An interventional study of Communication Bridge™ in Aphasia, Primary Progressive Aphasia and Dementia, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by University of Chicago · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 8 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
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Exclusion Criteria:
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.
Behavioral: Communication Bridge™
Evidence-based speech language therapy treatment will be compared and contrasted.
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
| Milestone | Experimental: Communication Bridge™ (PPA Participants) | Experimental: Communication Bridge™ (Care Partners) |
|---|---|---|
| Started | 4 | 4 |
| Completed | 4 | 4 |
| Not completed | 0 | 0 |
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)
| score on a scale | Experimental: Communication Bridge™ (PPA Participants) |
|---|---|
| Block 4 Evaluation (Baseline) | 64.32 ± 8.60 |
| Post-Intervention Evaluation 4 (at 2 months) | 65.91 ± 6.90 |
| Block 5 Evaluation (at 6 months) | 63.00 ± 8.31 |
| Post-Intervention Evaluation 5 (at 8 months) | 64.77 ± 9.72 |
| Block 6 Evaluation (at 12 months) | 61.36 ± 12.19 |
Collected over Adverse event data were collected over a period of 1 year from the participant's enrollment at baseline.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Communication Bridge™ (PPA Participants) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) |
| Experimental: Communication Bridge™ (Care Partners) | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Event | Experimental: Communication Bridge™ (PPA Participants) | Experimental: Communication Bridge™ (Care Partners) |
|---|---|---|
| Medical EventSurgical and medical procedures | 1/4 | 0/4 |
| Event | Experimental: Communication Bridge™ (PPA Participants) | Experimental: Communication Bridge™ (Care Partners) |
|---|---|---|
| Other psychosocial eventsPsychiatric disorders | 0/4 | 2/4 |
| medical event (non serious)Musculoskeletal and connective tissue disorders | 1/4 | 0/4 |
| Age, Categorical(Participants) | Experimental: Communication Bridge™ (PPA Participants) | Experimental: Communication Bridge™ (Care-Partners) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 4 | 4 | 8 |
| Sex: Female, Male(Participants) | Experimental: Communication Bridge™ (PPA Participants) | Experimental: Communication Bridge™ (Care-Partners) | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 2 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Experimental: Communication Bridge™ (PPA Participants) | Experimental: Communication Bridge™ (Care-Partners) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 4 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Experimental: Communication Bridge™ (PPA Participants) | Experimental: Communication Bridge™ (Care-Partners) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 4 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Highest Degree Earned(Participants) | Experimental: Communication Bridge™ (PPA Participants) | Experimental: Communication Bridge™ (Care-Partners) | Total |
|---|---|---|---|
| Did not complete high school | 0 | 0 | 0 |
| High School/GED | 0 | 1 | 1 |
| Some College | 0 | 2 | 2 |
| Bachelor's Degree | 3 | 0 | 3 |
| Master's Degree | 1 | 1 | 2 |
| Advanced Graduate/Phd | 0 | 0 | 0 |
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