Delivering Group Support for People With Aphasia Through Eva Park

Aphasia Clinical Trial

Official title:

Delivering Group Support for People With Aphasia Through Eva Park

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115268
• Other study ID #: TSA 2016/05
• Status: Completed
• Phase: N/A
• Start date: May 16, 2017
• Est. completion date: April 15, 2019

Study information

• Verified date: July 2018
• Source: City, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 15, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia

Intervention

Behavioral:
• Social support groups delivered in EVA Park
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.

Locations

Country	Name	City	State
United Kingdom	City, University of London	London

Sponsors (2)

Lead Sponsor	Collaborator
City, University of London	The Stroke Association, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Participant views about intervention	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)
Other	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
Other	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.
Other	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
Other	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.
Primary	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
Primary	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	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
Secondary	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
Secondary	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