Delivering Group Support for People With Aphasia Through Eva Park
Primary Purpose
Aphasia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Social support groups delivered in EVA Park
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring social support
Eligibility Criteria
Inclusion Criteria:
- Stroke survivor with aphasia; Score within the aphasic range on the Frenchay Aphasia Screening Test (FAST); Fluent pre-stroke user of English.
Exclusion Criteria:
- Co-morbidity affecting cognition; Severe hearing or visual impairments
Sites / Locations
- City, University of London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate
Wait list control
Arm Description
Participants allocated to the immediate arm will receive 6 months of Social support groups delivered in EVA Park immediately after randomisation. They will be re-assessed in Month 7, then receive 6 months of usual care, followed by reassessment in month 14.
Participants allocated to the wait list control arm will receive 6 months of usual care after randomisation. They will be re-assessed in month 7, and will then receive 6 months of social support groups delivered in EVA Park, with reassessment in month 14.
Outcomes
Primary Outcome Measures
Pre to post intervention change on the Warwick Edinburgh Mental Well-being Scale (WEMWBS)
A 14 item questionnaire about feelings of wellbeing
Pre to post intervention change on the Communication Activities of Daily Living test (CADL-2)
A 50 item standardized test of everyday communication activities, designed for people with aphasia
Secondary Outcome Measures
Pre to post intervention change on the Social Connectedness Scale - Revised (Lee et al. 2001)
A 20 item questionnaire about feelings of social connectedness
Pre to post intervention change on The Western Aphasia Battery - Revised (Kertesz, 2007)
A standardized assessment of language impairment designed for people with aphasia
Pre to post intervention change on the Stroke and Aphasia Quality of Life measure (SAQOL-39) (Hilari et al, 2003)
A self reporting questionnaire about health related quality of life designed for people with stroke and aphasia
Full Information
NCT ID
NCT03115268
First Posted
March 24, 2017
Last Updated
August 5, 2019
Sponsor
City, University of London
Collaborators
The Stroke Association, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT03115268
Brief Title
Delivering Group Support for People With Aphasia Through Eva Park
Official Title
Delivering Group Support for People With Aphasia Through Eva Park
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
April 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City, University of London
Collaborators
The Stroke Association, United Kingdom
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
The project will investigate the feasibility and acceptability of a remote support group intervention for people with aphasia, and will investigate the impact of that intervention on measures of wellbeing, quality of life and communication. The intervention will be delivered to 32 participants in Eva Park, a virtual island specifically designed for people with aphasia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
social support
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate
Arm Type
Experimental
Arm Description
Participants allocated to the immediate arm will receive 6 months of Social support groups delivered in EVA Park immediately after randomisation. They will be re-assessed in Month 7, then receive 6 months of usual care, followed by reassessment in month 14.
Arm Title
Wait list control
Arm Type
Active Comparator
Arm Description
Participants allocated to the wait list control arm will receive 6 months of usual care after randomisation. They will be re-assessed in month 7, and will then receive 6 months of social support groups delivered in EVA Park, with reassessment in month 14.
Intervention Type
Behavioral
Intervention Name(s)
Social support groups delivered in EVA Park
Intervention Description
Intervention will comprise support group meetings delivered in EVA Park, a virtual island created for people with aphasia. Scheduled meetings will be held every two weeks, led by the group co-ordinator and volunteers. Participants will have unlimited access to EVA Park, so will be able to meet up with other group members between meetings.
Primary Outcome Measure Information:
Title
Pre to post intervention change on the Warwick Edinburgh Mental Well-being Scale (WEMWBS)
Description
A 14 item questionnaire about feelings of wellbeing
Time Frame
At randomisation and at 7 and 14 months post randomisation
Title
Pre to post intervention change on the Communication Activities of Daily Living test (CADL-2)
Description
A 50 item standardized test of everyday communication activities, designed for people with aphasia
Time Frame
At randomisation and at 7 and 14 months post randomisation
Secondary Outcome Measure Information:
Title
Pre to post intervention change on the Social Connectedness Scale - Revised (Lee et al. 2001)
Description
A 20 item questionnaire about feelings of social connectedness
Time Frame
At randomisation and at 7 and 14 months post randomisation
Title
Pre to post intervention change on The Western Aphasia Battery - Revised (Kertesz, 2007)
Description
A standardized assessment of language impairment designed for people with aphasia
Time Frame
At randomisation and at 7 and 14 months post randomisation
Title
Pre to post intervention change on the Stroke and Aphasia Quality of Life measure (SAQOL-39) (Hilari et al, 2003)
Description
A self reporting questionnaire about health related quality of life designed for people with stroke and aphasia
Time Frame
At randomisation and at 7 and 14 months post randomisation
Other Pre-specified Outcome Measures:
Title
Participant recruitment and attrition rates
Description
The number of participants referred to the project and the proportion who consent; the number of individuals lost to follow up
Time Frame
Throughout recruitment, intervention and follow up period, up to 14 months
Title
Participant views about intervention
Description
Responses to in-depth semi-structured interviews conducted with all participants post intervention
Time Frame
Interviews conducted up to 4 weeks post intervention (Month 7 for immediate arm; month 14 for waitlist control arm)
Title
Group coordinators' and volunteers' views about intervention
Description
Responses to in-depth semi-structured interviews conducted with all coordinators and 8 purposefully selected volunteers
Time Frame
At month 7 for the immediate arm; at month 14 for the waitlist control arm
Title
Qualitative findings from Human Computer Interaction Assessments
Description
Structured observations and interviews conducted with 8 randomly selected participants from each arm, aiming to determine the suitability of EVA Park for delivering support group meetings
Time Frame
Conducted in the first and last week of intervention; Months 1 and 6 for the immediate arm; Months 8 and 13 for the waitlist control arm.
Title
Time spent using EVA Park
Description
Automatic log data of each participant's usage of EVA Park
Time Frame
throughout intervention periods; Months 1 - 6 for the immediate arm; Months 8 - 13 for the waitlist control arm
Title
Treatment cost
Description
Logs of all costs associated with the intervention, relating to: Human Resources, Technical costs, Materials, Capital costs and Travel
Time Frame
Throughout intervention periods; Months 1 - 6 for the immediate arm; Months 8 - 13 for the waitlist control arm.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stroke survivor with aphasia; Score within the aphasic range on the Frenchay Aphasia Screening Test (FAST); Fluent pre-stroke user of English.
Exclusion Criteria:
Co-morbidity affecting cognition; Severe hearing or visual impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Marshall, PhD
Organizational Affiliation
City, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
City, University of London
City
London
ZIP/Postal Code
EC1V0HB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32970784
Citation
Marshall J, Devane N, Talbot R, Caute A, Cruice M, Hilari K, MacKenzie G, Maguire K, Patel A, Roper A, Wilson S. A randomised trial of social support group intervention for people with aphasia: A Novel application of virtual reality. PLoS One. 2020 Sep 24;15(9):e0239715. doi: 10.1371/journal.pone.0239715. eCollection 2020.
Results Reference
derived
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Delivering Group Support for People With Aphasia Through Eva Park
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