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| Name | Class |
|---|---|
| Purdue University | OTHER |
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Telehealth, increasingly recognized in the neurology field as a solution to access issues for people with Parkinson's disease, improves access to speech therapy, particularly those living in rural areas or with travel barriers. The SpeechVive device, developed by SpeechVive, Inc., is a treatment solution that is easy to use and effective. In an NIH funded study, the SpeechVive device improved communication in 90% of individuals with PD by improving volume, articulation, and speech rate. The investigators propose to eliminate the one drawback of the SpeechVive device, namely that it currently must be programmed by a speech-language pathologist for each patient in person. The overall goal of this project is to develop a telehealth platform for the SpeechVive device that will enable video conferencing for treatment and remote programming of the SpeechVive device for each patient. Once the platform has been developed, the investigators will conduct a study to examine effectiveness and the patient and caregiver satisfaction with telepractice using the SpeechVive device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine group | Experimental | People with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device via the internet using the telemedicine application. Also includes speech-language pathologists providing treatment via the telemedicine application. |
|
| In person group | Active Comparator | People with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device in person. Also includes speech-language pathologists providing treatment in person. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpeechVive device | Device | The SpeechVive is a wearable device that plays multi-talker babble noise in one ear while the person wearing it is talking. The noise is voice-activated (only present when the person speaks). The noise does not interfere with the ability to hear communication partners. The noise coming from the device functions as a natural external cue for people with Parkinson's disease to talk more loudly and clearly. Treatment will involve asking the participants to wear the device daily during the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiver Quality of Life | Scale of Quality of Life of Care-givers | Change from baseline after 6 months of treatment |
| Depression: Caregiver Geriatric Depression Scale | Geriatric Depression Scale | Change from baseline after 6 months of treatment |
| Change in Patient with PD Ratings of Communication Competence | Communicative Participation Item Bank-Short Form | Change from baseline after 6 months of treatment |
| Change in Patient with PD quality of life | Parkinson's Disease Questionnaire-39 | Change from baseline after 6 months of treatment |
| Attractiveness of the telehealth platform. | Survey requesting SLP data regarding patients seen during the study period and adoption of the telepractice model by patients | At monthly intervals during the study period (6 months for each patient) |
| Travel cost burden - in-person group | Survey requesting Patient/caregiver travel distances and durations | At monthly intervals during the study period (6 months for each patient) |
| Impact of treatment on time - telemedicine group | Survey requesting Patient and caregiver reports of time spent before and after sessions preparing and setting up equipment and clearing equipment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Speech rate | Rate of speech from speech samples with and without the device in place | Change from baseline after 6 months of treatment |
| Change in Pausing patterns | Number and duration of silent and filled pauses from speech samples with and without the device in place |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SpeechVive, Inc | Lafayette | Indiana | 47905 | United States | ||
| Purdue University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24438910 | Background | Stathopoulos ET, Huber JE, Richardson K, Kamphaus J, DeCicco D, Darling M, Fulcher K, Sussman JE. Increased vocal intensity due to the Lombard effect in speakers with Parkinson's disease: simultaneous laryngeal and respiratory strategies. J Commun Disord. 2014 Mar-Apr;48:1-17. doi: 10.1016/j.jcomdis.2013.12.001. Epub 2013 Dec 28. | |
| 22846880 | Background | Huber JE, Darling M, Francis EJ, Zhang D. Impact of typical aging and Parkinson's disease on the relationship among breath pausing, syntax, and punctuation. Am J Speech Lang Pathol. 2012 Nov;21(4):368-79. doi: 10.1044/1058-0360(2012/11-0059). Epub 2012 Jul 30. |
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The data from the people with Parkinson's disease and their caregivers will include limited financial information, perceptions of speech telepractice, survey data, and some objective measurements of speech production. Once de-identified and published in peer-reviewed journals, these data will be made available upon request. Any researcher requesting access to these data will need to submit the following to Jessica Huber:
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Telemedicine interaction | Behavioral | Participants will interact with the speech-language pathologist using the telemedicine platform from their home. |
|
| In person interaction | Behavioral | Participants will interact with the speech-language pathologist in-person at the speech pathologist's office |
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| At monthly intervals during the study period (6 months for each patient) |
| Treatment adherence | Usage data from the SpeechVive and patient attendance at treatment sessions | At monthly intervals during the study period (6 months for each patient) |
| Change in Vocal intensity level | Sound pressure level from speech samples with and without the device in place | Change from baseline after 6 months of treatment |
| Change in Patient with PD Depression Level | Geriatric Depression Scale Short form | Change from baseline after 6 months of treatment |
| Impact of Life Events for Patient with PD and Caregiver | Change in Impact of PD on life satisfaction | Change from baseline after 6 months of treatment |
| Change in general self-efficacy | Self-efficacy for people with disabilities scale | Change from baseline after 6 months of treatment |
| Change from baseline after 6 months of treatment |
| Change in Caregiver Burden | Caregiver Burden Inventory | Change from baseline after 6 months of treatment |
| Change in Apathy | Apathy Scale | Change in baseline after 6 months of treatment for Patient with PD and Caregiver |
| Change in Caregiver Ratings Patient's of Communication Competence | Communicative Participation Item Bank-Short Form | Change in baseline after 6 months of treatment |
| Change in Patient with PD Participation in Social Activities | Quality of Life in Neurological Disorders (Neuro-QOL) | Change in baseline after 6 months of treatment |
| Change in Patient with PD Participation in Social Activities | Ability to Participate in Social Roles and Activities-Short Form | Change in baseline after 6 months of treatment |
| Change in Patient with PD Perceived Autonomy | 7-item Autonomy Subscale of the Basic Psychological Needs Scale | Change in baseline after 6 months of treatment |
| Patient with PD satisfaction - telemedicine group | Survey requesting ratings of satisfaction with the telemedicine application and treatment process | At the end of the study period (after 6 months) |
| Caregiver satisfaction - telemedicine group | Survey requesting ratings of satisfaction with the telemedicine application and treatment process | At the end of the study period (after 6 months) |
| Patient with PD satisfaction - in person group | Survey requesting ratings of satisfaction with the in-person treatment process | At the end of the study period (after 6 months) |
| Caregiver satisfaction - in person group | Survey requesting ratings of satisfaction with the in-person treatment process | At the end of the study period (after 6 months) |
| West Lafayette |
| Indiana |
| 47907 |
| United States |
| 21386044 | Background | Darling M, Huber JE. Changes to articulatory kinematics in response to loudness cues in individuals with Parkinson's disease. J Speech Lang Hear Res. 2011 Oct;54(5):1247-59. doi: 10.1044/1092-4388(2011/10-0024). Epub 2011 Mar 8. |
| 20844256 | Background | Huber JE, Darling M. Effect of Parkinson's disease on the production of structured and unstructured speaking tasks: respiratory physiologic and linguistic considerations. J Speech Lang Hear Res. 2011 Feb;54(1):33-46. doi: 10.1044/1092-4388(2010/09-0184). Epub 2010 Sep 15. |
| 17266087 | Background | Sadagopan N, Huber JE. Effects of loudness cues on respiration in individuals with Parkinson's disease. Mov Disord. 2007 Apr 15;22(5):651-9. doi: 10.1002/mds.21375. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |