Delivering Group Support for People With Aphasia Through Eva Park

Study Overview
=================
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.

Official Title
-----------------
Delivering Group Support for People With Aphasia Through Eva Park

Conditions
-----------------
Aphasia

Intervention / Treatment
-----------------
* Behavioral: Social support groups delivered in EVA Park


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate<br>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. | Behavioral: Social support groups delivered in EVA Park<br>* 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.<br>|
| Active Comparator: Wait list control<br>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. | Behavioral: Social support groups delivered in EVA Park<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre to post intervention change on the Warwick Edinburgh Mental Well-being Scale (WEMWBS) | A 14 item questionnaire about feelings of wellbeing | At randomisation and at 7 and 14 months post randomisation | 
| 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 | At randomisation and at 7 and 14 months post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre to post intervention change on the Social Connectedness Scale - Revised (Lee et al. 2001) | A 20 item questionnaire about feelings of social connectedness | At randomisation and at 7 and 14 months post randomisation | 
| Pre to post intervention change on The Western Aphasia Battery - Revised (Kertesz, 2007) | A standardized assessment of language impairment designed for people with aphasia | At randomisation and at 7 and 14 months post randomisation | 
| 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 | At randomisation and at 7 and 14 months post randomisation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
social support