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Post-stroke communication deficits (PSCD) are a common symptom of patients having sustained a stroke. These deficits include difficulty to produce or understand language, motor speech disorders and cognitive-communication disorders. It is estimated that approximately 40% of stroke survivors will have communication disorders post stroke.
In this randomized controlled study, the investigators' objective is to test the value of providing a mobile platform-based Speech Language Therapy (SLT) program to patients discharged from an acute care hospital with stroke and PSCD and awaiting outpatient rehab services versus standard of care treatment. The investigators will offer iPad-based SLT/standard of treatment to a convenience sample of 20 patients with post-stroke communication deficits. The primary outcome will be feasibility (recruitment rate, adherence rate, retention rate, and protocol deviations), and the secondary outcome will be improvement in PSCD.
A. APPLICANT INFORMATION
Proposed Project Title TeleRehab for Patients with Post-Stroke Communication Deficits using Mobile Technology
Primary Investigator
Karen Mallet, M.H.Sc., M.Ed. SLP (C) Speech-Language Pathologist Champlain Regional Stroke Network and the Ottawa Hospital - Civic Campus 1053 Carling Avenue, Ottawa, ON K1Y 4E9
Co-PI: Dariush Dowlatshahi MD PhD FRCPC Assistant Professor, University of Ottawa Scientist, Ottawa Hospital Research Institute Ottawa Hospital Civic Campus C2182b 1053 Carling Ave, Ottawa, ON K1Y 4E9
Primary Research Site Ottawa Hospital Research Institute
B. LAY SUMMARY Post-stroke communication deficits (PSCD) are a common symptom of patients having sustained a stroke. These deficits include difficulty to produce or understand language, motor speech disorders and cognitive-communication disorders. It is estimated that approximately 40% of stroke survivors will have communication disorders post stroke.
Provincially, it is known that 39.8% of mildly disabled stroke survivors were discharged home without services and 13.8% were referred to outpatient rehabilitation services in 2012/13. In the Champlain Region, the overall percentage of patients being referred to outpatient rehabilitation services was only 4.1% in 2012/13 (provincial benchmark 12.8%). Meanwhile, 27.9% of patients were admitted to inpatient rehabilitation . A one month audit at the Ottawa Hospital Civic Campus (October 2014) revealed that 3/39 (7.6%) of patients attended outpatient rehabilitation.
The Champlain Region has identified a gap in services with regards to outpatient and/or community rehabilitation services. That is, the only dedicated outpatient stroke services available in the Champlain Region are at Elizabeth Bruyère. There is the possibility of accessing general outpatient speech and language services at the Montfort Hospital, the Queensway Carleton Hospital and Perth Hospital. However, there are no outpatient services for Renfrew County or the Eastern Counties.
Community Care Access Centers (CCAC) are another source of outpatient rehabilitation. However, these services are limited and are not in keeping with Canadian Stroke Best Practice Recommendations, where it is recommended that clients should have a minimum of 45 minutes per day up to 3 hours per day, 3 to 5 days per week based on patient's needs and goals. Between 2011 and 2013, the mean number of rehabilitation visits provided in the Champlain Region for CCAC was between 3.3 and 5.2 visits [this included the following disciplines Physiotherapy (PT), Occupational therapy (OT), Speech Language Pathology (SLP) & Social Work (SW)] .
Other than publically funded/supported services, patients could access the services of SLPs through community services such as the Aphasia Center of Ottawa (fee for service), the University of Ottawa Inter-professional Clinic (Francophones only) and private SLPs (fee for service). Unfortunately, these are either cost prohibitive or language prohibitive.
Patients being discharged home who require SLP services are sometimes placed on a waitlist to access these services. While others, are not able to access outpatient services because of a variety of reasons including: patient lives at too great a distance from the rehabilitation facility (>30 minutes); unable to access reliable transportation to and from outpatient services; or the patient does not have the stamina to participate in the demands/schedule of outpatient therapy and travel to and from outpatient service.
In this randomized controlled study, the investigators' objective is to test the value of providing a mobile platform-based Speech Language Therapy (SLT) program to patients discharged from an acute care hospital with stroke and PSCD and awaiting outpatient rehab services versus standard of care treatment. The investigators will offer iPad-based SLT/standard of treatment to a convenience sample of 20 patients with post-stroke communication deficits. The primary outcome will be feasibility (recruitment rate, adherence rate, retention rate, and protocol deviations), and the secondary outcome will be improvement in PSCD.
C. OBJECTIVES
Research question:
Is it feasible, practical and effective to deliver SLT using mobile technology (iPad) to patients with PSCD being discharged home/primary residence from the acute care setting?
Rationale PSCD affects 15-40% of patients during the recovery phase after stroke. It limits post-stroke rehabilitation, and is associated with increased disability and mortality. While screening can identify those patients at risk of PSCD, targeted treatment is not always available. Although quality of life in patients with PSCD is difficult to measure directly, the disruption in communication with its likely effects on employment status and social networks suggests that its impact can be profound. Patients with PSCD have greater morbidity than stroke patients without PSCD. While most, if not all, patients with post-stroke PSCD have some functional recovery, residual deficits are common.
Objective 1: To test the feasibility and practicality of using mobile technology (iPad) for delivering SLT to patients with PSCD being discharged HOME/PRIMARY RESIDENCE from the acute care setting
Objective 2: To explore the efficacy of using mobile technology in delivering SLT in patients with PSCD being discharged HOME/PRIMARY RESIDENCE from the acute care setting.
D. APPROACH
Study population: Patients being discharged HOME/PRIMARY RESIDENCE from the acute care setting at TOH and only requiring communication therapy. According to a 2013 Ottawa Hospital census, 50 patients per month are admitted to the Neurology inpatient service with a primary diagnosis of stroke. Also, an ongoing TOH research project using a similar design (iTherapist) was able to recruit approximately 3 to 5 patients per month over a 6 month period. For this study the investigators have selected a convenience sample of 20 patients over an 18 month period.
Patient identification and selection: All patients admitted to the Civic Campus' Neurology inpatient service with a diagnosis of stroke AND communication deficit (as assessed by an SLP) that are being discharged home/primary residence awaiting outpatient SLP services will be screened by research personnel for study eligibility. Patients will first be approached by clinical SLP or clinicians within the circle of care and must give permission to speak to research personnel.
Design and Methods:
This is an 18 month randomized controlled trial, recruiting post-stroke patients presenting with communication deficits.
Intervention: The intervention will consist of patients being randomly assigned to either standard of care or receiving an iPad upon being discharged home from the acute care setting. The iPad will be programmed with specific apps chosen from the following list:
The apps chosen will be specific to their communication therapy needs. These apps will be monitored remotely by an SLP. A weekly check-in with the patient will be had with an SLP using one of the following: Skype, Facetime and/or Telephone.
Patients will then be randomized to one of two groups on a 1:1 ratio:
Group I (Treatment Group): The study SLP will cater the specific regimen to individual patients based on the pattern of communication deficits. In keeping with the Canadian Stroke Best Practice Recommendations and Quality Based Procedures Handbook, the study SLP will instruct the patient to use the apps for at least one-hour per day, until they are admitted to outpatient SLP services or for a maximum of 8 weeks, whichever comes first. Throughout the telemedicine treatment phase, patients' progress will be monitored remotely by a study SLP through Apps/Skype/Facetime/Telephone consultation on a weekly basis.
Patients will also be instructed to record the amount of time they spend using the iPad in an electronic form on the device itself.
Group 2 (Control Group):
Patients will be sent home with standard of care.
Data collection All patient data will de-identified. The investigators will retain age at enrollment, sex, co-morbid medical history (vascular and neurologic conditions: MI, CAD, HTN, DM), stroke type and severity (NIHSS and MRS stroke scores). The investigators will also retain baseline and follow-up language testing results, and total usage time of the iPad.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | The study SLP will instruct the patient to use the ipad apps as intervention for at least one-hour per day, until they are admitted to outpatient SLP services or for a maximum of 8 weeks, whichever comes first. Throughout the telemedicine treatment phase, patients' progress will be monitored remotely by a study SLP through Apps/Skype/Facetime/Telephone consultation on a weekly basis. |
|
| Control | No Intervention | Patients will be sent home with standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPad | Behavioral | Using iPad speech therapy apps on patients with post-stroke communication deficits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | The investigators will assess the primary outcome of recruitment by determining: Total number of patients enrolled. This is the numerical total of all patients enrolled in the study | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate | Attending their 8 week follow up | 8 week follow up |
| Adherence Rate | Using iPad for 1 hour per day or paper and pen activities for 1 hour per day |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome (Potential Improvement) | The investigators will measure the secondary outcome of the study by measuring any potential improvements in communication by comparing pre and post-intervention SLP assessments. The latter will be performed by a blinded study SLP. SLPs used standard of care approach to assessing communication. As a result, the heterogeneity of the tests leads to some difficulties with regards to making a statement about improvement. |
Inclusion Criteria:
Patients with diagnosis of stroke being discharged from the Neurology unit and/or the Neurology Acute Care Unit in the Civic Campus of TOH.
Patients presenting with overall mild to moderate communication deficits, And/or
Patients with score ≥ 1 on the best language and/or dysarthria parameters of the National Institute of Health Stroke Score (NIHSS)
Stroke Patients being discharged to their HOME/PRIMARY RESIDENCE awaiting outpatient speech and language therapy services.
And/or
Patients being discharged to their HOME/PRIMARY RESIDENCE who would benefit from SLP therapy services but are unable to receive these secondary to various accessibility challenges (i.e. remote geographical location, limited service availability, transportation, unable to pay for SLP services).
Patients must have access to Wi-Fi connection at their HOME/PRIMARY RESIDENCE.
Exclusion Criteria:
1. Patients with pre-existing speech, language disorders or cognitive disorders (such as dementia).
2. Patients with severe debilitating disease(s) that, in the opinion, of the investigator will not be able to perform the required tasks of the study (ex: end-stage malignancy, ALS).
3. Patients with severe comprehension deficits 4. Patients not having access to Wi-Fi connection at HOME/PRIMARY RESIDENCE. 5. Patients who will be accessing the services of a private SLP while awaiting outpatient rehab.
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| Name | Affiliation | Role |
|---|---|---|
| Karen Mallet, M.H.Sc | Speech language Pathologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1Y4E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15733022 | Background | Berthier ML. Poststroke aphasia : epidemiology, pathophysiology and treatment. Drugs Aging. 2005;22(2):163-82. doi: 10.2165/00002512-200522020-00006. | |
| 15947263 | Background | Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | The study SLP will instruct the patient to use the ipad apps as intervention for at least one-hour per day, until they are admitted to outpatient SLP services or for a maximum of 8 weeks, whichever comes first. Throughout the telemedicine treatment phase, patients' progress will be monitored remotely by a study SLP through Apps/Skype/Facetime/Telephone consultation on a weekly basis. iPad: Using iPad speech therapy apps on patients with post-stroke communication deficits |
| FG001 | Control | Patients will be sent home with standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | The study SLP will instruct the patient to use the ipad apps as intervention for at least one-hour per day, until they are admitted to outpatient SLP services or for a maximum of 8 weeks, whichever comes first. Throughout the telemedicine treatment phase, patients' progress will be monitored remotely by a study SLP through Apps/Skype/Facetime/Telephone consultation on a weekly basis. iPad: Using iPad speech therapy apps on patients with post-stroke communication deficits |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment | The investigators will assess the primary outcome of recruitment by determining: Total number of patients enrolled. This is the numerical total of all patients enrolled in the study | Patients eligible for study | Posted | Count of Participants | Participants | 13 months |
|
|
Through study completion, up to 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Standards of Care | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Mallet | Champlain Regional Stroke Network & Ottawa Hospital Research Institute | 6137985555 | 13414 | kmallet@toh.ca |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2016 | Nov 3, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 8 week follow up |
| Percentage of Patients Being Engaged in Study | Survey addressing recruitment & timing of intervention, iPad and apps, recovery goals and length of therapy | 8 week follow up |
| 8 week follow up |
| BG001 | Control | Patients will be sent home with standard of care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Ischemic | Number | participants |
|
| Hemorrhagic | Number | participants |
|
| Level of Education | Number | participants |
|
| Computer knowledge | Number | participants |
|
|
| Secondary | Retention Rate | Attending their 8 week follow up | 5 lost to follow up | Posted | Count of Participants | Participants | 8 week follow up |
|
|
|
| Secondary | Adherence Rate | Using iPad for 1 hour per day or paper and pen activities for 1 hour per day | 5 participants lost to follow up | Posted | Count of Participants | Participants | 8 week follow up |
|
|
|
| Secondary | Percentage of Patients Being Engaged in Study | Survey addressing recruitment & timing of intervention, iPad and apps, recovery goals and length of therapy | Posted | Number | percentage of participants | 8 week follow up |
|
|
|
| Other Pre-specified | Exploratory Outcome (Potential Improvement) | The investigators will measure the secondary outcome of the study by measuring any potential improvements in communication by comparing pre and post-intervention SLP assessments. The latter will be performed by a blinded study SLP. SLPs used standard of care approach to assessing communication. As a result, the heterogeneity of the tests leads to some difficulties with regards to making a statement about improvement. | Not Posted | 8 week follow up | Participants |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Treatment | Received iPad | 0 | 10 | 0 | 10 | 0 | 10 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |