Clinical trial NCT03115268: 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
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: social support
Lead sponsor: City, University of London
Sponsor class: OTHER
Collaborators: name: The Stroke Association, United Kingdom
First posted: 2017-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pre to post intervention change on the Warwick Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: At randomisation and at 7 and 14 months post randomisation
measure: Pre to post intervention change on the Communication Activities of Daily Living test (CADL-2)
timeFrame: At randomisation and at 7 and 14 months post randomisation
Secondary outcomes:
measure: Pre to post intervention change on the Social Connectedness Scale - Revised (Lee et al. 2001)
timeFrame: At randomisation and at 7 and 14 months post randomisation
measure: Pre to post intervention change on The Western Aphasia Battery - Revised (Kertesz, 2007)
timeFrame: At randomisation and at 7 and 14 months post randomisation
measure: Pre to post intervention change on the Stroke and Aphasia Quality of Life measure (SAQOL-39) (Hilari et al, 2003)
timeFrame: At randomisation and at 7 and 14 months post randomisation
Other outcomes:
measure: Participant recruitment and attrition rates
timeFrame: Throughout recruitment, intervention and follow up period, up to 14 months
measure: Participant views about intervention
timeFrame: Interviews conducted up to 4 weeks post intervention (Month 7 for immediate arm; month 14 for waitlist control arm)
measure: Group coordinators' and volunteers' views about intervention
timeFrame: At month 7 for the immediate arm; at month 14 for the waitlist control arm
measure: Qualitative findings from Human Computer Interaction Assessments
timeFrame: 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.
measure: Time spent using EVA Park
timeFrame: throughout intervention periods; Months 1 - 6 for the immediate arm; Months 8 - 13 for the waitlist control arm
measure: Treatment cost
timeFrame: Throughout intervention periods; Months 1 - 6 for the immediate arm; Months 8 - 13 for the waitlist control arm.
Locations:
city: London
country: United Kingdom
facility: City, University of London
Study officials:
affiliation: City, University of London
name: Jane Marshall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.