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OpenTrials
Completed

NCT Number: NCT03115268

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City, University of London

London, EC1V0HB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pre to post intervention change on the Warwick Edinburgh Mental Well-being Scale (WEMWBS)

    Time frame: At randomisation and at 7 and 14 months post randomisation

    A 14 item questionnaire about feelings of wellbeing

  2. Pre to post intervention change on the Communication Activities of Daily Living test (CADL-2)

    Time frame: At randomisation and at 7 and 14 months post randomisation

    A 50 item standardized test of everyday communication activities, designed for people with aphasia

Secondary outcomes

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

    Time frame: At randomisation and at 7 and 14 months post randomisation

    A 20 item questionnaire about feelings of social connectedness

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

    Time frame: At randomisation and at 7 and 14 months post randomisation

    A standardized assessment of language impairment designed for people with aphasia

  3. Pre to post intervention change on the Stroke and Aphasia Quality of Life measure (SAQOL-39) (Hilari et al, 2003)

    Time frame: At randomisation and at 7 and 14 months post randomisation

    A self reporting questionnaire about health related quality of life designed for people with stroke and aphasia

Other outcomes

  1. Participant recruitment and attrition rates

    Time frame: Throughout recruitment, intervention and follow up period, up to 14 months

    The number of participants referred to the project and the proportion who consent; the number of individuals lost to follow up

  2. Participant views about intervention

    Time frame: Interviews conducted up to 4 weeks post intervention (Month 7 for immediate arm; month 14 for waitlist control arm)

    Responses to in-depth semi-structured interviews conducted with all participants post intervention

  3. Group coordinators' and volunteers' views about intervention

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

    Responses to in-depth semi-structured interviews conducted with all coordinators and 8 purposefully selected volunteers

  4. Qualitative findings from Human Computer Interaction Assessments

    Time frame: 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.

    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

  5. Time spent using EVA Park

    Time frame: throughout intervention periods; Months 1 - 6 for the immediate arm; Months 8 - 13 for the waitlist control arm

    Automatic log data of each participant's usage of EVA Park

  6. Treatment cost

    Time frame: Throughout intervention periods; Months 1 - 6 for the immediate arm; Months 8 - 13 for the waitlist control arm.

    Logs of all costs associated with the intervention, relating to: Human Resources, Technical costs, Materials, Capital costs and Travel

Sponsors and collaborators

Lead sponsor

City, University of London

Other

Collaborators

  • The Stroke Association, United Kingdom

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 14, 2017
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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