NCT02744911

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 26, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

April 6, 2016

Last Update Submit

September 18, 2019

Conditions

Parkinson Disease

Keywords

speech problems

Outcome Measures

Primary Outcomes (12)

  • Change in Caregiver Quality of Life

    Scale of Quality of Life of Care-givers

    Change from baseline after 6 months of treatment

  • Depression: Caregiver Geriatric Depression Scale

    Geriatric Depression Scale

    Change from baseline after 6 months of treatment

  • Change in Patient with PD Ratings of Communication Competence

    Communicative Participation Item Bank-Short Form

    Change from baseline after 6 months of treatment

  • Change in Patient with PD quality of life

    Parkinson's Disease Questionnaire-39

    Change from baseline after 6 months of treatment

  • Attractiveness of the telehealth platform.

    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

    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

    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

    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

    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

    Geriatric Depression Scale Short form

    Change from baseline after 6 months of treatment

  • Impact of Life Events for Patient with PD and Caregiver

    Change in Impact of PD on life satisfaction

    Change from baseline after 6 months of treatment

  • Change in general self-efficacy

    Self-efficacy for people with disabilities scale

    Change from baseline after 6 months of treatment

Secondary Outcomes (12)

  • Change in Speech rate

    Change from baseline after 6 months of treatment

  • Change in Pausing patterns

    Change from baseline after 6 months of treatment

  • Change in Caregiver Burden

    Change from baseline after 6 months of treatment

  • Change in Apathy

    Change in baseline after 6 months of treatment for Patient with PD and Caregiver

  • Change in Caregiver Ratings Patient's of Communication Competence

    Change in baseline after 6 months of treatment

  • +7 more secondary outcomes

Study Arms (2)

Telemedicine group

EXPERIMENTAL

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.

Device: SpeechVive deviceBehavioral: Telemedicine interaction

In person group

ACTIVE COMPARATOR

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.

Device: SpeechVive deviceBehavioral: In person interaction

Interventions

SpeechVive deviceDEVICE

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.

In person groupTelemedicine group
Telemedicine interactionBEHAVIORAL

Participants will interact with the speech-language pathologist using the telemedicine platform from their home.

Telemedicine group
In person interactionBEHAVIORAL

Participants will interact with the speech-language pathologist in-person at the speech pathologist's office

In person group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Neurological diagnoses (except Parkinson's disease)
  • Bilateral hearing aids (since one free ear is required for use of the SpeechVive device)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SpeechVive, Inc

Lafayette, Indiana, 47905, United States

Location

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (5)

  • 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.

    PMID: 24438910BACKGROUND

  • 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.

    PMID: 22846880BACKGROUND

  • 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.

    PMID: 21386044BACKGROUND

  • 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.

    PMID: 20844256BACKGROUND

  • 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.

    PMID: 17266087BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 20, 2016

Study Start

January 26, 2018

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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.

Locations

US(2)