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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
143
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.
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office
SpeechVive, Inc
Lafayette, Indiana, United States
Purdue University
West Lafayette, Indiana, United States
Change in Caregiver Quality of Life
Scale of Quality of Life of Care-givers
Time frame: Change from baseline after 6 months of treatment
Depression: Caregiver Geriatric Depression Scale
Geriatric Depression Scale
Time frame: Change from baseline after 6 months of treatment
Change in Patient with PD Ratings of Communication Competence
Communicative Participation Item Bank-Short Form
Time frame: Change from baseline after 6 months of treatment
Change in Patient with PD quality of life
Parkinson's Disease Questionnaire-39
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline after 6 months of treatment
Change in Patient with PD Depression Level
Geriatric Depression Scale Short form
Time frame: 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
Time frame: Change from baseline after 6 months of treatment
Change in general self-efficacy
Self-efficacy for people with disabilities scale
Time frame: Change from baseline after 6 months of treatment
Change in Speech rate
Rate of speech from speech samples with and without the device in place
Time frame: 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
Time frame: Change from baseline after 6 months of treatment
Change in Caregiver Burden
Caregiver Burden Inventory
Time frame: Change from baseline after 6 months of treatment
Change in Apathy
Apathy Scale
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Change in baseline after 6 months of treatment
Patient with PD satisfaction - telemedicine group
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Survey requesting ratings of satisfaction with the telemedicine application and treatment process
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the end of the study period (after 6 months)