- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05859438
INcorporating VoIce AcTivated Communication Aids Into Everyday Communication (INVITE)
Dysarthria is a speech disorder resulting in speech that is slow, slurred and difficult to understand, limiting a person's opportunities to study, work, and develop relationships.
People with dysarthria often use communication aids to help them to communicate creating spoken messages using a keyboard, touchscreen or joystick. Communication aids can increase independence but are often too slow to keep pace with normal conversation.
Developments in speech recognition technology have led to apps which can learn to recognise a set of words or sounds spoken by the individual with dysarthria, and connect these with a clear spoken output. The investigator's previous research provides some evidence that these voice input communication apps may be faster than traditional communication aids. This study aims to find out who can benefit from this technology, and what support they will need to use it successfully. This information can be used by professionals involved in providing communication aids, and will help the investigators to plan further research into their effectiveness.
This research has two phases:
- 20-30 individuals with dysarthria will be asked to use a voice input communication app for 6 months. The investigator's will collect information on whether VocaTempo improves their communication, and helps participants to reach their goals.
- Focus groups will be held with professionals involved in providing and supporting people with communication aids, to understand factors affecting their ability to provide the support identified as needed in part 1 of the research.
The investigators have a panel of communication aid users, who are advising and contributing throughout the study, for example, helping the investigators to identify informal support networks to recruit participants from. The investigators will let people know about the findings through support groups used by people with dysarthria, publications read by people involved in providing communication aids, and academic papers and conferences.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barnsley, United Kingdom, S75 2EP
- Barnsley Hospital NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 years of age
- Moderately or severely dysarthric (identified using the Frenchay Dysarthria assessment
- Minimum of 2 distinct vocalisations over which they have voluntary control
- Able to give informed consent and take part in interviews with appropriate communication support (scores level 1-3 on consent support tool)
- Communicates predominantly in English
Exclusion Criteria:
- They have significant cognitive impairment and are unable to give informed consent on their own behalf or actively take part in interviews (tested using the Consent Support Tool, scoring at level 4), or are unable to use a communication aid.
- They have no controlled vocalisations.
- They have dysarthria as a result of a progressive condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
Support to use voice input voice output communication aids
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goal Attainment Scale (measuring change between time points of distance from goal)
Time Frame: Baseline, 3 and 6 months
|
Measures attainment of participant defined goals.
|
Baseline, 3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pragmatic Profile of Everyday Communication Skills in Adults (measuring change between time points of pragmatic communication)
Time Frame: Baseline, 3 and 6 months.
|
Assesses pragmatic language use
|
Baseline, 3 and 6 months.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speed of Communication by measuring time taken to speak out phrase with device - measuring change between timepoints.
Time Frame: 3 and 6 months
|
Measuring speed of communicating with communication aid
|
3 and 6 months
|
|
System Usability Scale (measuring change between time points)
Time Frame: 3 and 6 months
|
Questionnaire asking about usability of communication aid
|
3 and 6 months
|
|
Semi-structured interview
Time Frame: Baseline
|
Conversation to ascertain participants experience
|
Baseline
|
|
Semi-structured interview
Time Frame: 3 months
|
Conversation to ascertain participants experience
|
3 months
|
|
Semi-structured interview
Time Frame: 6 months
|
Conversation to ascertain participants experience
|
6 months
|
|
Participant diary (emails between participant and research which will be used as qualitative data).
Time Frame: 6 months
|
Email diary
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kate Fryer, University of Sheffield
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 171440
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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