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Development of Software to Provide the SpeechVive Device Via the Internet

18. September 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

143

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Indiana
      • Lafayette, Indiana, Vereinigte Staaten, 47905
        • SpeechVive, Inc
      • West Lafayette, Indiana, Vereinigte Staaten, 47907
        • Purdue University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

30 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: 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.
Verhalten: Telemedicine interaction
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
Aktiver 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.
Gerät: 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.
Verhalten: In person interaction
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Caregiver Quality of Life
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change from baseline after 6 months of treatment
Self-efficacy for people with disabilities scale
Change from baseline after 6 months of treatment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Speech rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change from baseline after 6 months of treatment
Caregiver Burden Inventory
Change from baseline after 6 months of treatment
Change in Apathy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

SpeechVive, Inc

Mitarbeiter

Purdue University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Januar 2018

Primärer Abschluss (Tatsächlich)

15. Juni 2019

Studienabschluss (Tatsächlich)

15. Juni 2019

Studienanmeldedaten

Zuerst eingereicht

6. April 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. April 2016

Zuerst gepostet (Schätzen)

20. April 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. September 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. September 2019

Zuletzt verifiziert

1. September 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1R44DC014867-01A1 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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