Development of Software to Provide the SpeechVive Device Via the Internet
18. september 2019 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
143
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Indiana
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Lafayette, Indiana, Forente stater, 47905
- SpeechVive, Inc
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West Lafayette, Indiana, Forente stater, 47907
- Purdue University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Caregiver Quality of Life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Speech rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At the end of the study period (after 6 months)
|
Survey requesting ratings of satisfaction with the telemedicine application and treatment process
|
At the end of the study period (after 6 months)
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Patient with PD satisfaction - in person group
Tidsramme: At the end of the study period (after 6 months)
|
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
Tidsramme: 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
|
At the end of the study period (after 6 months)
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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. januar 2018
Primær fullføring (Faktiske)
15. juni 2019
Studiet fullført (Faktiske)
15. juni 2019
Datoer for studieregistrering
Først innsendt
6. april 2016
Først innsendt som oppfylte QC-kriteriene
19. april 2016
Først lagt ut (Anslag)
20. april 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1R44DC014867-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .