Development of Software to Provide the SpeechVive Device Via the Internet
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SpeechVive device
Telemedicine interaction
In person interaction
Sponsored by
About this trial
This is an interventional health services research trial for Parkinson Disease focused on measuring speech problems
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)
Sites / Locations
- SpeechVive, Inc
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telemedicine group
In person group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Caregiver Quality of Life
Scale of Quality of Life of Care-givers
Depression: Caregiver Geriatric Depression Scale
Geriatric Depression Scale
Change in Patient with PD Ratings of Communication Competence
Communicative Participation Item Bank-Short Form
Change in Patient with PD quality of life
Parkinson's Disease Questionnaire-39
Attractiveness of the telehealth platform.
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
Survey requesting Patient/caregiver travel distances and durations
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
Treatment adherence
Usage data from the SpeechVive and patient attendance at treatment sessions
Change in Vocal intensity level
Sound pressure level from speech samples with and without the device in place
Change in Patient with PD Depression Level
Geriatric Depression Scale Short form
Impact of Life Events for Patient with PD and Caregiver
Change in Impact of PD on life satisfaction
Change in general self-efficacy
Self-efficacy for people with disabilities scale
Secondary Outcome Measures
Change in Speech rate
Rate of speech from speech samples with and without the device in place
Change in Pausing patterns
Number and duration of silent and filled pauses from speech samples with and without the device in place
Change in Caregiver Burden
Caregiver Burden Inventory
Change in Apathy
Apathy Scale
Change in Caregiver Ratings Patient's of Communication Competence
Communicative Participation Item Bank-Short Form
Change in Patient with PD Participation in Social Activities
Quality of Life in Neurological Disorders (Neuro-QOL)
Change in Patient with PD Participation in Social Activities
Ability to Participate in Social Roles and Activities-Short Form
Change in Patient with PD Perceived Autonomy
7-item Autonomy Subscale of the Basic Psychological Needs Scale
Patient with PD satisfaction - telemedicine group
Survey requesting ratings of satisfaction with the telemedicine application and treatment process
Caregiver satisfaction - telemedicine group
Survey requesting ratings of satisfaction with the telemedicine application and treatment process
Patient with PD satisfaction - in person group
Survey requesting ratings of satisfaction with the in-person treatment process
Caregiver satisfaction - in person group
Survey requesting ratings of satisfaction with the in-person treatment process
Full Information
NCT ID
NCT02744911
First Posted
April 6, 2016
Last Updated
September 18, 2019
Sponsor
SpeechVive, Inc
Collaborators
Purdue University
1. Study Identification
Unique Protocol Identification Number
NCT02744911
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SpeechVive, Inc
Collaborators
Purdue University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
speech problems
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine group
Arm Type
Experimental
Arm Description
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.
Arm Title
In person group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SpeechVive device
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine interaction
Intervention Description
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
Intervention Type
Behavioral
Intervention Name(s)
In person interaction
Intervention Description
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office
Primary Outcome Measure Information:
Title
Change in Caregiver Quality of Life
Description
Scale of Quality of Life of Care-givers
Time Frame
Change from baseline after 6 months of treatment
Title
Depression: Caregiver Geriatric Depression Scale
Description
Geriatric Depression Scale
Time Frame
Change from baseline after 6 months of treatment
Title
Change in Patient with PD Ratings of Communication Competence
Description
Communicative Participation Item Bank-Short Form
Time Frame
Change from baseline after 6 months of treatment
Title
Change in Patient with PD quality of life
Description
Parkinson's Disease Questionnaire-39
Time Frame
Change from baseline after 6 months of treatment
Title
Attractiveness of the telehealth platform.
Description
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)
Title
Travel cost burden - in-person group
Description
Survey requesting Patient/caregiver travel distances and durations
Time Frame
At monthly intervals during the study period (6 months for each patient)
Title
Impact of treatment on time - telemedicine group
Description
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)
Title
Treatment adherence
Description
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)
Title
Change in Vocal intensity level
Description
Sound pressure level from speech samples with and without the device in place
Time Frame
Change from baseline after 6 months of treatment
Title
Change in Patient with PD Depression Level
Description
Geriatric Depression Scale Short form
Time Frame
Change from baseline after 6 months of treatment
Title
Impact of Life Events for Patient with PD and Caregiver
Description
Change in Impact of PD on life satisfaction
Time Frame
Change from baseline after 6 months of treatment
Title
Change in general self-efficacy
Description
Self-efficacy for people with disabilities scale
Time Frame
Change from baseline after 6 months of treatment
Secondary Outcome Measure Information:
Title
Change in Speech rate
Description
Rate of speech from speech samples with and without the device in place
Time Frame
Change from baseline after 6 months of treatment
Title
Change in Pausing patterns
Description
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
Title
Change in Caregiver Burden
Description
Caregiver Burden Inventory
Time Frame
Change from baseline after 6 months of treatment
Title
Change in Apathy
Description
Apathy Scale
Time Frame
Change in baseline after 6 months of treatment for Patient with PD and Caregiver
Title
Change in Caregiver Ratings Patient's of Communication Competence
Description
Communicative Participation Item Bank-Short Form
Time Frame
Change in baseline after 6 months of treatment
Title
Change in Patient with PD Participation in Social Activities
Description
Quality of Life in Neurological Disorders (Neuro-QOL)
Time Frame
Change in baseline after 6 months of treatment
Title
Change in Patient with PD Participation in Social Activities
Description
Ability to Participate in Social Roles and Activities-Short Form
Time Frame
Change in baseline after 6 months of treatment
Title
Change in Patient with PD Perceived Autonomy
Description
7-item Autonomy Subscale of the Basic Psychological Needs Scale
Time Frame
Change in baseline after 6 months of treatment
Title
Patient with PD satisfaction - telemedicine group
Description
Survey requesting ratings of satisfaction with the telemedicine application and treatment process
Time Frame
At the end of the study period (after 6 months)
Title
Caregiver satisfaction - telemedicine group
Description
Survey requesting ratings of satisfaction with the telemedicine application and treatment process
Time Frame
At the end of the study period (after 6 months)
Title
Patient with PD satisfaction - in person group
Description
Survey requesting ratings of satisfaction with the in-person treatment process
Time Frame
At the end of the study period (after 6 months)
Title
Caregiver satisfaction - in person group
Description
Survey requesting ratings of satisfaction with the in-person treatment process
Time Frame
At the end of the study period (after 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
SpeechVive, Inc
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data from the people with Parkinson's disease and their caregivers will include limited financial information, perceptions of speech telepractice, survey data, and some objective measurements of speech production. Once de-identified and published in peer-reviewed journals, these data will be made available upon request. Any researcher requesting access to these data will need to submit the following to Jessica Huber:
Name and institution of PI
Proof of institutional appointment
Names and roles for all individuals who will access the data for the planned analysis
Detailed plan for the use of the data
Timeline for use and publication of the analyses If Dr. Huber approves the data use, the PI must sign a license with Purdue University's Office of Technology Commercialization promising to keep the data confidential, to not share it with anyone not named in the application above, and to destroy the data once analysis is complete.
Citations:
PubMed Identifier
24438910
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.
Results Reference
background
PubMed Identifier
22846880
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.
Results Reference
background
PubMed Identifier
21386044
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.
Results Reference
background
PubMed Identifier
20844256
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.
Results Reference
background
PubMed Identifier
17266087
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.
Results Reference
background
Links:
URL
https://www.purdue.edu/motorspeechlab/for-participants/
Description
information about participating in studies through the Purdue Motor Speech Laboratory
Learn more about this trial
Development of Software to Provide the SpeechVive Device Via the Internet
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