Parkinson Disease
Conditions
Keywords
speech problems
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.
Interventions
DEVICESpeechVive 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.
BEHAVIORALTelemedicine interaction
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
BEHAVIORALIn person interaction
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office
Sponsors
Purdue University
SpeechVive, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in general self-efficacy | Change from baseline after 6 months of treatment | Self-efficacy for people with disabilities scale |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Quality of Life in Neurological Disorders (Neuro-QOL) |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed