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Trial registered on ANZCTR


Registration number
ACTRN12623001028695
Ethics application status
Approved
Date submitted
23/06/2023
Date registered
22/09/2023
Date last updated
15/09/2024
Date data sharing statement initially provided
22/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
App-based Swallowing Skill Rehabilitation after Stroke
Scientific title
Effectiveness of Intensive, App-based Swallowing Skill-based Rehabilitation vs. Usual Dysphagia Management for Post-stroke Dysphagia in Hospital and Community Settings: A Randomized Controlled Trial
Secondary ID [1] 309466 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 329725 0
dysphagia 330376 0
swallowing impairment 330377 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326626 326626 0 0
Speech therapy
Stroke 327454 327454 0 0
Haemorrhagic
Stroke 327455 327455 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This non-drug, randomized-controlled trial will longitudinally evaluate the effectiveness of intensive, app-based swallowing skill training in post-stroke dysphagia (PSD), across hospital and community settings. Participants will receive up to six months of treatment during the study and across settings (acute hospital [Christchurch Hospital], subacute hospital [Burwood Hospital], home/care facility with outpatient or community rehabilitation).

The experimental group will receive usual dysphagia management (UDM) and additional intensive, app-based swallowing skill training delivered via the Biofeedback in Strength and Skill App (BiSSkApp) technology. This includes a tablet with the downloaded BiSSkApp software, a portable sEMG with compatible charging port, and adhesive patches, all of which will be provided to participants at study enrolment. Participants will receive the trial intervention at the hospital or home/ community settings, where the treatment dosage will be individualized and modified/delivered by Principal Investigators to participants, remotely.

The app-based swallowing skill treatment will require participants to place electrodes under the chin area to detect their submental muscle activity while swallowing. Participants may need to shave their chin to remove any facial hair so that the adhesive patch sticks to the skin. During swallowing, muscle activity will be displayed in the form of a time-by-amplitude waveform on the tablet screen. Participants will be instructed to control the timing and relative force of the muscles while swallowing, so that the peak of the waveform hits a target box that appears on the screen. The app will provide visual and audio feedback regarding the participants task performance. Furthermore, the app will automatically modify the task complexity by increasing or decreasing the target size by 10% following consecutive ‘hits’ or ‘misses’.

Study intervention will be delivered by qualified speech-language therapists with certification in Good Clinical Practice. In addition, both Principal Investigators are experienced in supportive communication, treatment, and rehabilitation of swallowing disorder post-stroke.

The skill-based intervention will be conducted between 10 minutes to one hour per session, twice per day, for five days per week. The treatment dosage will be set between 10 to 100 swallowing trials per session. The researchers will remotely monitor participants’ progress and modify treatment dosage based on the participants’ current level of swallowing functioning.
Treatment dosage will be increased by 1 treatment block if participants adhere to the set dosage across two consecutive sessions in the hospital and a minimum of six sessions per week in the community.

Principal investigators will support participants in the treatment group using BiSSkApp. Principal investigators will monitor and instruct participants remotely through BiSSkApp during rehabilitation sessions, and remotely monitor participants’ progress through a routine review schedule according to settings (e.g., monitor daily when participants stay in the hospital; weekly when participants enter the community).
Intervention code [1] 326338 0
Treatment: Devices
Intervention code [2] 326339 0
Treatment: Other
Intervention code [3] 326340 0
Rehabilitation
Comparator / control treatment
Participants in the control group will receive usual dysphagia management (UDM) as determined by their treating clinicians in the hospital and community settings. They will receive daily dysphagia intervention during hospitalization, and less frequent sessions when they enter the community. The treating clinicians are certified speech-language pathologists, competent in providing usual dysphagia management following the evidence-based practice.

Treating clinicians are blinded to participant study allocation status. The principal investigators will not be involved in planning or providing the UDM provided to the treatment or control group. Thus, the treatment dosage, frequency and management will be directed solely based on treating clinicians’ clinical judgement.
Control group
Active

Outcomes
Primary outcome [1] 335101 0
Yes/No binary outcome regarding participants return to preadmission diet measured by the Functional Oral Intake Scale (FOIS) (Crary et al., 2005)
Timepoint [1] 335101 0
-initial study enrolment (baseline)
-every 5 days during acute hospital and inpatient rehabilitation
-every 10 days in the community immediately after hospital discharge for two months
-thereafter, every 20 days in the community for up to 6 months
Primary outcome [2] 335102 0
Solid ingestion efficiency as measured by ‘ingestion time (seconds)’ via Test of Masticating and Swallowing Solids (ToMaSS) (Huckabee & Lamvik-Gozdzikowska, 2018)
Timepoint [2] 335102 0
-initial study enrolment (baseline)
-acute hospital discharge
-inpatient rehabilitation discharge
-6 months post initial study enrolment.
Primary outcome [3] 335103 0
Fluid ingestion efficiency as measured by ‘swallowing capacity(mL/swallow)’ via Timed Water Swallowing Test (TWST) (Hagglund et al.., 2022).
Timepoint [3] 335103 0
-initial study enrolment(baseline)
-acute hospital discharge
-inpatient rehabilitation discharge
-6 months post initial study enrolment
Secondary outcome [1] 423061 0
Number of swallows produced at rest (Spontaneous Swallowing Frequency [SSF]) (Crary et al.,2013) - Primary Outcome 4
Timepoint [1] 423061 0
-initial study enrolment(baseline)
-acute hospital discharge
-inpatient rehabilitation discharge
-6 months post initial study enrolment
Secondary outcome [2] 423062 0
Presence of aspiration pneumonia as written in medical chart / participants self-report.

The diagnosis of aspiration pneumonia will be determined by medical team following the definition by Mann et al. (1999). Three or more criteria will result in a diagnosis of pneumonia: fever (>38°C), productive cough with purulent sputum, abnormal respiratory examination (tachypnea [>22/min], tachycardia, inspiratory crackles, bronchial breathing), abnormal chest radiograph, arterial hypoxemia (PO2 <70 mm Hg), and isolation of a relevant pathogen (positive gram stain and culture).
Timepoint [2] 423062 0
Assessed at the conclusion of the study.
Secondary outcome [3] 423063 0
Presence of non-oral feeding (Nasogastric Tube/ Percutaneous Endoscopic Gastrostomy Tube) collected via medical chart review / participants’ report
Timepoint [3] 423063 0
Assessed at the conclusion of the study
Secondary outcome [4] 423064 0
Duration of non-oral feeding (# days) using Nasogastric Tube/ Percutaneous Endoscopic Gastrostomy Tube, collected via medical chart review / participant's report
Timepoint [4] 423064 0
Assessed at the conclusion of the study
Secondary outcome [5] 423066 0
Quantity of bed days in hospital (general ward and ICU) collected from National Minimum Dataset. (Source: Ministry of Health New Zealand).
Timepoint [5] 423066 0
Assessed at the conclusion of the study.
Secondary outcome [6] 423067 0
Quantity of instrumental swallowing evaluation using Videofluoroscopic Swallowing Study (VFSS) collected via medical chart review.
Timepoint [6] 423067 0
Assessed at the conclusion of the study
Secondary outcome [7] 423068 0
Healthcare professionals' time (other than speech-language pathologist) involved in Videofluoroscopic Swallowing Study (VFSS). The outcome will be collected via medical chart review (#minutes).
Timepoint [7] 423068 0
Assessed at the conclusion of the study
Secondary outcome [8] 423074 0
Quantity of chest x-ray per participant via medical chart review.
Timepoint [8] 423074 0
Assessed at the conclusion of the study
Secondary outcome [9] 423075 0
Total cost of nutritional supplements estimated from the Pharmaceutical Collection., (Source: Ministry of Healthy New Zealand).
Timepoint [9] 423075 0
Assessed at the conclusion of the study.
Secondary outcome [10] 423077 0
Hospital event cost weight per participant as estimated from the National Minimum Dataset. (Source: Ministry of Health New Zealand).
Timepoint [10] 423077 0
Assessed at the conclusion of the study.
Secondary outcome [11] 423083 0
Rating of stroke disability as measured by Modified Rankin Scale (mRS)
Timepoint [11] 423083 0
-initial study enrolment (baseline)
-inpatient rehabilitation discharge
-6 months post initial study enrolment
Secondary outcome [12] 423084 0
Swallowing-related quality of life measured using the SWAL-QOL (McHorney et al., 2002)
Timepoint [12] 423084 0
-initial study enrolment (baseline)
-inpatient rehabilitation discharge
-6 months post initial study enrolment
Secondary outcome [13] 423085 0
Health-Related Quality of Life measured using the EuroQoL 5 dimension 5 levels (EQ-5D-5L)(Golicki et al., 2015)
Timepoint [13] 423085 0
-initial study enrolment (baseline)
-acute hospital discharge
-inpatient rehabilitation discharge
-6 months post initial study enrolment.
Secondary outcome [14] 423086 0
The mHealth App Usability Questionnaire for Interactive mHealth Apps (Patient Version) (Zhou et al., 2019).
Timepoint [14] 423086 0
-initial study enrolment (baseline)
-inpatient rehabilitation discharge
-6 months post initial study enrolment
Secondary outcome [15] 423087 0
Swallowing-related quality of care as measured by SWAL-CARE (McHorney et al., 2002).
Timepoint [15] 423087 0
-initial study enrolment (baseline)
-inpatient rehabilitation discharge
-6 months post initial study enrolment
Secondary outcome [16] 423911 0
Diet level, as measured by 8-level International Dysphagia Diet Standardization Initiative (IDDSI) framework (Steele et al., 2018)
Timepoint [16] 423911 0
-initial study enrolment (Baseline),
-every 5 days in the acute hospital and inpatient-rehabilitation hospital,
-every 10 days in the community post hospital discharge for 2 months,
-thereafter every 20 days in community up to a maximum of 6 months.
Secondary outcome [17] 423912 0
Number of days in acute hospital care [Christchurch Hospital] as collected via National Minimum Dataset / participants’ report in the community.
Timepoint [17] 423912 0
Assessed at the conclusion of the study.
Secondary outcome [18] 423913 0
Number of times transferred to higher-level hospital care (e.g., Christchurch Hospital) from different settings (e.g., Burwood hospital, home/ community settings) as collected via medical chart review / National Minimum Dataset / InterRAI Collection /participants’ report in the community. (Source: Ministry of Health New Zealand).
Timepoint [18] 423913 0
Assessed at the conclusion of the study.
Secondary outcome [19] 423914 0
Clinician time (Christchurch Hospital /Burwood Hospital /community speech-language pathologist) (#minutes) as written in the clinician medical notes.
Timepoint [19] 423914 0
-initial study enrolment (Baseline),
-every 5 days in the acute hospital and inpatient-rehabilitation hospital,
-every 10 days in the community post hospital discharge for 2 months,
-thereafter every 20 days in community up to a maximum of 6 months.
Secondary outcome [20] 423915 0
Researcher time when delivering intervention (accumulation of the time spent on assessment, support, and adjusting treatment dosage) (# minutes) as written in the researcher notes.
Timepoint [20] 423915 0
-initial study enrolment (Baseline),
-every 5 days in the acute hospital and inpatient-rehabilitation hospital,
-every 10 days in the community post hospital discharge for 2 months,
-thereafter every 20 days in community up to a maximum of 6 months.
Secondary outcome [21] 423916 0
Quantity of instrumental swallowing evaluation using Fiberoptic Endoscopic Evaluation of Swallowing (FEES) collected via medical chart review.
Timepoint [21] 423916 0
Assessed at the conclusion of the study
Secondary outcome [22] 423917 0
Healthcare professionals time (Other than speech-language pathologist) involved in Fiberoptic Endoscopic Evaluation of Swallowing). The outcome will be collected via medical chart review (#minutes).
Timepoint [22] 423917 0
Assessed at the conclusion of the study
Secondary outcome [23] 423918 0
Amount of speech-language pathologist time for instrumental swallowing assessment during Videofluoroscopic Swallowing Study (VFSS). The outcome will be collected via medical chart review (#minutes)
Timepoint [23] 423918 0
Assessed at the conclusion of the study
Secondary outcome [24] 423919 0
Amount of speech-language pathologist time for instrumental swallowing assessment during Fiberoptic Endoscopic Evaluation of Swallowing (FEES). The outcome will be collected via medical chart review (#minutes)
Timepoint [24] 423919 0
Assessed at the conclusion of the study
Secondary outcome [25] 423920 0
Quantity of Nasogastric Tube or Percutaneous Endoscopic Gastrostomy tube insertion per participant as collected from medical chart review / participants’ report in the community
Timepoint [25] 423920 0
Assessed at the conclusion of the study
Secondary outcome [26] 423921 0
Cost of equipment for Nasogastric Tube or Percutaneous Endoscopic Gastrostomy tube insertion per participant, estimated from Pharmac Medical Device List or participant self-report in the community. (Source: https://pharmac.govt.nz/hospital-devices/devices-list/).
Timepoint [26] 423921 0
Assessed at the conclusion of the study
Secondary outcome [27] 423922 0
Cost of drugs for Nasogastric Tube or Percutaneous Endoscopic Gastrostomy tube insertion per participant, estimated from Pharmaceutical Collection or participant self-report in the community. (Source: Ministry of Health New Zealand).
Timepoint [27] 423922 0
Assessed at the conclusion of the study
Secondary outcome [28] 423923 0
Cost of x-rays for Nasogastric Tube or Percutaneous Endoscopic Gastrostomy tube insertion per participant, estimated from Pharmac Medical Device List or participant self-report in the community. (Source: https://pharmac.govt.nz/hospital-devices/devices-list/).
Timepoint [28] 423923 0
Assessed at the conclusion of the study
Secondary outcome [29] 423924 0
Total cost of medications per participant estimated by Pharmaceutical Collection. (Source: Ministry of Health New Zealand).
Timepoint [29] 423924 0
Assessed at the conclusion of the study..
Secondary outcome [30] 423925 0
Amount of healthcare worker time (other than Speech-Language Pathologist) when managing participant during hospital stay. The outcome will be collected via medical chart review (#minutes).
Timepoint [30] 423925 0
-initial study enrolment (Baseline),
-every 5 days in the acute hospital and inpatient-rehabilitation hospital,
-every 10 days in the community post hospital discharge for 2 months,
-thereafter every 20 days in community up to a maximum of 6 months.
Secondary outcome [31] 423926 0
Amount of healthcare worker time (other than Speech-Language Pathologist) when managing participant in the community. The outcome will be collected via medical chart review /participants’ report (#minutes).
Timepoint [31] 423926 0
-initial study enrolment (Baseline),
-every 5 days in the acute hospital and inpatient-rehabilitation hospital,
-every 10 days in the community post hospital discharge for 2 months,
-thereafter every 20 days in community up to a maximum of 6 months.
Secondary outcome [32] 423927 0
Amount of caregiver time assisting participants in the hospital. The outcome will be collected via caregivers’ written report (#minutes).
Timepoint [32] 423927 0
-initial study enrolment (Baseline),
-every 5 days in the acute hospital and inpatient-rehabilitation hospital,
-every 10 days in the community post hospital discharge for 2 months,
-thereafter every 20 days in community up to a maximum of 6 months.
Secondary outcome [33] 423928 0
Amount of caregiver time assisting participants in the community. The outcome will be collected via caregivers’ written report (#minutes).
Timepoint [33] 423928 0
-initial study enrolment (Baseline),
-every 5 days in the acute hospital and inpatient-rehabilitation hospital,
-every 10 days in the community post hospital discharge for 2 months,
-thereafter every 20 days in community up to a maximum of 6 months.
Secondary outcome [34] 426772 0
Participants’ lived experience of using intensive, app-based swallowing skill training explored via phenomenological semi-structured interviews.
Timepoint [34] 426772 0
-hospital discharge (Christchurch / Burwood Hospital)
-6 months post initial study enrolment.
Secondary outcome [35] 427067 0
Cost of Chest X-ray will be estimated from Pharmac Medical Device List (Source: https://pharmac.govt.nz/hospital-devices/devices-list/).
Timepoint [35] 427067 0
Assessed at the conclusion of the study.

Eligibility
Key inclusion criteria
-adults aged 18 or over who have been hospitalized with acute stroke (any stroke type or lesion location).
-presenting with new onset dysphagia, per hospital/health care system diagnostic procedure.
-consent to shaving the submental surface area during study treatment/assessment to ensure adhesion of the electrode patch.
-internet access at study location (e.g., hospital/ home setting/nursing residence)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-presence of other neurological condition.
-deemed legally blind.
-presence of tracheostomy tube.
-inability to provide informed consent with aphasia-friendly documents

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were independently determined for each of the primary outcome variables via a simulation-based power analysis. The values for the control group across timepoints were inferred from previous studies by Girod-Roux (2023) and Crary et al. (2014). Slopes and interaction effects for the treatment group were predicted from other relevant literature.

The estimated differences across timepoints for ingestion efficiency and swallowing frequency measures were analysed using linear mixed effects models performed via the lme4 package (Bates et al., 2015). Survival analysis was used for the final primary outcome (FOIS). The largest estimated sample size was selected to ensure that all primary outcomes were adequately powered. Therefore, with consideration of potential drop out, this study will recruit up to 60 participants to achieve a p-value for the interaction effects smaller than 0.05, with a power above 80%.

For participant interviews, it is expected that data saturation will occur with a group of 12 participants or fewer (Bradbury-Jones et al., 2017; Guest et al., 2006). Therefore, this study will recruit 12 participants from the treatment group to interview at two timepoints (e.g., discharge from hospital and discharge from study).

Data analysis will be performed in RStudio (version 3.2.5) using the packages lme4 and lmerTest (Bates, Maechler, & Bolker, 2012). Linear mixed effect models will be used to explore the effects of treatment group and time point on the primary outcome measures where the residual error has a Gaussian distribution. The outcome variables will be compared between the baseline (T0) and three timepoints: discharge from acute hospital care (T1); discharge from inpatient rehabilitation (T2); and discharge from the study (T3). For the survival analysis, frequent assessments are needed to ensure this time-to-event analysis is sensitive to detect the diet changes across time. Thus, additional time points within the four primary timepoints are scheduled. In the event when participant drop out after hospitalization reduces sample size considerably, descriptive analysis of residual data will be used to investigate the treatment effect in community settings.

A random sample of 20% of the data set will be used for intra-rater and inter-rater reliability testing. Both rating will be evaluated using Type 3 intra-class correlation coefficients (ICC 3,1) with standard error measurement. Clinical measures with an ICC = 0.75 will be accepted as having a good test-retest reliability (Koo & Li, 2016).

For health economics analysis, within-trial effectiveness will be modelled using the primary health economic outcome measures and quality of life measures. Cost associated with the development and delivery of the intervention will be estimated as will participants utilization of pharmaceuticals and hospital/outpatient services. Subsequently, the associated cost related to dysphagia management for both treatment and control group will be estimated, allowing comparison to be made. The health economic analysis will include cost-effectiveness, acceptability, cost-savings, and expected net loss curves to inform future decisions related to the optimal strategy at any threshold for different subgroups.

Usability and participant satisfaction data will be analysed via descriptive statistical analysis. For the participant interviews, audio recordings of the semi-structured interviews will be transcribed and analysed descriptively using Braun and Clarke’s (2006) six phase, thematic analysis model. Throughout this process, trustworthiness and credibility will be ensured by having joint discussion among the research team (Nowell, Norris, White, & Moules, 2017).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/12/2023
Actual
27/12/2023
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
60
Accrual to date
50
Final
Recruitment outside Australia
Country [1] 25598 0
New Zealand
State/province [1] 25598 0
Canterbury

Funding & Sponsors
Funding source category [1] 313661 0
University
Name [1] 313661 0
University of Canterbury
Country [1] 313661 0
New Zealand
Funding source category [2] 314287 0
Commercial sector/Industry
Name [2] 314287 0
Swallowing Technologies Limited
Country [2] 314287 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
Country
New Zealand
Secondary sponsor category [1] 316231 0
None
Name [1] 316231 0
Address [1] 316231 0
Country [1] 316231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312828 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 312828 0
Ethics committee country [1] 312828 0
New Zealand
Date submitted for ethics approval [1] 312828 0
23/06/2023
Approval date [1] 312828 0
13/10/2023
Ethics approval number [1] 312828 0
2023 FULL 13944

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126062 0
Mr Jia Hao Foong
Address 126062 0
UC Rose Centre for Stroke Recovery and ResearchSt George’s medical centreLeinsters Chambers level one248 Papanui Road, MerivaleChristchurch, 8014New Zealand
Country 126062 0
New Zealand
Phone 126062 0
+64033692385
Fax 126062 0
Email 126062 0
[email protected]
Contact person for public queries
Name 126063 0
Ruth Flynn
Address 126063 0
UC Rose Centre for Stroke Recovery and ResearchSt George’s medical centreLeinsters Chambers level one248 Papanui Road, MerivaleChristchurch, 8014New Zealand
Country 126063 0
New Zealand
Phone 126063 0
+64 3 369 1786
Fax 126063 0
Email 126063 0
[email protected]
Contact person for scientific queries
Name 126064 0
Jia Hao Foong
Address 126064 0
UC Rose Centre for Stroke Recovery and ResearchSt George’s medical centreLeinsters Chambers level one248 Papanui Road, MerivaleChristchurch, 8014New Zealand
Country 126064 0
New Zealand
Phone 126064 0
+64033692385
Fax 126064 0
Email 126064 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all de-identified participant data collected during the trial
When will data be available (start and end dates)?
The data will be available upon the project completion (completion of data analysis and thesis write-up). Tentatively will be available by 2026 for up to 10 years.
Available to whom?
Available to future researchers with ethics approval
Available for what types of analyses?
meta-analysis
How or where can data be obtained?
Researcher may request data from UC Rose Centre for Stroke Recovery and Reserarch via emailing [email protected]. The deidentified data will be stored in a password-protected drive for 10 years after the completion of study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19464Study protocol  [email protected]
19466Informed consent form  [email protected]
19524Other  [email protected] Health and Disability Ethics Committees Scientific... [More Details]



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