Delivering Group Support for People With Aphasia Through Eva Park

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.

Study Overview

• Status: Completed
• Conditions: Aphasia
• Intervention / Treatment: Behavioral: Social support groups delivered in EVA Park

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V0HB
    • City, University of London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Immediate; 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; 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.
ACTIVE_COMPARATOR: Wait list control; 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; 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.

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

Other Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: City, University of London
• Collaborators: The Stroke Association, United Kingdom
• Investigators: Principal Investigator: Jane Marshall, PhD, City, University of London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2017
• Primary Completion (ACTUAL): November 30, 2018
• Study Completion (ACTUAL): April 15, 2019

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (ACTUAL): April 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: social support
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: TSA 2016/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No