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INcorporating VoIce acTivated Communication Aids Into Everyday Communication (INVITE)

Primary Purpose

Dysarthria

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Communication aid support
Sponsored by
University of Sheffield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dysarthria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnsley Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Outcomes

Primary Outcome Measures

Goal Attainment Scale (measuring change between time points of distance from goal)
Measures attainment of participant defined goals.

Secondary Outcome Measures

Pragmatic Profile of Everyday Communication Skills in Adults (measuring change between time points of pragmatic communication)
Assesses pragmatic language use

Full Information

First Posted
April 20, 2023
Last Updated
May 4, 2023
Sponsor
University of Sheffield
Collaborators
Barnsley Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05859438
Brief Title
INcorporating VoIce acTivated Communication Aids Into Everyday Communication
Acronym
INVITE
Official Title
INcorporating VoIce acTivated Communication Aids Into Everyday Communication
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sheffield
Collaborators
Barnsley Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysarthria

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Communication aid support
Intervention Description
Support to use voice input voice output communication aids
Primary Outcome Measure Information:
Title
Goal Attainment Scale (measuring change between time points of distance from goal)
Description
Measures attainment of participant defined goals.
Time Frame
Baseline, 3 and 6 months
Secondary Outcome Measure Information:
Title
Pragmatic Profile of Everyday Communication Skills in Adults (measuring change between time points of pragmatic communication)
Description
Assesses pragmatic language use
Time Frame
Baseline, 3 and 6 months.
Other Pre-specified Outcome Measures:
Title
Speed of Communication by measuring time taken to speak out phrase with device - measuring change between timepoints.
Description
Measuring speed of communicating with communication aid
Time Frame
3 and 6 months
Title
System Usability Scale (measuring change between time points)
Description
Questionnaire asking about usability of communication aid
Time Frame
3 and 6 months
Title
Semi-structured interview
Description
Conversation to ascertain participants experience
Time Frame
Baseline
Title
Semi-structured interview
Description
Conversation to ascertain participants experience
Time Frame
3 months
Title
Semi-structured interview
Description
Conversation to ascertain participants experience
Time Frame
6 months
Title
Participant diary (emails between participant and research which will be used as qualitative data).
Description
Email diary
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Fryer, PhD
Phone
07726597377
Email
k.fryer@sheffield.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Hawley, PhD
Phone
07540 674948
Email
mark.hawley@sheffield.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Fryer
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnsley Hospital NHS Foundation Trust
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Fryer, PhD
Email
k.fryer@sheffield.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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INcorporating VoIce acTivated Communication Aids Into Everyday Communication

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