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DEFINITIONS
Trial Review
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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
15/01/2024
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
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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
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Secondary ID [1]
309466
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
stroke
329725
0
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dysphagia
330376
0
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swallowing impairment
330377
0
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Condition category
Condition code
Physical Medicine / Rehabilitation
326626
326626
0
0
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Speech therapy
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Stroke
327454
327454
0
0
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Haemorrhagic
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Stroke
327455
327455
0
0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
326338
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Treatment: Devices
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Intervention code [2]
326339
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Treatment: Other
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Intervention code [3]
326340
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Rehabilitation
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
335101
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Yes/No binary outcome regarding participants return to preadmission diet measured by the Functional Oral Intake Scale (FOIS) (Crary et al., 2005)
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Assessment method [1]
335101
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Timepoint [1]
335101
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-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
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Primary outcome [2]
335102
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Solid ingestion efficiency as measured by ‘ingestion time (seconds)’ via Test of Masticating and Swallowing Solids (ToMaSS) (Huckabee & Lamvik-Gozdzikowska, 2018)
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Assessment method [2]
335102
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Timepoint [2]
335102
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-initial study enrolment (baseline)
-acute hospital discharge
-inpatient rehabilitation discharge
-6 months post initial study enrolment.
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Primary outcome [3]
335103
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Fluid ingestion efficiency as measured by ‘swallowing capacity(mL/swallow)’ via Timed Water Swallowing Test (TWST) (Hagglund et al.., 2022).
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Assessment method [3]
335103
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Timepoint [3]
335103
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-initial study enrolment(baseline)
-acute hospital discharge
-inpatient rehabilitation discharge
-6 months post initial study enrolment
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Secondary outcome [1]
423061
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Number of swallows produced at rest (Spontaneous Swallowing Frequency [SSF]) (Crary et al.,2013) - Primary Outcome 4
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Assessment method [1]
423061
0
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Timepoint [1]
423061
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-initial study enrolment(baseline)
-acute hospital discharge
-inpatient rehabilitation discharge
-6 months post initial study enrolment
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Secondary outcome [2]
423062
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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).
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Assessment method [2]
423062
0
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Timepoint [2]
423062
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Assessed at the conclusion of the study.
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Secondary outcome [3]
423063
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Presence of non-oral feeding (Nasogastric Tube/ Percutaneous Endoscopic Gastrostomy Tube) collected via medical chart review / participants’ report
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Assessment method [3]
423063
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Timepoint [3]
423063
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Assessed at the conclusion of the study
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Secondary outcome [4]
423064
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Duration of non-oral feeding (# days) using Nasogastric Tube/ Percutaneous Endoscopic Gastrostomy Tube, collected via medical chart review / participant's report
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Assessment method [4]
423064
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Timepoint [4]
423064
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Assessed at the conclusion of the study
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Secondary outcome [5]
423066
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Quantity of bed days in hospital (general ward and ICU) collected from National Minimum Dataset. (Source: Ministry of Health New Zealand).
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Assessment method [5]
423066
0
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Timepoint [5]
423066
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Assessed at the conclusion of the study.
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Secondary outcome [6]
423067
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Quantity of instrumental swallowing evaluation using Videofluoroscopic Swallowing Study (VFSS) collected via medical chart review.
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Assessment method [6]
423067
0
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Timepoint [6]
423067
0
Assessed at the conclusion of the study
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Secondary outcome [7]
423068
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Healthcare professionals' time (other than speech-language pathologist) involved in Videofluoroscopic Swallowing Study (VFSS). The outcome will be collected via medical chart review (#minutes).
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Assessment method [7]
423068
0
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Timepoint [7]
423068
0
Assessed at the conclusion of the study
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Secondary outcome [8]
423074
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Quantity of chest x-ray per participant via medical chart review.
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Assessment method [8]
423074
0
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Timepoint [8]
423074
0
Assessed at the conclusion of the study
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Secondary outcome [9]
423075
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Total cost of nutritional supplements estimated from the Pharmaceutical Collection., (Source: Ministry of Healthy New Zealand).
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Assessment method [9]
423075
0
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Timepoint [9]
423075
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Assessed at the conclusion of the study.
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Secondary outcome [10]
423077
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Hospital event cost weight per participant as estimated from the National Minimum Dataset. (Source: Ministry of Health New Zealand).
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Assessment method [10]
423077
0
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Timepoint [10]
423077
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Assessed at the conclusion of the study.
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Secondary outcome [11]
423083
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Rating of stroke disability as measured by Modified Rankin Scale (mRS)
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Assessment method [11]
423083
0
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Timepoint [11]
423083
0
-initial study enrolment (baseline)
-inpatient rehabilitation discharge
-6 months post initial study enrolment
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Secondary outcome [12]
423084
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Swallowing-related quality of life measured using the SWAL-QOL (McHorney et al., 2002)
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Assessment method [12]
423084
0
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Timepoint [12]
423084
0
-initial study enrolment (baseline)
-inpatient rehabilitation discharge
-6 months post initial study enrolment
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Secondary outcome [13]
423085
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Health-Related Quality of Life measured using the EuroQoL 5 dimension 5 levels (EQ-5D-5L)(Golicki et al., 2015)
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Assessment method [13]
423085
0
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Timepoint [13]
423085
0
-initial study enrolment (baseline)
-acute hospital discharge
-inpatient rehabilitation discharge
-6 months post initial study enrolment.
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Secondary outcome [14]
423086
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The mHealth App Usability Questionnaire for Interactive mHealth Apps (Patient Version) (Zhou et al., 2019).
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Assessment method [14]
423086
0
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Timepoint [14]
423086
0
-initial study enrolment (baseline)
-inpatient rehabilitation discharge
-6 months post initial study enrolment
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Secondary outcome [15]
423087
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Swallowing-related quality of care as measured by SWAL-CARE (McHorney et al., 2002).
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Assessment method [15]
423087
0
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Timepoint [15]
423087
0
-initial study enrolment (baseline)
-inpatient rehabilitation discharge
-6 months post initial study enrolment
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Secondary outcome [16]
423911
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Diet level, as measured by 8-level International Dysphagia Diet Standardization Initiative (IDDSI) framework (Steele et al., 2018)
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Assessment method [16]
423911
0
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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.
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Secondary outcome [17]
423912
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Number of days in acute hospital care [Christchurch Hospital] as collected via National Minimum Dataset / participants’ report in the community.
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Assessment method [17]
423912
0
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Timepoint [17]
423912
0
Assessed at the conclusion of the study.
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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).
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Assessment method [18]
423913
0
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Timepoint [18]
423913
0
Assessed at the conclusion of the study.
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Secondary outcome [19]
423914
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Clinician time (Christchurch Hospital /Burwood Hospital /community speech-language pathologist) (#minutes) as written in the clinician medical notes.
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Assessment method [19]
423914
0
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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.
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Secondary outcome [20]
423915
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Researcher time when delivering intervention (accumulation of the time spent on assessment, support, and adjusting treatment dosage) (# minutes) as written in the researcher notes.
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Assessment method [20]
423915
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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.
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Secondary outcome [21]
423916
0
Quantity of instrumental swallowing evaluation using Fiberoptic Endoscopic Evaluation of Swallowing (FEES) collected via medical chart review.
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Assessment method [21]
423916
0
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Timepoint [21]
423916
0
Assessed at the conclusion of the study
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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).
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Assessment method [22]
423917
0
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Timepoint [22]
423917
0
Assessed at the conclusion of the study
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Secondary outcome [23]
423918
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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)
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Assessment method [23]
423918
0
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Timepoint [23]
423918
0
Assessed at the conclusion of the study
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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)
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Assessment method [24]
423919
0
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Timepoint [24]
423919
0
Assessed at the conclusion of the study
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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
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Assessment method [25]
423920
0
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Timepoint [25]
423920
0
Assessed at the conclusion of the study
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Secondary outcome [26]
423921
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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/).
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Assessment method [26]
423921
0
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Timepoint [26]
423921
0
Assessed at the conclusion of the study
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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).
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Assessment method [27]
423922
0
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Timepoint [27]
423922
0
Assessed at the conclusion of the study
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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/).
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Assessment method [28]
423923
0
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Timepoint [28]
423923
0
Assessed at the conclusion of the study
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Secondary outcome [29]
423924
0
Total cost of medications per participant estimated by Pharmaceutical Collection. (Source: Ministry of Health New Zealand).
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Assessment method [29]
423924
0
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Timepoint [29]
423924
0
Assessed at the conclusion of the study..
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Secondary outcome [30]
423925
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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).
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Assessment method [30]
423925
0
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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.
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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).
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Assessment method [31]
423926
0
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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.
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Secondary outcome [32]
423927
0
Amount of caregiver time assisting participants in the hospital. The outcome will be collected via caregivers’ written report (#minutes).
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Assessment method [32]
423927
0
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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.
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Secondary outcome [33]
423928
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Amount of caregiver time assisting participants in the community. The outcome will be collected via caregivers’ written report (#minutes).
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Assessment method [33]
423928
0
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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.
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Secondary outcome [34]
426772
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Participants’ lived experience of using intensive, app-based swallowing skill training explored via phenomenological semi-structured interviews.
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Assessment method [34]
426772
0
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Timepoint [34]
426772
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-hospital discharge (Christchurch / Burwood Hospital)
-6 months post initial study enrolment.
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Secondary outcome [35]
427067
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Cost of Chest X-ray will be estimated from Pharmac Medical Device List (Source: https://pharmac.govt.nz/hospital-devices/devices-list/).
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Assessment method [35]
427067
0
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Timepoint [35]
427067
0
Assessed at the conclusion of the study.
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-presence of other neurological condition.
-deemed legally blind.
-presence of tracheostomy tube.
-inability to provide informed consent with aphasia-friendly documents
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
26/12/2023
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Actual
27/12/2023
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Date of last participant enrolment
Anticipated
26/09/2024
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Actual
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Date of last data collection
Anticipated
26/03/2025
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Actual
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Sample size
Target
60
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Accrual to date
3
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Final
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Recruitment outside Australia
Country [1]
25598
0
New Zealand
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State/province [1]
25598
0
Canterbury
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Funding & Sponsors
Funding source category [1]
313661
0
University
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Name [1]
313661
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University of Canterbury
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Address [1]
313661
0
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
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Country [1]
313661
0
New Zealand
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Funding source category [2]
314287
0
Commercial sector/Industry
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Name [2]
314287
0
Swallowing Technologies Limited
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Address [2]
314287
0
249 Papanui Road, Strowan, Christchurch 8014
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Country [2]
314287
0
New Zealand
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Primary sponsor type
University
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Name
University of Canterbury
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Address
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
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Country
New Zealand
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Secondary sponsor category [1]
316231
0
None
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Name [1]
316231
0
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Address [1]
316231
0
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Country [1]
316231
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312828
0
Southern Health and Disability Ethics Committees
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Ethics committee address [1]
312828
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Health and Disability Ethics CommitteesMinistry of Health133 Molesworth Street PO Box 5013Wellington, 6011
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Ethics committee country [1]
312828
0
New Zealand
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Date submitted for ethics approval [1]
312828
0
23/06/2023
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Approval date [1]
312828
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13/10/2023
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Ethics approval number [1]
312828
0
2023 FULL 13944
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Summary
Brief summary
Dysphagia (swallowing impairment) is common after stroke, and frequently associated with poor health and quality of life outcomes. This poses significant clinical and financial burden on the health-care system. Skill-based swallowing training is an emerging approach, with positive outcomes among patients with neurological disorders. Yet, this approach has not been explored in patients with post-stroke dysphagia (PSD) across the progression of their stroke journey. Furthermore, clinical applicability of skill-based training may be limited by various barriers in current health settings (e.g., large caseloads, limited resources, and poor access to medical services). Swallowing treatment delivered using mobile health applications may overcome these barriers.
This study will longitudinally evaluate the effectiveness of intensive, app-based swallowing skill training in PSD, across hospital and community settings. Up to 60 participants presenting with new onset PSD at Christchurch Hospital will be recruited. Participants will be enrolled in this clinical trial up to a maximum period of 6 months. Participants will be allocated into two groups. The control group will receive usual dysphagia management (UDM) provided by the treating clinicians, whereas participants in the treatment group will similarly receive UDM with additional app-based swallowing skill-based training. The skill-based treatment will be delivered twice daily, 5 days per week. Researchers will remotely monitor and modify the treatment dosage, to reflect individuals’ performance across settings.
Study Outcomes: Participants in both groups will be assessed at regular time intervals across the 6 months period. The outcome variables will be compared between baseline (T0) with three time points: discharge from acute hospital care (T1); discharge from inpatient rehabilitation setting (T2); and discharge from the study (T3).
The primary outcomes include current dietary status and functional swallowing performance. Secondary outcomes include food and liquid consistency, presence and frequency of dysphagia-related complications and procedures, cost-benefit data, and quality of life measures. Medical chart will be reviewed to explore the biographical/demographical/medical status variables for input into the health economics analysis. Survey questionnaires will be administered to evaluate the usability and satisfaction towards this approach. Additionally, patient experience of using the swallowing skill-based app will be explored via semi-structured interviews.
Hypothesis: Participants in the treatment group receiving intensive, app-based swallowing skill training will have greater improvement than the control group. This supports evidence suggesting that high-intensive treatment, provided during the critical period may augment the natural, heightened process of stroke recovery, ultimately promote adaptive neural plasticity and improve treatment outcomes, post-hospitalisation.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Mr Jia Hao Foong
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Address
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UC Rose Centre for Stroke Recovery and ResearchSt George’s medical centreLeinsters Chambers level one248 Papanui Road, MerivaleChristchurch, 8014New Zealand
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Country
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New Zealand
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Phone
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+64033692385
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Fax
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Email
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[email protected]
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Contact person for public queries
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Mrs Ruth Flynn
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Address
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UC Rose Centre for Stroke Recovery and ResearchSt George’s medical centreLeinsters Chambers level one248 Papanui Road, MerivaleChristchurch, 8014New Zealand
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Country
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New Zealand
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Phone
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+64 3 369 1786
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Jia Hao Foong
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Address
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UC Rose Centre for Stroke Recovery and ResearchSt George’s medical centreLeinsters Chambers level one248 Papanui Road, MerivaleChristchurch, 8014New Zealand
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Country
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New Zealand
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Phone
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+64033692385
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
all de-identified participant data collected during the trial
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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.
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Available to whom?
Available to future researchers with ethics approval
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Available for what types of analyses?
meta-analysis
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
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Citation
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Other Details
Attachment
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Study protocol
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Informed consent form
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19524
Other
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Health and Disability Ethics Committees Scientific...
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Results publications and other study-related documents
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