Development of Software to Provide the SpeechVive Device Via the Internet
18 septembre 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
143
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Indiana
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Lafayette, Indiana, États-Unis, 47905
- SpeechVive, Inc
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West Lafayette, Indiana, États-Unis, 47907
- Purdue University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
30 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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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.
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
|
|
Comparateur actif: 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.
|
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.
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Caregiver Quality of Life
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: At monthly intervals during the study period (6 months for each patient)
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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)
|
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Travel cost burden - in-person group
Délai: At monthly intervals during the study period (6 months for each patient)
|
Survey requesting Patient/caregiver travel distances and durations
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At monthly intervals during the study period (6 months for each patient)
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Impact of treatment on time - telemedicine group
Délai: 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
Délai: 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
Délai: Change from baseline after 6 months of treatment
|
Sound pressure level from speech samples with and without the device in place
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Change from baseline after 6 months of treatment
|
|
Change in Patient with PD Depression Level
Délai: 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
Délai: 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
Délai: Change from baseline after 6 months of treatment
|
Self-efficacy for people with disabilities scale
|
Change from baseline after 6 months of treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Speech rate
Délai: 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
Délai: 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
Délai: Change from baseline after 6 months of treatment
|
Caregiver Burden Inventory
|
Change from baseline after 6 months of treatment
|
|
Change in Apathy
Délai: 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
Délai: Change in baseline after 6 months of treatment
|
Communicative Participation Item Bank-Short Form
|
Change in baseline after 6 months of treatment
|
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Change in Patient with PD Participation in Social Activities
Délai: Change in baseline after 6 months of treatment
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Quality of Life in Neurological Disorders (Neuro-QOL)
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Change in baseline after 6 months of treatment
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Change in Patient with PD Participation in Social Activities
Délai: Change in baseline after 6 months of treatment
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Ability to Participate in Social Roles and Activities-Short Form
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Change in baseline after 6 months of treatment
|
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Change in Patient with PD Perceived Autonomy
Délai: 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
|
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Patient with PD satisfaction - telemedicine group
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Stathopoulos ET, Huber JE, Richardson K, Kamphaus J, DeCicco D, Darling M, Fulcher K, Sussman JE. Increased vocal intensity due to the Lombard effect in speakers with Parkinson's disease: simultaneous laryngeal and respiratory strategies. J Commun Disord. 2014 Mar-Apr;48:1-17. doi: 10.1016/j.jcomdis.2013.12.001. Epub 2013 Dec 28.
- Huber JE, Darling M, Francis EJ, Zhang D. Impact of typical aging and Parkinson's disease on the relationship among breath pausing, syntax, and punctuation. Am J Speech Lang Pathol. 2012 Nov;21(4):368-79. doi: 10.1044/1058-0360(2012/11-0059). Epub 2012 Jul 30.
- Darling M, Huber JE. Changes to articulatory kinematics in response to loudness cues in individuals with Parkinson's disease. J Speech Lang Hear Res. 2011 Oct;54(5):1247-59. doi: 10.1044/1092-4388(2011/10-0024). Epub 2011 Mar 8.
- Huber JE, Darling M. Effect of Parkinson's disease on the production of structured and unstructured speaking tasks: respiratory physiologic and linguistic considerations. J Speech Lang Hear Res. 2011 Feb;54(1):33-46. doi: 10.1044/1092-4388(2010/09-0184). Epub 2010 Sep 15.
- Sadagopan N, Huber JE. Effects of loudness cues on respiration in individuals with Parkinson's disease. Mov Disord. 2007 Apr 15;22(5):651-9. doi: 10.1002/mds.21375.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
26 janvier 2018
Achèvement primaire (Réel)
15 juin 2019
Achèvement de l'étude (Réel)
15 juin 2019
Dates d'inscription aux études
Première soumission
6 avril 2016
Première soumission répondant aux critères de contrôle qualité
19 avril 2016
Première publication (Estimation)
20 avril 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 septembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 septembre 2019
Dernière vérification
1 septembre 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1R44DC014867-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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:
- Name and institution of PI
- Proof of institutional appointment
- Names and roles for all individuals who will access the data for the planned analysis
- Detailed plan for the use of the data
- 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .