Clinical trial NCT03755063: Recovernow: Tablet-Based Speech Therapy For Post-Stroke Aphasia
Official title: Recovernow: A Multicentre Phase II Randomized Controlled Trial Of Early Mobile Tablet-Based Speech Therapy For Acute Stroke Patients With Aphasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke Sequelae
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RECOVERNOW is A MULTICENTRE PHASE II RANDOMIZED CONTROLLED TRIAL OF EARLY MOBILE TABLET-BASED SPEECH THERAPY FOR ACUTE STROKE PATIENTS WITH APHASIA. Using a novel futility design, investigators will randomize acute care in-patients with stroke to mobile tablet-based speech therapy applications vs the standard of care. Primary outcome is improvement in the Western Aphasia Battery Aphasia (WAB-R)

Overall Study Aim: The primary study aim is to determine the futility and potential efficacy of mobile tablet-based speech therapy for post stroke aphasia.

Primary Endpoint: The primary outcome measure is change in the Aphasia quotient (AQ) from the WAB-R at 90 days. The WAB-R is a standardized aphasia battery. The AQ is calculated from four language sub-tests measuring spontaneous speech, word comprehension, repetition, and word finding.)

Secondary Endpoints: The results of the cost-effectiveness analysis will be expressed as the incremental cost per one-unit improvement in AQ and the incremental cost per one quality-adjusted life year (QALY) gained.

Population: 226 participants will be enrolled over 3 years. Males and females, \>18 years of age, with diagnosis of acute ischemic/hemorrhagic stroke confirmed by routine head computerized tomography (CT) scan with mild to moderate aphasia.

Phase: II

Number of Sites: It is anticipated that this will be a multi-center study, with the following facilities participating: The Ottawa Hospital, Ottawa, ON, Foothills Medical Centre, Calgary, Alberta and Toronto Western Hospital.

Protocol Therapy: Patients will be randomized 1:1 to receive either tablets with speech therapy apps (intervention group) or standard of care.

Study Duration: It is estimated that recruitment will take place over 3 years in the three participating centers.

Subject Participation Duration: All patients will be assessed clinically at baseline and Day 90 (+/-10).

Detailed description: Post-stroke aphasia is a major cause of disability. Aphasia is a heterogeneous condition and can manifest in a variety of communication impairments, including difficulty producing words or sentences and understanding spoken and/or written language. Compared to stroke patients without aphasia, patients with aphasia have longer hospital stays, more severe disability, greater nursing care dependency, are at a greater risk for depression, are discharged to long-term care more frequently, and are less likely to return to work, even when younger. When compared to non-aphasic patients with similar physical abilities, well-being and social supports, patients with aphasia engage in fewer instrumental activities of daily living (iADL) and report worse quality of life.

Investigators launched the RecoverNow research program in 2014 in an attempt to address the delays to access stroke rehabilitation from acute care centres. Our concept was to use mobile tablets to "bring rehab to the patient", and leverage the significant downtime experienced by stroke survivors in acute care. A pilot feasibility study using iPads to deliver speech therapy in the acute setting was started. In this study, our speech language pathologist (SLP) personalized the iPads by selecting commercially available speech therapy applications that specifically targeted the individual patients' deficits. Patients admitted to our stroke center underwent standard of care SLP assessments, and were then offered an iPad with instructions to work with the selected apps for a minimum of 1-hour a day. 30 patients in 6 months were enrolled, and demonstrated a recruitment rate of 68%, a retention rate of 97%, and an 83% adherence rate to a prescribed 1hour/day therapy regimen. Patients began using the tablet at a mean 6.8 days after stroke onset, for an average of 149.8 minutes/day throughout their inpatient stay. It was determined feasible to deliver speech therapy in the acute care setting using mobile tablets.

Based on these preliminary studies, the research group worked with the Ottawa Hospital Mobile Health Lab (mHealth) to refine the RecoverNow platform and develop a secure customizable Android operating system-based tablet. Briefly, this new platform is designed to be used by patients with post-stroke aphasia, meets all security requirements of health-care institutions, allows remote interaction between patients and SLPs, and allows patients to take the device with them as they transition from acute care to rehabilitation, home, or alternate levels of care.

In summary, it was shown that it is feasible to deliver speech therapy in the acute care setting using mobile tablets. The therapeutic intervention based on our experiences, the existing literature, and patient preferences was refined. The next step is to test the efficacy and cost-effectiveness of tablet-based speech therapy that begins in the acute care setting. It is proposed to begin with a pilot futility design, given the limited funding envelope for a clinical trial.

Using a novel futility design, this investigation will be Phase II clinical trial to test the potential efficacy of mobile tablet-based speech therapy for post stroke aphasia. Secondary objectives include a preliminary cost-effectiveness analysis and a capturing a variety of outcomes relevant to stroke recover to inform future studies and identify new opportunities for tablet-based therapy.

Eligibility criteria: Inclusion Criteria:

* diagnosis of ischemic/hemorrhagic stroke documented with CT and/or MRI and,
* mild to moderate aphasia, and/or -) Scoring ≥ 1 on the Best Language parameters of the National Institute of Health Stroke Score (NIHSS).

Exclusion Criteria:

* Pre-existing speech, language or cognitive disorders (such as dementia, mild cognitive impairment),
* severe debilitating disease(s) that, in the opinion of the investigator, would preclude them from being able to complete the study to follow-up (ex: end-stage malignancy, ALS),
* Severe comprehension deficits (unable to follow simple one-step commands and/or unable to respond to yes/no questions reliably), and
* English is not the primary language
* subarachnoid, subdural and epidural hemorrhages.

Primary outcomes:
measure: Change in Western Aphasia Battery (WAB-R) scores
timeFrame: 3 years
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 3 years
Other outcomes:
measure: Stroke and Aphasia Quality of Life Scale
timeFrame: 3 years
measure: Communicative Effectiveness Index (CETI)
timeFrame: 3 years
measure: Cognitive Linguistic Quick Test-Plus (CLQT+)
timeFrame: 3 years
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: 3 years
measure: National Institutes of Health Stroke Scale
timeFrame: 3 years
measure: Barthel index
timeFrame: 3 years
measure: Modified Rankin Scale
timeFrame: 3 years
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network / University of Toronto
state: Ontario
Study officials:
affiliation: Scientific Investigator, OHRI
name: Dar Dowlatshahi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: