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Development of Software to Provide the SpeechVive Device Via the Internet

18 de septiembre de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

143

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Indiana
      • Lafayette, Indiana, Estados Unidos, 47905
        • SpeechVive, Inc
      • West Lafayette, Indiana, Estados Unidos, 47907
        • Purdue University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

30 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
Conductual: Telemedicine interaction
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
Comparador activo: 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.
Conductual: In person interaction
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Caregiver Quality of Life
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Change from baseline after 6 months of treatment
Self-efficacy for people with disabilities scale
Change from baseline after 6 months of treatment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Speech rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Change from baseline after 6 months of treatment
Caregiver Burden Inventory
Change from baseline after 6 months of treatment
Change in Apathy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

SpeechVive, Inc

Colaboradores

Purdue University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de enero de 2018

Finalización primaria (Actual)

15 de junio de 2019

Finalización del estudio (Actual)

15 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

6 de abril de 2016

Primero enviado que cumplió con los criterios de control de calidad

19 de abril de 2016

Publicado por primera vez (Estimar)

20 de abril de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de septiembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

18 de septiembre de 2019

Última verificación

1 de septiembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1R44DC014867-01A1 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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