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Development of Software to Provide the SpeechVive Device Via the Internet

18. september 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

143

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Indiana
      • Lafayette, Indiana, Forenede Stater, 47905
        • SpeechVive, Inc
      • West Lafayette, Indiana, Forenede Stater, 47907
        • Purdue University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: SpeechVive device
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.
Adfærdsmæssigt: Telemedicine interaction
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
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.
Enhed: SpeechVive device
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.
Adfærdsmæssigt: In person interaction
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Caregiver Quality of Life
Tidsramme: Change from baseline after 6 months of treatment
Scale of Quality of Life of Care-givers
Change from baseline after 6 months of treatment
Depression: Caregiver Geriatric Depression Scale
Tidsramme: Change from baseline after 6 months of treatment
Geriatric Depression Scale
Change from baseline after 6 months of treatment
Change in Patient with PD Ratings of Communication Competence
Tidsramme: Change from baseline after 6 months of treatment
Communicative Participation Item Bank-Short Form
Change from baseline after 6 months of treatment
Change in Patient with PD quality of life
Tidsramme: Change from baseline after 6 months of treatment
Parkinson's Disease Questionnaire-39
Change from baseline after 6 months of treatment
Attractiveness of the telehealth platform.
Tidsramme: 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
At monthly intervals during the study period (6 months for each patient)
Travel cost burden - in-person group
Tidsramme: At monthly intervals during the study period (6 months for each patient)
Survey requesting Patient/caregiver travel distances and durations
At monthly intervals during the study period (6 months for each patient)
Impact of treatment on time - telemedicine group
Tidsramme: 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
At monthly intervals during the study period (6 months for each patient)
Treatment adherence
Tidsramme: At monthly intervals during the study period (6 months for each patient)
Usage data from the SpeechVive and patient attendance at treatment sessions
At monthly intervals during the study period (6 months for each patient)
Change in Vocal intensity level
Tidsramme: Change from baseline after 6 months of treatment
Sound pressure level from speech samples with and without the device in place
Change from baseline after 6 months of treatment
Change in Patient with PD Depression Level
Tidsramme: Change from baseline after 6 months of treatment
Geriatric Depression Scale Short form
Change from baseline after 6 months of treatment
Impact of Life Events for Patient with PD and Caregiver
Tidsramme: Change from baseline after 6 months of treatment
Change in Impact of PD on life satisfaction
Change from baseline after 6 months of treatment
Change in general self-efficacy
Tidsramme: Change from baseline after 6 months of treatment
Self-efficacy for people with disabilities scale
Change from baseline after 6 months of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Speech rate
Tidsramme: Change from baseline after 6 months of treatment
Rate of speech from speech samples with and without the device in place
Change from baseline after 6 months of treatment
Change in Pausing patterns
Tidsramme: Change from baseline after 6 months of treatment
Number and duration of silent and filled pauses from speech samples with and without the device in place
Change from baseline after 6 months of treatment
Change in Caregiver Burden
Tidsramme: Change from baseline after 6 months of treatment
Caregiver Burden Inventory
Change from baseline after 6 months of treatment
Change in Apathy
Tidsramme: Change in baseline after 6 months of treatment for Patient with PD and Caregiver
Apathy Scale
Change in baseline after 6 months of treatment for Patient with PD and Caregiver
Change in Caregiver Ratings Patient's of Communication Competence
Tidsramme: Change in baseline after 6 months of treatment
Communicative Participation Item Bank-Short Form
Change in baseline after 6 months of treatment
Change in Patient with PD Participation in Social Activities
Tidsramme: Change in baseline after 6 months of treatment
Quality of Life in Neurological Disorders (Neuro-QOL)
Change in baseline after 6 months of treatment
Change in Patient with PD Participation in Social Activities
Tidsramme: Change in baseline after 6 months of treatment
Ability to Participate in Social Roles and Activities-Short Form
Change in baseline after 6 months of treatment
Change in Patient with PD Perceived Autonomy
Tidsramme: Change in baseline after 6 months of treatment
7-item Autonomy Subscale of the Basic Psychological Needs Scale
Change in baseline after 6 months of treatment
Patient with PD 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)
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)
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
At the end of the study period (after 6 months)
Caregiver 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
At the end of the study period (after 6 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

SpeechVive, Inc

Samarbejdspartnere

Purdue University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. januar 2018

Primær færdiggørelse (Faktiske)

15. juni 2019

Studieafslutning (Faktiske)

15. juni 2019

Datoer for studieregistrering

Først indsendt

6. april 2016

Først indsendt, der opfyldte QC-kriterier

19. april 2016

Først opslået (Skøn)

20. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1R44DC014867-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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:

  1. Name and institution of PI
  2. Proof of institutional appointment
  3. Names and roles for all individuals who will access the data for the planned analysis
  4. Detailed plan for the use of the data
  5. 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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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