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| Name | Class |
|---|---|
| The Stroke Association, United Kingdom | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate | Experimental | 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. |
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| Wait list control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social support groups delivered in EVA Park | Behavioral | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant recruitment and attrition rates | The number of participants referred to the project and the proportion who consent; the number of individuals lost to follow up | Throughout recruitment, intervention and follow up period, up to 14 months |
| Participant views about intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Marshall, PhD | City, University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City, University of London | London | EC1V0HB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32970784 | Derived | 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. |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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|
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 |
Responses to in-depth semi-structured interviews conducted with all participants post intervention |
| Interviews conducted up to 4 weeks post intervention (Month 7 for immediate arm; month 14 for waitlist control arm) |
| Group coordinators' and volunteers' views about intervention | Responses to in-depth semi-structured interviews conducted with all coordinators and 8 purposefully selected volunteers | At month 7 for the immediate arm; at month 14 for the waitlist control arm |
| Qualitative findings from Human Computer Interaction Assessments | 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 | 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. |
| Time spent using EVA Park | Automatic log data of each participant's usage of EVA Park | throughout intervention periods; Months 1 - 6 for the immediate arm; Months 8 - 13 for the waitlist control arm |
| Treatment cost | Logs of all costs associated with the intervention, relating to: Human Resources, Technical costs, Materials, Capital costs and Travel | Throughout intervention periods; Months 1 - 6 for the immediate arm; Months 8 - 13 for the waitlist control arm. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |