Development of Software to Provide the SpeechVive Device Via the Internet
- Conditions
- Parkinson Disease
- Interventions
- Device: SpeechVive deviceBehavioral: Telemedicine interactionBehavioral: In person interaction
- Registration Number
- NCT02744911
- Lead Sponsor
- SpeechVive, Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
- 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
- Neurological diagnoses (except Parkinson's disease)
- Bilateral hearing aids (since one free ear is required for use of the SpeechVive device)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemedicine group SpeechVive device 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. Telemedicine group Telemedicine interaction 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 In person interaction 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. In person group SpeechVive device 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.
- Primary Outcome Measures
Name Time Method Change in Caregiver Quality of Life Change from baseline after 6 months of treatment Scale of Quality of Life of Care-givers
Depression: Caregiver Geriatric Depression Scale Change from baseline after 6 months of treatment Geriatric Depression Scale
Change in Patient with PD Ratings of Communication Competence Change from baseline after 6 months of treatment Communicative Participation Item Bank-Short Form
Change in Patient with PD quality of life Change from baseline after 6 months of treatment Parkinson's Disease Questionnaire-39
Attractiveness of the telehealth platform. At monthly intervals during the study period (6 months for each patient) Survey requesting SLP data regarding patients seen during the study period and adoption of the telepractice model by patients
Travel cost burden - in-person group At monthly intervals during the study period (6 months for each patient) Survey requesting Patient/caregiver travel distances and durations
Impact of treatment on time - telemedicine group At monthly intervals during the study period (6 months for each patient) Survey requesting Patient and caregiver reports of time spent before and after sessions preparing and setting up equipment and clearing equipment
Treatment adherence At monthly intervals during the study period (6 months for each patient) Usage data from the SpeechVive and patient attendance at treatment sessions
Change in Vocal intensity level Change from baseline after 6 months of treatment Sound pressure level from speech samples with and without the device in place
Change in Patient with PD Depression Level Change from baseline after 6 months of treatment Geriatric Depression Scale Short form
Impact of Life Events for Patient with PD and Caregiver Change from baseline after 6 months of treatment Change in Impact of PD on life satisfaction
Change in general self-efficacy Change from baseline after 6 months of treatment Self-efficacy for people with disabilities scale
- Secondary Outcome Measures
Name Time Method Change in Speech rate Change from baseline after 6 months of treatment Rate of speech from speech samples with and without the device in place
Change in Pausing patterns Change from baseline after 6 months of treatment Number and duration of silent and filled pauses from speech samples with and without the device in place
Change in Caregiver Burden Change from baseline after 6 months of treatment Caregiver Burden Inventory
Change in Apathy Change in baseline after 6 months of treatment for Patient with PD and Caregiver Apathy Scale
Change in Caregiver Ratings Patient's of Communication Competence Change in baseline after 6 months of treatment Communicative Participation Item Bank-Short Form
Change in Patient with PD Participation in Social Activities Change in baseline after 6 months of treatment Ability to Participate in Social Roles and Activities-Short Form
Change in Patient with PD Perceived Autonomy Change in baseline after 6 months of treatment 7-item Autonomy Subscale of the Basic Psychological Needs Scale
Patient with PD satisfaction - telemedicine group At the end of the study period (after 6 months) Survey requesting ratings of satisfaction with the telemedicine application and treatment process
Caregiver satisfaction - telemedicine group At the end of the study period (after 6 months) Survey requesting ratings of satisfaction with the telemedicine application and treatment process
Patient with PD satisfaction - in person group At the end of the study period (after 6 months) Survey requesting ratings of satisfaction with the in-person treatment process
Caregiver satisfaction - in person group At the end of the study period (after 6 months) Survey requesting ratings of satisfaction with the in-person treatment process
Trial Locations
- Locations (2)
SpeechVive, Inc
🇺🇸Lafayette, Indiana, United States
Purdue University
🇺🇸West Lafayette, Indiana, United States