Delivering Group Support for People With Aphasia Through Eva Park

NCT03115268 | Completed

• 1 other identifier: TSA 2016/05
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia

Keywords

social support

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pre to post intervention change on the Social Connectedness Scale - Revised (Lee et al. 2001)

  At randomisation and at 7 and 14 months post randomisation

• Pre to post intervention change on The Western Aphasia Battery - Revised (Kertesz, 2007)

  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)

  At randomisation and at 7 and 14 months post randomisation

Other Outcomes (6)

• Participant recruitment and attrition rates

  Throughout recruitment, intervention and follow up period, up to 14 months

• Participant views about 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

  At month 7 for the immediate arm; at month 14 for the waitlist control arm

Study Arms (2)

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.

Behavioral: Social support groups delivered in EVA Park

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.

Behavioral: Social support groups delivered in EVA Park

Interventions

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.

Immediate; Wait list control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivor with aphasia; Score within the aphasic range on the Frenchay Aphasia Screening Test (FAST); Fluent pre-stroke user of English.

You may not qualify if:

• Co-morbidity affecting cognition; Severe hearing or visual impairments

Sponsors & Collaborators

• City, University of London: lead
• The Stroke Association, United Kingdom: collaborator

Study Sites (1)

City, University of London

London, EC1V0HB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32970784 DERIVED

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jane Marshall, PhD

  City, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 14, 2017
• Study Start: May 16, 2017
• Primary Completion: November 30, 2018
• Study Completion: April 15, 2019
• Last Updated: August 6, 2019

Record last verified: 2018-07

Locations

GB (1)