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Development of Software to Provide the SpeechVive Device Via the Internet

18 settembre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

143

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Indiana
      • Lafayette, Indiana, Stati Uniti, 47905
        • SpeechVive, Inc
      • West Lafayette, Indiana, Stati Uniti, 47907
        • Purdue University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

30 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Comportamentale: Telemedicine interaction
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
Comparatore attivo: 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.
Dispositivo: 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.
Comportamentale: In person interaction
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Caregiver Quality of Life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Change from baseline after 6 months of treatment
Self-efficacy for people with disabilities scale
Change from baseline after 6 months of treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Speech rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Change from baseline after 6 months of treatment
Caregiver Burden Inventory
Change from baseline after 6 months of treatment
Change in Apathy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

SpeechVive, Inc

Collaboratori

Purdue University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 gennaio 2018

Completamento primario (Effettivo)

15 giugno 2019

Completamento dello studio (Effettivo)

15 giugno 2019

Date di iscrizione allo studio

Primo inviato

6 aprile 2016

Primo inviato che soddisfa i criteri di controllo qualità

19 aprile 2016

Primo Inserito (Stima)

20 aprile 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 settembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 settembre 2019

Ultimo verificato

1 settembre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1R44DC014867-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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