Clinical trial NCT02744911: Development of Software to Provide the SpeechVive Device Via the Internet
Official title: Development of a Telehealth Platform for Treatment With the SpeechVive Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: speech problems
Lead sponsor: SpeechVive, Inc
Sponsor class: INDUSTRY
Collaborators: name: Purdue University
First posted: 2016-04-20
Enrollment: 143
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Change in Caregiver Quality of Life
timeFrame: Change from baseline after 6 months of treatment
measure: Depression: Caregiver Geriatric Depression Scale
timeFrame: Change from baseline after 6 months of treatment
measure: Change in Patient with PD Ratings of Communication Competence
timeFrame: Change from baseline after 6 months of treatment
measure: Change in Patient with PD quality of life
timeFrame: Change from baseline after 6 months of treatment
measure: Attractiveness of the telehealth platform.
timeFrame: At monthly intervals during the study period (6 months for each patient)
measure: Travel cost burden - in-person group
timeFrame: At monthly intervals during the study period (6 months for each patient)
measure: Impact of treatment on time - telemedicine group
timeFrame: At monthly intervals during the study period (6 months for each patient)
measure: Treatment adherence
timeFrame: At monthly intervals during the study period (6 months for each patient)
measure: Change in Vocal intensity level
timeFrame: Change from baseline after 6 months of treatment
measure: Change in Patient with PD Depression Level
timeFrame: Change from baseline after 6 months of treatment
measure: Impact of Life Events for Patient with PD and Caregiver
timeFrame: Change from baseline after 6 months of treatment
measure: Change in general self-efficacy
timeFrame: Change from baseline after 6 months of treatment
Secondary outcomes:
measure: Change in Speech rate
timeFrame: Change from baseline after 6 months of treatment
measure: Change in Pausing patterns
timeFrame: Change from baseline after 6 months of treatment
measure: Change in Caregiver Burden
timeFrame: Change from baseline after 6 months of treatment
measure: Change in Apathy
timeFrame: Change in baseline after 6 months of treatment for Patient with PD and Caregiver
measure: Change in Caregiver Ratings Patient's of Communication Competence
timeFrame: Change in baseline after 6 months of treatment
measure: Change in Patient with PD Participation in Social Activities
timeFrame: Change in baseline after 6 months of treatment
measure: Change in Patient with PD Participation in Social Activities
timeFrame: Change in baseline after 6 months of treatment
measure: Change in Patient with PD Perceived Autonomy
timeFrame: Change in baseline after 6 months of treatment
measure: Patient with PD satisfaction - telemedicine group
timeFrame: At the end of the study period (after 6 months)
measure: Caregiver satisfaction - telemedicine group
timeFrame: At the end of the study period (after 6 months)
measure: Patient with PD satisfaction - in person group
timeFrame: At the end of the study period (after 6 months)
measure: Caregiver satisfaction - in person group
timeFrame: At the end of the study period (after 6 months)
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: SpeechVive, Inc
state: Indiana
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
citation: Stathopoulos ET, Huber JE, Richardson K, Kamphaus J, DeCicco D, Darling M, Fulcher K, Sussman JE. Increased vocal intensity due to the Lombard effect in speakers with Parkinson's disease: simultaneous laryngeal and respiratory strategies. J Commun Disord. 2014 Mar-Apr;48:1-17. doi: 10.1016/j.jcomdis.2013.12.001. Epub 2013 Dec 28.
citation: Huber JE, Darling M, Francis EJ, Zhang D. Impact of typical aging and Parkinson's disease on the relationship among breath pausing, syntax, and punctuation. Am J Speech Lang Pathol. 2012 Nov;21(4):368-79. doi: 10.1044/1058-0360(2012/11-0059). Epub 2012 Jul 30.
citation: Darling M, Huber JE. Changes to articulatory kinematics in response to loudness cues in individuals with Parkinson's disease. J Speech Lang Hear Res. 2011 Oct;54(5):1247-59. doi: 10.1044/1092-4388(2011/10-0024). Epub 2011 Mar 8.
citation: Huber JE, Darling M. Effect of Parkinson's disease on the production of structured and unstructured speaking tasks: respiratory physiologic and linguistic considerations. J Speech Lang Hear Res. 2011 Feb;54(1):33-46. doi: 10.1044/1092-4388(2010/09-0184). Epub 2010 Sep 15.
citation: Sadagopan N, Huber JE. Effects of loudness cues on respiration in individuals with Parkinson's disease. Mov Disord. 2007 Apr 15;22(5):651-9. doi: 10.1002/mds.21375.