Delivering Group Support for People With Aphasia Through Eva Park

Sponsor
City, University of London (Other)
Overall Status
Completed
CT.gov ID
NCT03115268
Collaborator
The Stroke Association, United Kingdom (Other)
32
1
2
23
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Social support groups delivered in EVA Park
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Delivering Group Support for People With Aphasia Through Eva Park
Actual Study Start Date :
May 16, 2017
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Apr 15, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

  1. 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]

    A 20 item questionnaire about feelings of social connectedness

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

  1. Participant recruitment and attrition rates [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 City, University of London London United Kingdom EC1V0HB

Sponsors and Collaborators

  • City, University of London
  • The Stroke Association, United Kingdom

Investigators

  • Principal Investigator: Jane Marshall, PhD, City, University of London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
City, University of London
ClinicalTrials.gov Identifier:
NCT03115268
Other Study ID Numbers:
  • TSA 2016/05
First Posted:
Apr 14, 2017
Last Update Posted:
Aug 6, 2019
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by City, University of London
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2019