Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04698499 |
Other study ID # |
HREBA.CC-21-0054 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 27, 2021 |
Est. completion date |
October 1, 2023 |
Study information
Verified date |
January 2024 |
Source |
University of Alberta |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Dysphagia affects 22% of those over the age of 50, which equates to 250 million people
worldwide and 360,000 in Alberta. At high risk are survivors of head and neck cancer (70%).
Difficulties with swallowing are not only life threatening and resource-intense, but also
socially limiting. To regain swallowing function and avoid or reduce the consequences of
dysphagia, patients require regular, intensive therapy over many months to strengthen
swallowing muscles and improve swallow coordination. This therapy is often coupled with
visual biofeedback that uses surface electromyography (sEMG). Despite evidence that
swallowing exercises are effective when provided with an intensive regimen and when coupled
with sEMG biofeedback, patients rarely receive it.
The primary aim of this work is to determine whether the use of a mobile system equipped with
sEMG biofeedback affects adherence to home-based swallowing exercises. The secondary aim of
this work is to determine if the exercise program results in improved patient reported
outcomes related to dysphagia and nutrition. Our tertiary aim is to determine if previous
findings of adherence can be replicated.
Sixty adults with oropharyngeal dysphagia secondary to OPSCC treatment will be enrolled in
the study. This study will follow a cross over randomized design such that all participants
will be provided with both types of treatment: using pen and paper (Treatment Arm A) and
using the mobile health system (Treatment Arm B).
Description:
Background Dysphagia affects 22% of those over the age of 50 [1], which equates to 250
million people worldwide and 360,000 in Alberta [2]. At high risk are survivors of head and
neck cancer (70%), stroke patients (78%), people with Parkinson's disease (82%) and those
who've had a traumatic brain injury (65%) [3]. Left untreated, dysphagia has serious health
consequences, such as malnutrition, aspiration pneumonia, and even death. The associated
longer hospital stays and complications result in an estimated annual burden of care of $547
billion in USA [4]. In Alberta, managing just one consequence of dysphagia (aspiration
pneumonia) in patients with head and neck cancer and stroke costs the healthcare system $2.53
million CAD a year [5]. Difficulties with swallowing are not only life threatening and
resource-intense, but also socially limiting. Patients with dysphagia avoid social situations
that involve eating, are disproportionately affected by depression, and miss more than 3
times the number of workdays than individuals without swallowing difficulties.
To regain swallowing function and avoid or reduce the aforementioned consequences of
dysphagia, patients require regular, intensive therapy over many months to strengthen
swallowing muscles and improve swallow coordination. This therapy is often coupled with
visual biofeedback that uses surface electromyography (sEMG). sEMG biofeedback lets patients
know how hard their muscles are contracting and for how long during a given exercise. sEMG
biofeedback is used to teach patients how to perform exercises correctly, elicit maximum
effort, and demonstrate incremental improvements in performance.
Despite evidence that swallowing exercises are effective when provided with an intensive
regimen and when coupled with sEMG biofeedback, patients rarely receive it. This limited
access stems from poor patient and clinician resources. For patients, getting to the clinic
to access a clinician and the equipment is inconvenient and costly. In order to cope with
limited patient engagement, clinicians are more likely to manage dysphagia by providing diet
modifications, by prescribing feeding tubes, and by giving patients maneuvers and exercises
on a printed sheet of paper. These approaches to the management of dysphagia are inadequate
to meet the needs of patients. Furthermore, a recent systematic review found that average
adherence to dysphagia management recommendations was between 22% and 52% [6]. With the
advent of strict distancing restrictions during the COVID-19 pandemic, remote care via
telerehabilitation or mobile health (mHealth) technologies has received increased attention.
AIMS: The primary aim of this work is to determine whether the use of a mobile system
equipped with sEMG biofeedback affects adherence to home-based swallowing exercises.
The secondary aim of this work is to determine if the exercise program results in improved
patient reported outcomes related to dysphagia and nutrition. Our tertiary aim is to
determine if previous findings of adherence can be replicated.
Mobile swallowing system selected for study The Mobili-T is a mobile swallowing exercise
system for patients with swallowing difficulties. This mHealth system can be used by patients
for home-based swallowing exercises. It is comprised of a mobile device, a smartphone patient
app, and a clinician portal. The patient wears the mobile device during exercise. The mobile
device uses clinical grade surface electromyography (sEMG) and sticks under the chin with a
medical-grade double-sided adhesive. The sEMG hardware comes with a charging dock that
doubles as a carrying case.
The sEMG signal is wirelessly transmitted to the smartphone app. Here, the sEMG is shown to
the patient as visual biofeedback, where the deflection of the biofeedback signal reflects
the strength and duration of muscle contraction. The muscles monitored are found under the
chin (submental area) and are those targeted during typical swallowing rehabilitation. The
app uses a smart software that walks patients through a set of clinically proven swallowing
exercises [7,8], uses a back-end algorithm to detect whether or not the sEMG signal collected
was elicited by a swallow (as opposed to other extraneous movements such as head movements),
and calculates effort targets based on the patient's abilities. Clinicians can remotely
monitor patient progress, adherence, and adjust prescriptions.
One of the unique aspects of Mobili-T is that the investigators have involved patients and
clinicians in the design from the inception of the project. The investigators also have
conducted usability and feasibility research testing [9-13]. Our feasibility study was a
quasi-experimental pretest-posttest trial with 20 patients with dysphagia secondary to head
and neck cancer (submitted for publication). The investigators evaluated whether or not
patients could successfully complete swallowing therapy using the Mobili-T at home under the
remote clinical supervision of our speech language pathologist. The investigators found that
adherence rates to home-based swallowing exercise remained at or above 72% over a six week
treatment period and that dysphagia-specific quality-of-life improved following this six week
treatment program. However, the study had limitations that precluded us from understanding
whether the observations noted were a result of the use of the technology or a result of
participant attitude and motivation in being part of a study.
Our aim with the present study is to determine if our previous findings can be replicated,
and also to identify if these findings are unique to the use of an mHealth technology. We are
also interested in whether patient-reported nutrition and health change throughout the
treatment block.
To address these objectives, we will have two conditions within the study: 1) home-based
dysphagia exercise using the current gold standard of printed instructions and a diary to
track adherence, and 2) home-based dysphagia exercises using an mHealth system to provide
biofeedback and track exercise completion. To ensure that all patient participants have
equitable access to both conditions, a cross over randomized design will be used such that
all participants will be provided with both types of treatment-delivery methods. This study
design was previously used by Mertens et al. (2016) to determine if a mobile application
improves therapy adherence rates in elderly patients undergoing rehabilitation [14].
The specific objectives of our study are as follows:
Objective 1 (i.e., primary objective). Determine if adherence to home-based swallowing
exercises is different when a mobile system equipped with sEMG biofeedback is used versus pen
and paper (diary format).
Hypothesis 1. There is no difference in average weekly adherence between the experimental
group (mHealth system) and the control group (pen and paper).
Hypothesis 2. There is no difference in average daily exercise dose (total # of exercise
trials completed in the treatment block/ number of days in the treatment block) between the
experimental group (mHealth system) and the control group (pen and paper).
Objective 2. Determine if the exercise program results in improved patient reported outcomes
related to dysphagia, nutrition, and health.
Hypothesis 3. There is no difference in patient-reported outcomes on the MD Anderson
Dysphagia Inventory (MDADI), caloric intake, and health between the experimental group
(mHealth system) and the control group (pen and paper).
Objective 3: Determine if previous findings related to adherence and patient-reported
swallowing outcomes can be replicated.
Hypothesis 4. Average weekly adherence rates to home-based swallowing exercise will remain at
or above 72% over a six week treatment period. Twenty-five percent of participants will
experience a minimally important differences in their pre- and post-therapy
dysphagia-specific quality-of-life scores.
General study details for ITA A total of 60 patient participants will be recruited, 30 per
study arm. The study will last 3 months and one week (or 13 weeks). However, the study will
remain open until all participants have been recruited and have completed the trial (expected
to take 1 year). Sample size calculation is detailed below, in section 1.3.
Participants 1.1 Recruitment. Participants will be recruited through speech-language
pathologists (SLPs) at the University of Alberta Hospital, Cross Cancer Institute, Institute
for Reconstructive Sciences in Medicine, Home Nutrition Support Program, Foothills Medical
Center, Tom Baker Cancer Center and Central Alberta Cancer Center. Participants will be
identified by their SLPs. Participants also will be recruited from a pool of individuals who
have contacted the research team during the feasibility trial or following media events,
wishing to be notified about upcoming trials. Participants will be consecutively recruited
until the sample size is achieved.
Recruitment An email alert (found in Documents) will be sent to physicians and
speech-language pathologist (SLPs) in the province known to work with head and neck cancer
patients. They will be told which patients are eligible for this study and will be provided
information about the study. SLPs will also be provided with the study poster and study flyer
so that they can share these with interested patients. Hence, participants will be identified
by their physicians or speech-language pathologist (SLP) and recommended for swallowing
therapy to the research group.
Patients who are referred to the study by their SLP and are interested in participating will
be asked by their referring clinician to complete the Consent to Recruit/ Be Contacted form
(found in Documents). This form will be passed on to the Research Clinician by the referring
clinician. Consent To Be Contacted by Researcher Form has an expiry date listed on the form.
Participants also will be recruited from a pool of individuals who have contacted the
research team during the feasibility trial, through word of mouth, or following media events,
wishing to be notified about upcoming trials. They will be alerted of the study via an email
(found in Documents) and the study recruitment poster. The study flyer will be shared only
with anyone who is interested. If these patients express an interest in participating, they
will still require a referral from their own attending SLPs (i.e., community clinicians).
Participants will be enrolled in the study if they have a diagnosis of oropharyngeal
dysphagia secondary to HNC treatment. The patient's present or past SLP will be used as a
source of referral and validation that the patient is a good candidate for home based
swallowing exercise using the effortful and/or the Mendelsohn swallows.
For patients unknown to the investigators first, they will NOT be contacted directly until
patients have provided consent to do so. Patients will be approached by their attending
clinicians (physicians or SLPs). Clinicians will let patients know that a study is currently
underway. They will share the title of the study, study poster, and study flyer with the
patient and ask them if it is okay for a Research Clinician (Dr. Gabriela Constantinescu) to
contact them with more information.
The Research Clinician will contact the patient and ask them if they are still interested in
participating. If yes, she will share the letter of information and consent form
electronically (either emailed to the patient or to their SLP). A second call will be
scheduled and the Research Clinician will then go over the letter of information with the
patient in detail. If the patient is still interested in the study, 3 appointments in
Edmonton will be booked. Consent will be obtained in person, at the first visit.
If the patient affirms on the phone however, that they are no longer interested in the study,
the patient's contact information will be shredded. Occasionally, patients may request to be
contacted at a later date due to personal reasons. In this scenario, contact information will
be kept in a secure location until the sample size for the study is reached. At that time, if
the patient has not been contacted/ booked, their contact information will be shredded.
None of the study coordinators /investigators/ research clinician are directly involved in
the patients' care. Patients may simply tell their attending clinicians that they are not
interested in hearing further details about the study and the Research Clinician will not be
aware of this information. Patients will be reminded by the Research Clinician that
participation is voluntary and that care will not be affected in any way by their decision.
Any callback list is not publicly displayed. It will be kept in the study binder (in a locked
room at the University of Alberta) until shredded as detailed above. The Research Clinician,
Dr. Gabriela Constantinescu, will look after contact information of patients expressing
interest, until shredded as detailed above.
1.2 Inclusion/ Exclusion Criteria. Participants will be enrolled in the study if they have a
diagnosis of oropharyngeal dysphagia secondary to treatment for squamous cell carcinoma
(OPSCC). SCCs make up 90% of all HNCs. Participants will be consecutively recruited, until
the sample size is achieved. Participants will be recruited any time 3 months or later
post-surgery or post-(chemo)radiation therapy. This time frame was selected to avoid
duplication of services for patients who may receive swallowing therapy during their
radiation therapy and to target patients with chronic and stable dysphagia. Participants will
be included: 1) if they have received treatment for head and neck cancer (e.g., +/-surgery,
+/-radiation therapy, +/- chemotherapy), 2) if their attending speech-language pathologist
has confirmed from a Modified Barium Swallow (MBS) assessment or Fiberoptic Endoscopic
Evaluation of Swallowing (FEES) that the patient is a candidate for the effortful swallow
and/or the Mendelsohn maneuver therapy. These exercises are used routinely in clinical
practice and target specific physiological impairments of the swallow that are common to
OPSCC patients. Participants will be excluded: 1) if they have a history of cognitive delay,
2) a history of stroke or traumatic brain injury, and 3) if they cannot reliably navigate the
Mobili-T system after the training session, and 4) if their SLP confirms planned swallowing
exercises or procedures to address dysphagia like esophageal dilation. Participants also will
be excluded if they have a beard that they are not willing to shave or partially shave (as
the device adheres under the chin, on the surface of the skin). Finally, participants will be
excluded if they are unable to travel to Edmonton 3 times during a 3 month period).
In addition, in keeping with contraindications listed on the Mobili-T labeling, patient
participants will be excluded if they: have an implanted electronic device of any kind,
including cardiac pacemakers or similar assistive devices, electronic infusion pumps, and
implanted stimulators; if they have irritated skin or skin with open wounds under the chin;
if they have an allergy to silver.
1.3 Sample Size. No previous literature exists on a clinically significant difference in
adherence or dose to guide sample size calculation. The researchers used a previous study
[15] to guide our sample size selection. In the cited study, a total of 79 OPSCC patients
were randomized to 3 treatment arms (26 or 27 patients participants per arm), where one of
the treatment arms included swallowing therapy using an app. As the present study has 2
treatment arms, we will recruit 52 to 60 participants.
In addition, we have consulted an epidemiologist regarding sample size calculation. The
following calculator was used:
http://hedwig.mgh.harvard.edu/sample_size/js/js_crossover_quant.html along with the following
parameters: 0.05 significance level, two-sided, within patient standard deviation of 35.5
[6], power of 0.9, and a minimal detectable difference in means of 22. This sample size
calculation is based on the primary objective.
2.0 General Procedure: Sixty adults with oropharyngeal dysphagia secondary to OPSCC treatment
will be enrolled in the study. This study will follow a crossover randomized design (AB/BA)
such that all participants will be provided with both types of treatment: using the mobile
health system and using pen and paper. Randomized allocation will be determined using Sealed
Envelope, a Randomization and online database for clinical trials
(https://www.sealedenvelope.com/)
Once a patient expresses interest in the study/ is referred to the study by their clinician
(e.g., SLP), the Research Clinician, Dr. Gabi Constantinescu, will contact the participants
with more information and screening questions (e.g., do you have a beard?). An electronic or
hard copy version of the Letter of Information and Consent form will be shared with the
patient. The information and questions are meant to ensure that patients interested in the
study fit most exclusion/ inclusion criteria before traveling to Edmonton. If patient
participants self-refer to the study via word of mouth (and were not referred by their
attending SLPs), consent to contact the patient's attending SLP will be obtained before
participants are invited to Edmonton for their first appointment.
The patient's attending SLP will be contacted to ensure that services are not duplicated
elsewhere, that the patient is not booked for other procedures that may impact outcomes in
this trial (e.g., esophageal dilation), that a swallow assessment was recently completed and
that the SLP believes the patient will be a good candidate for the swallowing therapy offered
through this study.
All pre-, washout, and post-treatment sessions will take place in Edmonton.
2.1 Pre-treatment session. The Letter of Information and Consent will be reviewed again. The
MD Anderson Dysphagia Inventory (MDADI) and the Health Questionnaire (EuroQoL EQ-5D) (both
described in section 3.0 Outcome Measures) will be administered. Next, Dr. Constantinescu
will: (1) determine the order of treatment blocks for the participant (i.e., Group1 - AB, or
Group 2 - BA); (2) introduce the Mobili-T system (if applicable); (3) introduce the
swallowing exercises and allow time for practice; (4) explain the treatment block format and
associated documents.
The swallowing therapy exercises will be explained and practiced until patients can
demonstrate competency on their own. This ability is defined as the successful completion of
five consecutive trials of each exercise, where the success will be judged by clinical visual
inspection.
Participants will be sent home with the Three-Day Dietary Intake Record to complete and
return at their next appointment.
If patient participants are randomized to the Treatment Arm B with the mHealth system first,
then training with the system will occur in the presence of the Research Clinician and will
conclude once the patient appears comfortable with the device, has shown that he/ she can set
up the device and start the software independently, and has demonstrated competency with the
exercises. The Research Clinician in this study (i.e., registered SLP) will remotely monitor
the session data from participants who are using the mHealth system and will be available to
answer questions and troubleshoot technology issues. Patients will not be identified on the
device, app, or clinician portal. The app simply records the serial number on the device
hardware (e.g., 001). This is noted in the researcher's records (e.g., J Smith - 001).
Participants will further be identified by a participant code.
2.2 Treatment blocks A and B. Patients will be asked to practice at home for 3 months
targeting a daily total of 8 sets of 3 exercise types with 3 repetitions of each. The daily
total target will be 72 trials (8 sets * 3 exercise types * 3 repetitions of each). Exercise
type and dose will be the same for all participants, for a daily total of 24 regular saliva
swallows, 24 effortful saliva swallows, and 24 Mendelsohn maneuver saliva swallows. Treatment
Arm A will consist of using pen and paper to complete the exercises. This is considered
standard care. Treatment Arm B will consist of using Mobili-T to complete the exercises.
2.3 Post-treatment session. Following the first Treatment Arm (A or B), there will be a
one-week washout period. During this week, as well as following the second Treatment Arm, a
post-treatment session will be booked and the Three-Day Dietary Intake Record provided for
home completion. This session will consist of administering the MDADI, the Health
Questionnaire (EuroQoL EQ-5D), and either returning or providing the Mobili-T system.