Development of a Telehealth Platform for Treatment With the SpeechVive Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- SpeechVive, Inc
- Enrollment
- 143
- Locations
- 2
- Primary Endpoint
- Change in Caregiver Quality of Life
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Change in Caregiver Quality of Life
Time Frame: Change from baseline after 6 months of treatment
Scale of Quality of Life of Care-givers
Depression: Caregiver Geriatric Depression Scale
Time Frame: Change from baseline after 6 months of treatment
Geriatric Depression Scale
Change in Patient with PD Ratings of Communication Competence
Time Frame: Change from baseline after 6 months of treatment
Communicative Participation Item Bank-Short Form
Change in Patient with PD quality of life
Time Frame: Change from baseline after 6 months of treatment
Parkinson's Disease Questionnaire-39
Attractiveness of the telehealth platform.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Change from baseline after 6 months of treatment
Geriatric Depression Scale Short form
Impact of Life Events for Patient with PD and Caregiver
Time Frame: Change from baseline after 6 months of treatment
Change in Impact of PD on life satisfaction
Change in general self-efficacy
Time Frame: Change from baseline after 6 months of treatment
Self-efficacy for people with disabilities scale
Secondary Outcomes
- Change in Speech rate(Change from baseline after 6 months of treatment)
- Change in Apathy(Change in baseline after 6 months of treatment for Patient with PD and Caregiver)
- Change in Pausing patterns(Change from baseline after 6 months of treatment)
- Change in Caregiver Burden(Change from baseline after 6 months of treatment)
- Change in Caregiver Ratings Patient's of Communication Competence(Change in baseline after 6 months of treatment)
- Change in Patient with PD Participation in Social Activities(Change in baseline after 6 months of treatment)
- Change in Patient with PD Perceived Autonomy(Change in baseline after 6 months of treatment)
- Patient with PD satisfaction - telemedicine group(At the end of the study period (after 6 months))
- Caregiver satisfaction - telemedicine group(At the end of the study period (after 6 months))
- Patient with PD satisfaction - in person group(At the end of the study period (after 6 months))
- Caregiver satisfaction - in person group(At the end of the study period (after 6 months))