Development of Software to Provide the SpeechVive Device Via the Internet

Study Overview
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Brief Summary
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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.

Official Title
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Development of a Telehealth Platform for Treatment With the SpeechVive Device

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: SpeechVive device
* Behavioral: Telemedicine interaction
* Behavioral: In person interaction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Parkinson's disease Difficulty communicating Is currently being seen, or agrees to be seen, by a speech pathologist who fits the SpeechVive device and also has agreed to participate in the study Has a regular caregiver living with him/her Exclusion Criteria: Neurological diagnoses (except Parkinson's disease) Bilateral hearing aids (since one free ear is required for use of the SpeechVive device)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine group<br>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. | Device: SpeechVive device<br>* 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.<br>Behavioral: Telemedicine interaction<br>* Participants will interact with the speech-language pathologist using the telemedicine platform from their home.<br>|
| Active Comparator: In person group<br>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. | Device: SpeechVive device<br>* 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.<br>Behavioral: In person interaction<br>* Participants will interact with the speech-language pathologist in-person at the speech pathologist's office<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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speech problems