Clinical trial NCT05847023: Proof-of-concept Study of LUNA Intervention in Aphasia
Official title: Linguistic Underpinnings of Narrative in Aphasia (LUNA): A Proof-of-concept Study of a Novel Discourse Treatment for Aphasia Using Personal Narratives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aphasia
Stroke
Keywords: Treatment
Feasibility study
Discourse
Lead sponsor: City, University of London
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a single-blind, waitlist, randomised controlled trial of LUNA for people with chronic post-stroke aphasia. Participants will complete assessments at three time points: T1 (weeks 1\&2), T2 (weeks 13 \& 14) and T3 (weeks 25 \& 26). Following T1, participants will be randomised to an immediate or delayed condition. Those in the immediate condition will receive LUNA therapy between T1 and T2. Those in the delayed condition will receive LUNA therapy between T2 and T3. All participants will be invited to participate in in-depth individual semi-structured interviews post-therapy to explore their experiences of taking part in the study.
Primary purpose: TREATMENT

Brief summary: Existing evidence-based treatments for word-level and sentence-level impairments following aphasia typically do not generalise to gains in everyday communication for people with aphasia (after stroke). Novel treatments need to be developed to address this. LUNA is a novel multi-level discourse treatment for people with mild to moderate aphasia that addresses personal narratives in a personalised and meta-linguistic and metacognitive manner. This is a feasibility randomised waitlist controlled trial of LUNA, in 28 people with post-stroke chronic aphasia. It will test feasibility, acceptability, preliminary efficacy, and treatment fidelity. Findings will enable the investigators to judge whether there is merit in proceeding to a larger definitive trial.

Detailed description: One third of stroke survivors have aphasia (a language impairment) which negatively affects communication, relationships, work, socialising, and wellbeing. Speech and language therapy is effective at improving language outcomes for people with aphasia (PWA) but gains in saying words and sentences rarely translate into gains in everyday talking (discourse). Most evidence generated over the last 40 years does not consider how words, sentences and everyday talk are linked together. Recent research signals new approaches are needed targeting multiple levels of language within the same treatment, and treatment needs to explicitly target everyday talking. Research conducted with stakeholders confirms new discourse treatments are a priority to clinicians and researchers, and improved everyday talking is prioritised by PWA as an outcome from rehabilitation.

The proposed research addresses the gap in the evidence base for a theoretically-underpinned multilevel discourse treatment for PWA. The project is titled LUNA and stands for Linguistic Underpinnings of Narrative in Aphasia. It focusses on personal narratives, that is, the short stories people tell others e.g. about recent holiday, funniest memory from school/ work, memorable life moments, etc. Personal stories are central to everyday talking; are important in health, recovery and adjustment; and are commonly used in clinical practice i.e. 70% of speech and language therapists (SLTs) the investigators surveyed in the United Kingdom ask patients to tell personal stories during rehabilitation. LUNA draws on existing word and sentence level treatments that are known to be effective in improving language. The discourse literature is less developed, but describes strategies that similarly feature in LUNA treatment (e.g. telling the key elements of a story and doing so in the correct order so the listener understands). LUNA integrates these and works directly with the participant to improve their own stories. Choosing personalised vocabulary (i.e. the person's own words) increases motivation. Finally, LUNA teaches the person about their language, so they understand their difficulties, thereby empowering them to make connections from clinic to their real life use of talking.

In response to the COVID 19 crisis the investigators plan to conduct all data collection remotely, via video conferencing technology. There is growing evidence that telehealth can be employed successfully in aphasia rehabilitation. Remote administration of aphasia assessment has been shown to be valid, reliable and acceptable to people with aphasia. While not extensively tested, remote therapy has also proved feasible and has produced outcomes that are similar to those achieved by face to face delivery. This study aims to add to the evidence for aphasia tele-rehabilitation by testing the first application of remote discourse therapy.

Aims:

This study will test feasibility of LUNA in terms of participant recruitment and retention, and adherence throughout the study (assessment and treatment sessions). It will explore participant acceptability of LUNA and project procedures (satisfaction, perceived benefits, assessment and treatment burden) in semi-structured individual interviews with participants.

It will investigate initial efficacy by comparing outcomes on a range of measures across participants who have and have not received LUNA intervention. It will assess treatment fidelity by reviewing a sample of videotaped sessions to check they were delivered as intended by the treatment manual. The study will also test the feasibility and acceptability of remote assessment and treatment delivery. For example, recruitment, retention and compliance data will attempt to identify losses due to technological factors; and interview questions will explicitly probe the experience of using video-conferencing technology.

Indicative outcome data will be for remote (not face-to-face) LUNA.

Design:

The study is a single-blind, waitlist, randomised controlled trial of LUNA for people with chronic post-stroke aphasia. Participants will complete assessments at three time points: T1 (weeks 1\&2), T2 (weeks 13 \& 14) and T3 (weeks 25 \& 26). Following T1, participants will be randomised to an immediate or delayed condition. Those in the immediate condition will receive LUNA therapy between T1 and T2. Those in the delayed condition will receive LUNA therapy between T2 and T3. All participants will be invited to participate in in-depth individual semi-structured interviews post-therapy to explore their experiences of taking part in the study.

In line with selection criteria, participants will not be receiving any other speech and language therapy during the study. Owing to COVID 19, it is anticipated that most participants will not have access to usual care (attendance at stroke groups). Some may access on-line supports, for example provided by Aphasia Re-Connect. Use of such services is not an exclusion criterion. Use of other services will be explored in the interviews.

Eligibility criteria: Inclusion Criteria:

* diagnosis of ischaemic or haemorrhagic stroke
* have aphasia due to a stroke that occurred at least 12 months prior to recruitment
* literate and fluent users of English prior to their stroke (self-reported)
* have adequate hearing and vision with aids and glasses, e.g. in order to see pictorial and written assessment and therapy materials
* must have access to a computer or tablet and an internet connection
* must be able to download and access Zoom, either independently or with the support of a friend/family member who is living with them

Exclusion Criteria:

* must not be receiving speech and language therapy elsewhere for the duration of the study. Usual stroke supports, for example provided by the voluntary sector, can proceed, although these are likely to be curtailed owing to COVID-19
* must not be participating in any other aphasia treatment research project for the duration of the study
* must not have severe aphasia, defined as a score of 7 or less on the Frenchay Aphasia Screening Test (FAST: Enderby et al., 1986; unlikely to benefit from treatment)
* must not have a secondary cognitive diagnosis such as dementia. This will be established via self-report and the confirmation of the group co-ordinator

Primary outcomes:
measure: Personal narratives measure (LUNA Discourse Protocol)
timeFrame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
Secondary outcomes:
measure: The Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
timeFrame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
measure: The Communicative Participation Item Bank (CPIB) - General Short Form [Patient Reported Outcome Measure]
timeFrame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
measure: The Communication Confidence Rating Scale for Aphasia (CCRSA) [Patient Reported Outcome Measure]
timeFrame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
measure: The Assessment for Living with Aphasia (ALA) [Patient Reported Outcome Measure]
timeFrame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
measure: Visual Analogue Mood Scales (VAMS) [Patient Reported Outcome Measure]
timeFrame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
Other outcomes:
measure: Percentage of those eligible who consent
timeFrame: Week 27
measure: Percentage of retention
timeFrame: Week 27
measure: Percentage of treatment sessions attended with reasons for non-attendance
timeFrame: Week 27
measure: Rates of missing data
timeFrame: Week 27
measure: Presence of floor or ceiling effects
timeFrame: Week 27
measure: Estimating sample size
timeFrame: Week 27
measure: Assessing treatment fidelity
timeFrame: Week 27
measure: In-depth qualitative interviews
timeFrame: Weeks 25 and 26
measure: The Session Rating Scale
timeFrame: Weeks 25 and 26
Locations:
city: London
country: United Kingdom
facility: Department of Language and Communication Science, City, University of London
Study officials:
affiliation: City, University of London
name: Prof Cruice
role: PRINCIPAL_INVESTIGATOR
affiliation: City, University of London
name: Prof Dipper
role: PRINCIPAL_INVESTIGATOR
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