Development of Software to Provide the SpeechVive Device Via the Internet
18 september 2019 uppdaterad av: SpeechVive, Inc
Development of a Telehealth Platform for Treatment With the SpeechVive Device
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
143
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Indiana
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Lafayette, Indiana, Förenta staterna, 47905
- SpeechVive, Inc
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West Lafayette, Indiana, Förenta staterna, 47907
- Purdue University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
30 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Telemedicine group
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.
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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.
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Aktiv komparator: In person group
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.
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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 in-person at the speech pathologist's office
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Caregiver Quality of Life
Tidsram: Change from baseline after 6 months of treatment
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Scale of Quality of Life of Care-givers
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Change from baseline after 6 months of treatment
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Depression: Caregiver Geriatric Depression Scale
Tidsram: Change from baseline after 6 months of treatment
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Geriatric Depression Scale
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Change from baseline after 6 months of treatment
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Change in Patient with PD Ratings of Communication Competence
Tidsram: Change from baseline after 6 months of treatment
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Communicative Participation Item Bank-Short Form
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Change from baseline after 6 months of treatment
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Change in Patient with PD quality of life
Tidsram: Change from baseline after 6 months of treatment
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Parkinson's Disease Questionnaire-39
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Change from baseline after 6 months of treatment
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Attractiveness of the telehealth platform.
Tidsram: At monthly intervals during the study period (6 months for each patient)
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Survey requesting SLP data regarding patients seen during the study period and adoption of the telepractice model by patients
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At monthly intervals during the study period (6 months for each patient)
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Travel cost burden - in-person group
Tidsram: At monthly intervals during the study period (6 months for each patient)
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Survey requesting Patient/caregiver travel distances and durations
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At monthly intervals during the study period (6 months for each patient)
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Impact of treatment on time - telemedicine group
Tidsram: At monthly intervals during the study period (6 months for each patient)
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Survey requesting Patient and caregiver reports of time spent before and after sessions preparing and setting up equipment and clearing equipment
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At monthly intervals during the study period (6 months for each patient)
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Treatment adherence
Tidsram: At monthly intervals during the study period (6 months for each patient)
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Usage data from the SpeechVive and patient attendance at treatment sessions
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At monthly intervals during the study period (6 months for each patient)
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Change in Vocal intensity level
Tidsram: Change from baseline after 6 months of treatment
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Sound pressure level from speech samples with and without the device in place
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Change from baseline after 6 months of treatment
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Change in Patient with PD Depression Level
Tidsram: Change from baseline after 6 months of treatment
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Geriatric Depression Scale Short form
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Change from baseline after 6 months of treatment
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Impact of Life Events for Patient with PD and Caregiver
Tidsram: Change from baseline after 6 months of treatment
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Change in Impact of PD on life satisfaction
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Change from baseline after 6 months of treatment
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Change in general self-efficacy
Tidsram: Change from baseline after 6 months of treatment
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Self-efficacy for people with disabilities scale
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Change from baseline after 6 months of treatment
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Speech rate
Tidsram: Change from baseline after 6 months of treatment
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Rate of speech from speech samples with and without the device in place
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Change from baseline after 6 months of treatment
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Change in Pausing patterns
Tidsram: Change from baseline after 6 months of treatment
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Number and duration of silent and filled pauses from speech samples with and without the device in place
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Change from baseline after 6 months of treatment
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Change in Caregiver Burden
Tidsram: Change from baseline after 6 months of treatment
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Caregiver Burden Inventory
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Change from baseline after 6 months of treatment
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Change in Apathy
Tidsram: Change in baseline after 6 months of treatment for Patient with PD and Caregiver
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Apathy Scale
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Change in baseline after 6 months of treatment for Patient with PD and Caregiver
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Change in Caregiver Ratings Patient's of Communication Competence
Tidsram: Change in baseline after 6 months of treatment
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Communicative Participation Item Bank-Short Form
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Change in baseline after 6 months of treatment
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Change in Patient with PD Participation in Social Activities
Tidsram: Change in baseline after 6 months of treatment
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Quality of Life in Neurological Disorders (Neuro-QOL)
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Change in baseline after 6 months of treatment
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Change in Patient with PD Participation in Social Activities
Tidsram: Change in baseline after 6 months of treatment
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Ability to Participate in Social Roles and Activities-Short Form
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Change in baseline after 6 months of treatment
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Change in Patient with PD Perceived Autonomy
Tidsram: Change in baseline after 6 months of treatment
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7-item Autonomy Subscale of the Basic Psychological Needs Scale
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Change in baseline after 6 months of treatment
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Patient with PD satisfaction - telemedicine group
Tidsram: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the telemedicine application and treatment process
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At the end of the study period (after 6 months)
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Caregiver satisfaction - telemedicine group
Tidsram: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the telemedicine application and treatment process
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At the end of the study period (after 6 months)
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Patient with PD satisfaction - in person group
Tidsram: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the in-person treatment process
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At the end of the study period (after 6 months)
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Caregiver satisfaction - in person group
Tidsram: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the in-person treatment process
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At the end of the study period (after 6 months)
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Samarbetspartners och utredare
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Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
26 januari 2018
Primärt slutförande (Faktisk)
15 juni 2019
Avslutad studie (Faktisk)
15 juni 2019
Studieregistreringsdatum
Först inskickad
6 april 2016
Först inskickad som uppfyllde QC-kriterierna
19 april 2016
Första postat (Uppskatta)
20 april 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 september 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 september 2019
Senast verifierad
1 september 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1R44DC014867-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
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