Alzheimer Disease, Aphasia, Communication, Dementia, Primary Progressive Aphasia
Conditions
Brief summary
This study will evaluate evidence-based treatments for adults with mild Primary Progressive Aphasia (PPA). The aim of the study is to help identify efficacious communication and quality of life interventions for those with PPA and their care-partners. 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 iPad equipped with the necessary applications and features for the study. Participants will complete evaluations, speech therapy sessions with a speech and language therapist, and sessions with a licensed social worker or related clinician. They will have 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.
Detailed description
This study will evaluate evidence-based treatments for adults with mild Primary Progressive Aphasia (PPA). The aim of the study is to help identify efficacious communication and quality of life interventions for those with PPA and their care-partners. 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 iPad equipped with the necessary applications and features for the study. Participants will complete evaluations, speech therapy sessions with a speech and language therapist, and sessions with a licensed social worker or related clinician. They will have 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
BEHAVIORALCommunication Bridge™
Evidence-based speech language therapy treatment will be compared and contrasted.
Sponsors
National Institute on Aging (NIA)
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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)
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 may be requested and reviewed to determine eligibility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Communication Confidence (CCRSA) | Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | Experimental: Communication Bridge™ (PPA Participants) | Total | Experimental: Communication Bridge™ (Care-Partners) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 8 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Highest Degree Earned Advanced Graduate/Phd | 0 Participants | 0 Participants | 0 Participants |
| Highest Degree Earned Bachelor's Degree | 3 Participants | 3 Participants | 0 Participants |
| Highest Degree Earned Did not complete high school | 0 Participants | 0 Participants | 0 Participants |
| Highest Degree Earned High School/GED | 0 Participants | 1 Participants | 1 Participants |
| Highest Degree Earned Master's Degree | 1 Participants | 2 Participants | 1 Participants |
| Highest Degree Earned Some College | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 1 / 4 | 2 / 4 |
| serious Total, serious adverse events | 1 / 4 | 0 / 4 |
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. (Note Primary Outcome Measure was not collected for care-partners)
Time frame: Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Communication Bridge™ (PPA Participants) | Change in Communication Confidence (CCRSA) | Block 4 Evaluation (Baseline) | 64.32 score on a scale | Standard Deviation 8.6 |
| Experimental: Communication Bridge™ (PPA Participants) | Change in Communication Confidence (CCRSA) | Post-Intervention Evaluation 4 (at 2 months) | 65.91 score on a scale | Standard Deviation 6.9 |
| Experimental: Communication Bridge™ (PPA Participants) | Change in Communication Confidence (CCRSA) | Block 5 Evaluation (at 6 months) | 63.00 score on a scale | Standard Deviation 8.31 |
| Experimental: Communication Bridge™ (PPA Participants) | Change in Communication Confidence (CCRSA) | Post-Intervention Evaluation 5 (at 8 months) | 64.77 score on a scale | Standard Deviation 9.72 |
| Experimental: Communication Bridge™ (PPA Participants) | Change in Communication Confidence (CCRSA) | Block 6 Evaluation (at 12 months) | 61.36 score on a scale | Standard Deviation 12.19 |