Methods
TIA, stroke, post-stroke, Stroke
TRANSIENT ISCHAEMIC ATTACK, STROKE, STROKE, RECRUITMENT, SECONDARY, REGRESSION, EVENTS, TIA
This was a pragmatic, feasibility Phase II multi-centre stratified randomised
controlled trial with nested process evaluation, designed with collaborative level
patient involvement. The study was approved by the Yorkshire and the Humber NHS
Research Ethics Committee (18/YH/048) and entered on the ISRCTN registry, We monitored trial quality and conduct with a Trial Management Group and an external
Trial Steering Committee. ABa, a stroke survivor, worked with the research team in
designing the study and was a co-applicant on the grant. ABa identified and chaired
a dedicated Patient Carer and Public Involvement advisory group of six stroke
survivors, which met ten times during the study. The advisory group provided input
on all research activities, from documentation through to dissemination. ABa also
represented the group on the trial management group. Two stroke survivors,
independent of the advisory group, were members of the trial steering committee.Participants were recruited between March 2019 and January 2020 with phased site
opening. Data collection ended in April 2020. Follow-up assessments took place 3 and
12 weeks after the start of intervention. Reporting follows the CONSORT 2010
statement: extension to randomised pilot and feasibility trials (see We recruited participants from NHS in-patient stroke services (provided across 10
acute hospitals and linked rehabilitation facilities) in England. Patients were
eligible if they were over 18 years old; had a confirmed stroke (ischaemic or
haemorrhagic); positive for spatial inattention at routine screening; had spatial
inattention impacting on functional performance; at least one week post-stroke;
eligible for standard occupational therapy (for at least one session); able to
provide informed consent (or personal/professional consultee available); able to sit
with support and perform brief research intervention (e.g. sufficient vision,
physical mobility and cognition to be able to participate).Initially we only included in-patients who were one to four weeks post-stroke but in
August 2019 obtained approval for an amendment to widen eligibility beyond four
weeks post-stroke. Staff taking consent followed the Mental Capacity Act
(2005)NHS occupational therapists identified in-patients with spatial inattention as part
of routine clinical care, screening patients for inattention on admission as per
each local site practice. NHS research support staff then screened patients for full
trial eligibility and gained consent. We used accessible information sheets and
consent forms designed with our patient advisory group, alongside consultee
declarations for participants deemed unable to give informed consent. NHS research
support staff collected standard demographic and clinical data following recruitment
including National Institutes of Health Scale (NIHSS). Occupational therapists
completed baseline assessments as soon as possible after consent. Occupational
therapists also provided a subjective assessment of the severity of patient's
inattention on a 4-point scale (none, mild, moderate, severe) using a combination of
functional observations and their clinical judgement. Participants no longer
displaying inattention at the baseline assessments were withdrawn prior to
randomisation.Patient participant demographics and baseline clinical data by study arm.NIHSS: National Institutes of Health Stroke Scale; mRS: modified Rankin
score; TIA: transient ischaemic attack; KF-NAP: Kessler Foundation
Neglect Assessment Process.We allocated treatment using a 3:1 ratio stratified by site (3 intervention: 1
control), using an independent, web-based, third-party (For participants in the intervention arm, prism adaptation training was offered once
a day at the start of routine occupational therapy sessions, for up to three weeks,
five days a week. The training lasted no more than 5 min plus set up time (seating
the participants and fitting the glasses). Participants sat at a table in front of a
semi-circular board raised approximately 18–26 cm off the table. Participants wore
25 dioptre (12.5°) wedge prism glasses adjusted for left or right sided inattention
as appropriate. Occupational therapists or therapy assistants presented a target at
the opposite end of the board and asked the participant to reach under the board to
touch the target, concealing all but the terminal part of the patient's arm. The
therapist presented the target in an unpredictable order and participants pointed to
the target for a maximum of 90 movements, or if movements were slow for ≤5 min. The
prisms were removed after the pointing task. Details of the prism adaptation session
were recorded, including location, delivering staff member, number of movements and
length of session.We trained in-patient occupational therapists and therapy assistants in intervention
delivery. We also trained community staff to provide the intervention on discharge
if required. A member of the research team was present for the first prism
adaptation training session for each participant. See Template for Intervention
Description and Replication (TIDieR) checklist (Following prism removal, participants then received standard occupational therapy. In
consultation with therapists, we specified that therapy following prism adaptation
should be patient-facing activities in which inattention would affect participation.
These were either activities focused on reducing inattention or, for example,
functional activities of daily living training in which inattention would affect
performance. Non-patient facing therapy activities (e.g. family meetings) were not
performed following prism adaptation and staff were asked not to perform prism
adaptation prior to standardised or functional assessments where the intervention
could impact performance. The treating occupational therapist recorded the
frequency, amount and content of each occupational therapy session the participant
received during the three-week period using a study-specific data collection
form.The control group received standard occupational therapy (with no prism adaptation
training), using the same type of patient-facing activities as the intervention
group. Therapy staff recorded the sessions in the same way as the intervention group
for the three-week period. In both groups therapy was personalised in line with the
National Clinical Guidelines for Stroke,We collected data on candidate outcome measures at three time points. Occupational
therapists completed the baseline assessment; NHS research support staff or the
study research team collected 3- and 12-week outcomes, either in hospital or at the
participant's residence if transferred from in-patient care. The COVID-19 lockdown
prevented face-to-face collection of the last few outcome measures however it was
possible to collect some by phone. We trained all staff required on baseline and
outcome assessment delivery. Outcomes were collected by staff unaware of the patient
group where possible.We collected the following assessments from patient participants at all three
timepoints, baseline and 3 and 12 weeks from the start of the intervention: Hearts cancellation test: a subtest of the Oxford Cognitive
Screen.Star cancellation: a subtest of the Behavioural Inattention
Test.Reading test: based on the Radner Reading Test.Kessler Foundation Neglect Assessment Process (KF-NAP)At 12 weeks only we also collected the: Nottingham Extended Activities of Daily Living scale (NEADL),Patient Reported Evaluation of Cognitive State (PRECiS),EQ5D5LModified Rankin score (mRS),Adverse events up to 12 weeksWe collected the following outcome data from carer participants at 12 weeks only:
Carer experience scaleModified carer strain indexSelf-reported informal carer health service useWe collected data to support the process evaluation through brief structured verbal
questions with all patient participants receiving prism adaptation training at 3
weeks post-intervention; and a purposive sample of face-to-face qualitative
interviews with seven patient and five carer participants at 12 weeks; and telephone
interviews with a purposive sample of 10 occupational therapists following delivery
of at least one prism adaptation training session.Responses to structured questions were coded by PM and JW to identify key phrases and
frequency of these across the data. We uploaded transcribed qualitative interview
data to NVivo (version 13). Through repeated reading of the transcripts ED and JT
familiarised themselves with the data to identify initial codes. Following initial
coding, a discussion and comparison was undertaken whereby a consensus was reached,
and six themes identified using thematic analysis.As a Phase II feasibility trial, we did not have a predetermined sample size.
Instead, we predicted a recruitment total of 60–80, based on 1–2 participants per
month from each site for 12 months (allowing for phased site opening). We reported
percentages to assess recruitment, fidelity and attrition. We calculated mean
difference and 95% confidence interval for our primary and secondary outcomes on an
intention-to-treat basis. We sought outcome data for all participants regardless of
treatment adherence unless consent to follow-up was explicitly withdrawn. As there
were small numbers of participants, we could not adjust analyses for site
(stratification criteria) and baseline severity as planned. Therefore, we used
unadjusted regression to obtain the mean difference and 95% CI of the difference for
each outcome assessment at T2. We used Stata 14 statistical software.