Primary Progressive Aphasia
Conditions
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
Study design
Intervention model description
NIH Stage 2 behavioral clinical trial
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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 months | 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. |
| 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 months | 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 |
| Change in Communication Participation Person Centered Goals | 4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 months | proportion 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 months | proportion 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
| Arm | Count |
|---|---|
| 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 |
| Total | 95 |
Baseline characteristics
| Characteristic | Communication Bridge™ (Persons With Primary Progressive Aphasia) | Total | Evidence-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 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 94 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 56 Participants | 93 Participants | 37 Participants |
| Sex: Female, Male Female | 25 Participants | 49 Participants | 24 Participants |
| Sex: Female, Male Male | 31 Participants | 46 Participants | 15 Participants |
| Years of education | 16.2 years STANDARD_DEVIATION 2.5 | 16.4 years STANDARD_DEVIATION 2.4 | 16.7 years STANDARD_DEVIATION 2.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 39 |
| other Total, other adverse events | 5 / 56 | 7 / 39 |
| serious Total, serious adverse events | 7 / 56 | 4 / 39 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Confidence (CCRSA) | Post Intervention 1 (3 months) | 73.7 units on a scale | Standard 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 scale | Standard Error 2.2 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Confidence (CCRSA) | Six Months | 72.1 units on a scale | Standard Error 2.1 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Confidence (CCRSA) | 12 Months | 69.1 units on a scale | Standard Error 2.7 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Confidence (CCRSA) | Baseline | 72.6 units on a scale | Standard Error 1.8 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Communication Confidence (CCRSA) | 12 Months | 70.1 units on a scale | Standard Error 2.5 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Communication Confidence (CCRSA) | Baseline | 72.9 units on a scale | Standard 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 scale | Standard Error 2.4 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Communication Confidence (CCRSA) | Six Months | 73.1 units on a scale | Standard 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 scale | Standard Error 2.5 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Item Bank (CPIB) | Six Months | 45.6 units on a scale | Standard 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 scale | Standard Error 0.9 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Item Bank (CPIB) | Baseline | 46.0 units on a scale | Standard 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 scale | Standard Error 0.9 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Item Bank (CPIB) | 12 Months | 45.5 units on a scale | Standard Error 1 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Communication Participation Item Bank (CPIB) | Baseline | 47.1 units on a scale | Standard Error 1 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Communication Participation Item Bank (CPIB) | Six Months | 46.8 units on a scale | Standard Error 1.1 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Communication Participation Item Bank (CPIB) | 12 Months | 45.0 units on a scale | Standard 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 scale | Standard 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 scale | Standard Error 1.9 |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | Six Months - (Worse than baseline) | 16.3 percentage of goals |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | Post 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 Goals | Six 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 Goals | 12 Months (Worse than baseline) | 21.3 percentage of goals |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | Post Intervention 1 - (Getting close to, reached, or exceed) goal | 66.7 percentage of goals |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | 12 Months - (No change from baseline) | 18.0 percentage of goals |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | Post Intervention 2 - (Worse than baseline) | 16.0 percentage of goals |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | 12 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 Goals | Six Months - (No change from baseline) | 23.5 percentage of goals |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | Post Intervention 2 - (No change from baseline) | 22.0 percentage of goals |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | Post Intervention 1 - (No change from baseline) | 29.6 percentage of goals |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | Post 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 Goals | Post 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 Goals | Post Intervention 1 - (Getting close to, reached, or exceed) goal | 49.1 percentage of goals |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | Six Months - (Worse than baseline) | 18.0 percentage of goals |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | Six 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 Goals | Six 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 Goals | Post 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 Goals | Post 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 Goals | Post 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 Goals | 12 Months (Worse than baseline) | 20.2 percentage of goals |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Communication Participation Person Centered Goals | 12 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 Goals | 12 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 Goals | Post Intervention 1 - (Worse than baseline) | 6.9 percentage of goals |
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
| Arm | Measure | Group | Value (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 accuracy | Standard Error 0.05 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Script Accuracy (Trained Scripts) | 12 Months | 0.60 proportion of accuracy | Standard 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 accuracy | Standard Error 0.04 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Script Accuracy (Trained Scripts) | Six Months | 0.60 proportion of accuracy | Standard Error 0.05 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Script Accuracy (Trained Scripts) | Baseline | 0.23 proportion of accuracy | Standard Error 0.03 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Script Accuracy (Trained Scripts) | Six Months | 0.62 proportion of accuracy | Standard Error 0.06 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Script Accuracy (Trained Scripts) | Baseline | 0.27 proportion of accuracy | Standard 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 accuracy | Standard 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 accuracy | Standard Error 0.05 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Script Accuracy (Trained Scripts) | 12 Months | 0.55 proportion of accuracy | Standard Error 0.06 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Word Accuracy (Trained Words) | Post Intervention 1 (PIE1) (3 months) | 25.2 words | Standard Error 0.8 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Word Accuracy (Trained Words) | Post Intervention 2 (PIE2) (9 months) | 25.1 words | Standard Error 0.9 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Word Accuracy (Trained Words) | Six Months | 23.6 words | Standard Error 1 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Word Accuracy (Trained Words) | 12 months | 22.7 words | Standard Error 1.1 |
| Communication Bridge™ (Person With Primary Progressive Aphasia) | Change in Word Accuracy (Trained Words) | Baseline | 18.2 words | Standard Error 1 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Word Accuracy (Trained Words) | 12 months | 21.8 words | Standard Error 1.2 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Word Accuracy (Trained Words) | Baseline | 13.6 words | Standard 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 words | Standard Error 1 |
| Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) | Change in Word Accuracy (Trained Words) | Six Months | 23.5 words | Standard 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 words | Standard Error 1.1 |