Stroke Circulatory System
Conditions
Interventions
There are two stages to the ELLA study. Phase one (months 1 to 11) is the preparatory stage, including developing training and resources. Phase two (months 12 to 27) is a feasibility randomised contro
Sponsors
East London NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Participants with aphasia: 1. Aged 18 years old or over 2. Diagnosis of post-stroke aphasia (clinician assessment) 3. Living in the community 4. Capacity to give informed consent Significant others: 1. Nominated by a participant with aphasia 2. Be in contact with the person with aphasia at least once per week 3. Mental capacity to make an informed decision Treating therapists: 1. Aged over 18 years old 2. Able to make a fully informed, considered decision 3. Have full DBS clearance 4. Have successfully completed the ELLA training Speech and Language Therapists: 1. Qualified and registered with HCPC as a Speech and Language Therapist 2. Work at least part of the week with people with aphasia 3. Able to supervise student SLTs and therapy assistants or apprentices 4. Have completed the City St George’s required training for student supervision as appropriate Speech and Language Therapy students: 1. Current student at City St George’s, University of London Therapy assistants, apprentices, or rehabilitation support workers: 1. Currently working with people with aphasia at least part of the week 2. Under the supervision of a qualified SLT
Exclusion criteria
Exclusion criteria: Participants with aphasia: 1. Lack capacity to make an informed decision 2. Have a diagnosis of dementia 3. Have a co-existing degenerative or terminal co-morbidity 4. Have severe uncorrected visual or hearing problems 5. Did not speak English fluently prior to the stroke, according to self or family report 6. Ongoing debilitating psychiatric disorder or complex mental health needs that would interfere with their ability to receive ELLA (e.g., psychosis, but not low mood) 7. Live outside the area of the community services 8. Already participating in a Speech and Language Therapy or mental health research study 9. Unable to tolerate two or more therapy sessions a week Significant others: 1. Lack mental capacity to make an informed decision 2. Have a co-existing degenerative or terminal co-morbidity 3. Have severe uncorrected visual or hearing problems 4. Do not speak fluent English which would compromise their ability to take part in an interview Treating therapists: 1. Do not work with people with aphasia 2. Have not attended or failed the ELLA training 3. Are students with reasonable adjustments which preclude them from delivering the ELLA intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes. Outcomes 1- 4 will be calculated using numbers presented in the CONSORT diagram; progression will be assessed using the traffic light criteria. 1. Proportion eligible/ screened measured using screening logs at the end of the 6 months recruitment period, =30% progress; 20-29% amend; <20% stop 2. Proportion who consent/ screened measured using consent forms at the end of the 6 months recruitment period, =60% progress; 40-59% amend; <40% stop 3. Recruitment over the course of the study measured using monthly consent rate over the 6-month recruitment period, =32 progress; 20-32 amend; <20 stop 4. Retention at 6 months post randomisation measured using follow up numbers of participants completing 6-month assessment (those who have not withdrawn or are lost to follow up), =80% or greater progress; 64-79% amend; <64% stop 5. Proportion who adhere measured using therapy logs to determine if participants have received at least 12 sessions at the end of the treatment period, =60% progress; 49-59% amend; <49% stop | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Communicative participation - measured using the Communicative Participation Item Bank at baseline, 3 and 6 months 2. Psychological distress - measured using the General Health Questionnaire - 12 item version at baseline, 3 months and 6 months 3. Health-related quality of life - measured using the Stroke and Aphasia Quality of Life scale - 39 item version (SAQOL-39g) 4. Language - measured using the Western Aphasia Battery- Revised at baseline and 6 months 5. Quality of life - measured using European Quality of Life measure (5 dimensions, 5 levels) (EQ5D5L) at baseline, 3 months and 6 months | — |
Countries
England, United Kingdom
Contacts
Public ContactSarah Northcott
Outcome results
None listed