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Development of Software to Provide the SpeechVive Device Via the Internet

18. září 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

143

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Indiana
      • Lafayette, Indiana, Spojené státy, 47905
        • SpeechVive, Inc
      • West Lafayette, Indiana, Spojené státy, 47907
        • Purdue University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

30 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: 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.
Behaviorální: Telemedicine interaction
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
Aktivní komparátor: 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.
Přístroj: 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.
Behaviorální: In person interaction
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Caregiver Quality of Life
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Change from baseline after 6 months of treatment
Self-efficacy for people with disabilities scale
Change from baseline after 6 months of treatment

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Speech rate
Časové okno: 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
Časové okno: 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
Časové okno: Change from baseline after 6 months of treatment
Caregiver Burden Inventory
Change from baseline after 6 months of treatment
Change in Apathy
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

SpeechVive, Inc

Spolupracovníci

Purdue University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

26. ledna 2018

Primární dokončení (Aktuální)

15. června 2019

Dokončení studie (Aktuální)

15. června 2019

Termíny zápisu do studia

První předloženo

6. dubna 2016

První předloženo, které splnilo kritéria kontroly kvality

19. dubna 2016

První zveřejněno (Odhad)

20. dubna 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. září 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. září 2019

Naposledy ověřeno

1. září 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1R44DC014867-01A1 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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