.9
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Item Bank (CPIB)Baseline46.0 units on a scaleStandard Error 0.8
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Item Bank (CPIB)Post Intervention 1 (3 months)47.4 units on a scaleStandard Error 0.9
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Item Bank (CPIB)12 Months45.5 units on a scaleStandard Error 1
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Item Bank (CPIB)Baseline47.1 units on a scaleStandard Error 1
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Item Bank (CPIB)Six Months46.8 units on a scaleStandard Error 1.1
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Item Bank (CPIB)12 Months45.0 units on a scaleStandard Error 1
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Item Bank (CPIB)Post Intervention 2 (9 months)46.3 units on a scaleStandard Error 1
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Item Bank (CPIB)Post Intervention 1 (3 months)47.7 units on a scaleStandard Error 1.9
Primary

Change in Communication Participation Person Centered Goals

This measure assesses progress toward communication participation goals using Goal Attainment Scaling (GAS). Participants developed personalized goals, each set to a baseline value of '0'. Progress was tracked using a 7-point scale, where -3 represents 'no longer participating' and +3 represents 'exceeded goal'. Higher scores indicate better progress toward goal achievement. Goals were evaluated at 3, 6, 9, and 12 months, with the results reported as the percentage of goals that: Worsened (scores of -1, -2, or -3) No change (score remained at 0) Improved (scores of +1, +2, or +3), including getting close to, reaching, or exceeding the goal. The table below presents the percentage of goals falling into each of these categories at each assessment point.

Time frame: 4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

ArmMeasureGroupValue (NUMBER)
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsSix Months - (Worse than baseline)16.3 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 2 - (Getting close to, reached or exceeded expected goal)62.0 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsSix Months - (Getting close to , reached, or exceeded expected goal)60.1 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered Goals12 Months (Worse than baseline)21.3 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 1 - (Getting close to, reached, or exceed) goal66.7 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered Goals12 Months - (No change from baseline)18.0 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 2 - (Worse than baseline)16.0 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered Goals12 Months - (Getting close to, reached or exceeded expected goal)60.7 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsSix Months - (No change from baseline)23.5 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 2 - (No change from baseline)22.0 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 1 - (No change from baseline)29.6 percentage of goals
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 1 - (Worse than baseline)3.8 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 1 - (No change from baseline)44.0 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 1 - (Getting close to, reached, or exceed) goal49.1 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsSix Months - (Worse than baseline)18.0 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsSix Months - (No change from baseline)35.0 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsSix Months - (Getting close to , reached, or exceeded expected goal)47.0 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 2 - (Worse than baseline)18.8 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 2 - (No change from baseline)26.5 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 2 - (Getting close to, reached or exceeded expected goal)54.7 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered Goals12 Months (Worse than baseline)20.2 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered Goals12 Months - (No change from baseline)23.7 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered Goals12 Months - (Getting close to, reached or exceeded expected goal)56.1 percentage of goals
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Communication Participation Person Centered GoalsPost Intervention 1 - (Worse than baseline)6.9 percentage of goals
Other Pre-specified

Change in Script Accuracy (Trained Scripts)

proportion of participants accuracy on trained scripts. Higher values indicate greater level of script performance as a proportion. Range 0 - 1.

Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Script Accuracy (Trained Scripts)Post Intervention 1 (PIE1) (3 months)0.59 proportion of accuracyStandard Error 0.05
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Script Accuracy (Trained Scripts)12 Months0.60 proportion of accuracyStandard Error 0.05
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Script Accuracy (Trained Scripts)Post Intervention 2 (PIE2) (9 months)0.66 proportion of accuracyStandard Error 0.04
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Script Accuracy (Trained Scripts)Six Months0.60 proportion of accuracyStandard Error 0.05
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Script Accuracy (Trained Scripts)Baseline0.23 proportion of accuracyStandard Error 0.03
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Script Accuracy (Trained Scripts)Six Months0.62 proportion of accuracyStandard Error 0.06
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Script Accuracy (Trained Scripts)Baseline0.27 proportion of accuracyStandard Error 0.03
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Script Accuracy (Trained Scripts)Post Intervention 1 (PIE1) (3 months)0.64 proportion of accuracyStandard Error 0.06
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Script Accuracy (Trained Scripts)Post Intervention 2 (PIE2) (9 months)0.70 proportion of accuracyStandard Error 0.05
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Script Accuracy (Trained Scripts)12 Months0.55 proportion of accuracyStandard Error 0.06
Other Pre-specified

Change in Word Accuracy (Trained Words)

proportion of participants accuracy on trained words. Higher values indicate greater number of words produced after first prompt. Range 0 - 30

Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Word Accuracy (Trained Words)Post Intervention 1 (PIE1) (3 months)25.2 wordsStandard Error 0.8
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Word Accuracy (Trained Words)Post Intervention 2 (PIE2) (9 months)25.1 wordsStandard Error 0.9
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Word Accuracy (Trained Words)Six Months23.6 wordsStandard Error 1
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Word Accuracy (Trained Words)12 months22.7 wordsStandard Error 1.1
Communication Bridge™ (Person With Primary Progressive Aphasia)Change in Word Accuracy (Trained Words)Baseline18.2 wordsStandard Error 1
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Word Accuracy (Trained Words)12 months21.8 wordsStandard Error 1.2
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Word Accuracy (Trained Words)Baseline13.6 wordsStandard Error 1.1
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Word Accuracy (Trained Words)Post Intervention 1 (PIE1) (3 months)25.1 wordsStandard Error 1
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Word Accuracy (Trained Words)Six Months23.5 wordsStandard Error 1
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)Change in Word Accuracy (Trained Words)Post Intervention 2 (PIE2) (9 months)23.7 wordsStandard Error 1.1

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026