Randomized Controlled Trial of a Mobile Phone-based Telemonitoring Application for Self-management and Clinical Decision Support for Patients With Complex Chronic Conditions
Phase: NA
Conditions: Heart Failure, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease, Uncontrolled Hypertension, Diabetes
Sponsor: University Health Network, Toronto

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Title: 
Effects of Remote Patient Monitoring on Chronic Disease Management 
 
NCT Number:  
NCT03127852 
 
Document Date:  
May 29, 2019 
 
 

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Research Study Protocol 
 
 
Title 
Randomized controlled trial of a mobile phone-based 
telemonitoring application for self-management and 
clinical decision support for patients with complex 
chronic conditions 
 
Investigator 
Dr. Emily Seto, PhD PEng 
 
IHPME, University of Toronto 
 
Centre for Global eHealth Innovation, University 
Health Network 
 
emily.seto@utoronto.ca 
 
416-669-9295 
 
Co-Investigators 
Dr. Heather Ross, MD FRCPC 
 
Heart Function Clinic, University Health Network 
 
Heather.ross@uhn.ca 
 
(416) 340-3482 
 
 
Dr. Alexander Logan, MD FRCPC 
 
Lunenfeld-Tanenbaum Research Institute, Mount 
Sinai Hospital 
 
alogan@mtsinai.on.ca 
 
(416) 586-4800 ext.5187 
 
 
Dr. Kenneth Chapman, MD FRCPC 
Asthma and Airway Centre 
Toronto Western Hospital 
 
kchapman@ca.inter.net 
 
(416) 603-5499 
 
 
Dr. Deborah Casey, MD FRCPC  
Asthma and Airway Centre 
Toronto Western Hospital 
 
deborah.casey@uhn.ca 
 
(416) 603-5499 
 

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Dr. Joseph Cafazzo, PhD PEng 
 
Centre for Global eHealth Innovation, University 
Health Network 
 
Joe.cafazzo@uhn.ca 
 
416-340-3634 
 
Study Coordinator 
Patrick Ware, MPH 
 
Institute of Health Policy, Management and 
Evaluation, University of Toronto 
 
Patrick.ware@mail.utoronto.ca 
 
514-449-2250 
 
 
 
 
 
 

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Abstract 
 
The rising prevalence of chronic illnesses threatens the sustainability of the 
healthcare system, especially due to the high cost of frequent hospitalizations. 
Effective self-management of chronic disease can reduce the need for urgent 
care but helping patients to master complex decision-making and to implement 
lifestyle changes is difficult. Telemonitoring systems are a promising adjunct in 
this regard. Such systems allow patients to monitor their physiological state (e.g. 
weight, blood pressure) and to receive both automated and real-time feedback 
from health care providers. Current systems tend to be inconvenient and costly to 
implement in existing clinical settings and are often limited to the monitoring of 
one chronic condition. We believe that delivering telemonitoring through a mobile 
phone will enable patients with complex chronic conditions to track their health, 
receive automated feedback relevant to their unique situations, and improve 
communication with their health care team in a cost effective and intuitive way.  
 
In order to test the effectiveness of the intervention, we propose a 6-month 
randomized controlled trial of 146 patients. The study will include patients with a 
diagnosis of any of the following conditions or combinations of these conditions: 
heart failure, chronic obstructive pulmonary disease, chronic kidney disease, 
and/or uncontrolled hypertension. Insulin-requiring diabetes will be included as a 
co-morbidity to be supported by the telemonitoring application if the patient also 
has at least one of the four above chronic conditions. Patients will be assigned to 
either (1) the control group receiving usual care, or (2) the group using the mobile 
telemonitoring system in addition to usual care. We hypothesize that our mobile 
intervention will be a cost-effective and scalable tool that will improve health 
outcomes and quality of care, while empowering and reassuring patients and 
their family. 
 
 
 
 
 

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Background 
 
Patients with chronic illnesses, including those with multiple chronic conditions 
(MCCs), face numerous challenges in the self-management of their conditions, 
particularly complex decision-making, varying and often contradictory clinical 
management advice, and frequent hospitalizations. A 2011 Canadian Institute for 
Health Information study found that three out of four Canadians age 65 and older 
reported having at least one chronic condition, while one in four seniors reported 
having three or more (1). While 75% of health care dollars are solely devoted to 
managing chronic illnesses, 5% of the population consumes > 50% of all 
dollars devoted to healthcare (2).  With the increasing prevalence of chronic 
illnesses and MCCs (1), the sustainability of our healthcare system is threatened. 
However, through enhanced patient self-care and clinical management, 
significant reductions in healthcare spending and improved health outcomes 
could be achieved. 
 
eHealth tools may empower patients and their informal caregivers in more 
effective self-management of MCCs, and serve as a critical decision-support tool 
for their healthcare providers (HCP). In particular, telemonitoring enables patients 
to track their vital signs and symptoms, and also to receive automated instruction 
and clinical intervention during “teachable moments” (i.e., clear actions are 
provided when the context is most appropriate).  The automated instructions can 
be based on current physiological measurements, self-monitored symptoms, and 
readily analyzed trends in both (3). Automated real-time alerts and frequently 
collected and analyzed physiological data can also support clinical decisions by 
healthcare providers (3). 
 
A growing body of research on telemonitoring interventions for single chronic 
conditions exists, but it focuses on singular conditions such as diabetes, 
hypertension, or heart failure (4-6). Several studies and systematic reviews have 
shown that the use of telemonitoring interventions for the management of chronic 
conditions (e.g., heart failure, hypertension and diabetes) lead to positive health 
outcomes and significant reductions in healthcare costs (7-11). Contradictory 
studies that did not find improvements often excluded a self-care component, 
were difficult to use, or did not target patients who were the most ill and 
frequently hospitalized (12-15). Due to the added complexity involved, very few 
studies have focused on the use of telemonitoring amongst high-risk patients 
with MCC, even though these patients may benefit the most from such an 
intervention (16-21).  
 
Based on our existing telemonitoring tools and extensive experience in 
evaluating such technologies focused on patients with chronic conditions, we 
propose conducting an investigation of the use of mobile phone-based 
telemonitoring for the self-management of complex patients. The rationale for the 
use of mobile phones is that it enables a cost-effective data hub that allows 

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patients to transmit physiological and symptom information from any location with 
cell phone reception.  
 
For our project, complex patients will be defined as those who are at high-risk for 
hospitalization, exacerbations, and disease progression, as well as patients with 
multiple chronic conditions. In particular, heart failure (HF) and chronic 
obstructive pulmonary disease (COPD) are among the most common causes of 
avoidable hospitalizations (22), and CKD patients incur very high costs when 
hemodialysis is required (23, 24). Thus, delaying the need for hemodialysis 
through eHealth tools would improve patient quality of life and defer substantial 
health service utilization. In addition, improving self-care of patients prior to 
requiring hemodialysis may result in patients later opting for more independent 
interventions, such as home hemodialysis. 
 
 
Objectives 
 
The objective of the randomized controlled trial (RCT) is to evaluate a mobile 
phone-based telemonitoring system for management of a variety of chronic 
conditions, including HF, COPD, CKD, insulin-requiring diabetes and 
uncontrolled hypertension in specialty clinic settings. The RCT will be registered 
into clinicaltrials.gov and ISRCTN.org prior to commencement. 
 
The telemonitoring system, named “Medly”, has been developed through 
leveraging technology and accumulated expertise in the development and clinical 
trials of mobile telemonitoring systems in the areas of hypertension, diabetes, 
asthma, heart failure (HF), chronic obstructive pulmonary disease (COPD), and 
chronic kidney disease (CKD) (3, 4, 25-32).  The development and usability 
testing of Medly for this RCT was completed under the University Health Network 
research ethics board approval number 13-7085-BE. Research ethics board 
approval numbers for trials using this telemonitoring platform that have been 
conducted at the University Health Network include 08-0192-BE (HF RCT), 14-
7638 (CKD pilot), and 14-7756-AE (COPD pilot).  
 
Central Research Question: What is the impact of a telemonitoring system for 
patients with complex chronic illnesses on health status, cost, self-management, 
clinical management, health outcomes, and health service utilization?  
 
 
 
 
 
 
Patient Population 
Inclusion Criteria 

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Patients who meet the following criteria will be considered for inclusion in the 
study: 
• Adults (age 18 years or older) 
• Diagnosed with HF, COPD, CKD, insulin-requiring diabetes and/or 
uncontrolled hypertension  
• Followed by at least one of the following physicians: 
o Followed by a cardiologist at the Heart Function Clinic, University 
Health Network, who has primary responsibility for management of 
the patient’s HF 
o Followed by a respirologist at the Asthma and Airway Centre, 
University Health Network, who has primary responsibility for 
management of the patient’s COPD 
o Followed by Dr. Alexander Logan or another hypertension 
specialist at the Mount Sinai Hospital, who has primary 
responsibility for management of the patient’s CKD and/or 
hypertension 
o Followed by an endocrinologist at the Endocrinology Clinic at UHN, 
such as Dr. Phil Segal. 
• Patients with HF as the primary chronic disease: 
o Patients with HF with reduced ejection fraction (EF<0.40) 
• Patients with COPD as the primary chronic disease:  
o Spirometrically confirmed diagnosis of COPD of GOLD Stage II or 
higher (defined as post-bronchodilator FEV1 < 80% predicted and 
FEV1/FVC ratio < 70%) and, 
o smoking history of ³ 20 pack-years or homozygous alpha-1 
antitrypsin deficiency and, 
o Prescribed an action plan for the early self-treatment of acute 
exacerbations 
• Patients with CKD as the primary chronic disease: 
o Grade 3-5 (eGFR < 60mL/1.73 m2) 
• Patients with uncontrolled hypertension as the primary chronic disease: 
o For non-diabetics: blood pressure >=140/90 mmHg auscultatory 
(manual measurement) or >=135/85 mmHg oscillometric 
(automated measurement) 
o For diabetics: blood pressure >=130/80 mmHg 
• Patient or their caregiver speaks and reads English adequately to provide 
informed consent and understand the text prompts in the application. 
• Ability to comply with using the telemonitoring system (e.g, able to stand 
on the weight scale, able to answer symptom questions, etc.). 

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Exclusion Criteria 
Patients will be excluded from participating in the pilot study for any of the 
following reasons: 
• Patients on mechanical circulatory support 
• Patients on the heart transplant list 
• Terminal diagnosis with life expectancy < 1 year 
• Dementia or uncontrolled psychiatric illness 
• Resident of a long term care facility  
 
Patient Recruitment 
 
Patients will be recruited during regularly scheduled visits to the UHN and Mount 
Sinai Hospital clinics associated with their chronic illnesses. After the clinician 
determines that the patient is eligible for recruitment, he/she will ask the patient if 
they are willing to speak to the study coordinator regarding the study. All eligible 
participants, based on the inclusion/exclusion criteria above, will be asked to sign 
a written consent form prior to being enrolled in the study (Appendix 1). 
 
An additional recruitment strategy to asking patients if they are interested in 
participating in the study during their regularly scheduled clinic visit may be 
employed to speed up patient enrolment. This recruitment strategy has 
previously been used with great success for a completed and a current study at 
the University Health Network by Dr. Alexander Logan (co-investigator) at the 
Renal Clinic. It involves identifying interested patients prior to their clinic visit.  
The research study coordinator, an independent third party who is not part of the 
clinical care team, will generate an eligible patient mail out list.  This list will be 
derived from the general clinic roster at the Hypertension Clinic (Mount Sinai 
Hospital) and at the Heart Function Clinic (UHN); the list will be screened and 
verified by the clinic nurses/physicians to ensure appropriateness (as determined 
by the study inclusion criteria) for mailing out invitations about the study. A 
separate REB amendment will be sent to the Mount Sinai Hospital REB. The mail 
out study invitation will be used in order to determine interest of patients who are 
not scheduled for an upcoming clinic visit at UHN.  After identifying eligible 
patients, the research coordinator will mail out an invitation letter including a 
study description and consent form along with a pre-addressed and stamped 
envelope to return the signed consent form to the clinic (see Appendix 2).  This 
will be mailed only to potential participants who have been reviewed by the clinic 
staff as “appropriate to be approached”. The letter will be mailed to the potential 
participants on behalf Dr. Alexander Logan for the Hypertension Clinic patients at 
Mount Sinai Hospital and Dr. Heather Ross for the Heart Function Clinic patients 
at the University Health Network. Each will sign the letter as they are the clinician 
leads in the respective clinics. The patients will also be provided with the 

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coordinator’s phone number in case they require additional information or want to 
discuss aspects of the study, as well as to indicate interest in the study. For 
those who did not respond to the letter within two weeks of mailing, the study 
coordinator will contact them over the phone to explain the study and determine 
interest in participating. For all those interested in participating, the study 
coordinator will arrange a date and time to meet in the clinic. Details of the study 
and the consent form will be reviewed in-person at this time to ensure that 
patients are fully informed about all aspects of the study and are freely providing 
their consent to participate.  
 
 
To perform a sample size calculation, the primary outcome measure SF-36 was 
used. Assuming a moderate effect size on the general health dimension of the 
SF-36 of 10.5 points (39), a score of 57 +/- 21 for the control group (40), 80% 
power, and alpha=0.05 (two-sided), the sample size per group was calculated to 
be 63 (http://clincalc.com/Stats/SampleSize.aspx). Assuming 15% of patients will 
be lost to follow-up (including mortality) (36, 37), the sample size per group is 73. 
Hence 146 patients will be enrolled during the trial and randomized 1:1 into 
control and telemonitoring groups. 
 
To perform the randomization, the online computer generated randomization tool, 
Research Randomizer, will be used (www.randomizer.org). The study 
coordinator performing the recruitment will be blinded until the patient has 
consented to participate. The participants will be blocked randomized (blocks of 
4) and stratified into groups according to their primary condition (HF, COPD, 
hypertension, insulin-requiring diabetes, and CKD). The HF group will further be 
stratified based on NYHA classification (NYHA class 2-3, NYHA class 4), and the 
hypertensive patients will be stratified to those with and those without diabetes. 
 
A member of the clinical care team (e.g., physician or nurse) will briefly introduce 
the study to the patient and ask if the patient would be willing to meet with the 
study coordinator.  If the patient agrees, the study coordinator will meet with the 
patient to discuss the study in more detail.  If the patient is interested in 
participating in the study, the coordinator will evaluate the patient for 
inclusion/exclusion criteria and obtain written consent for participation.  Once this 
is completed, the study coordinator will provide the patient and, if appropriate, 
his/her caregiver with training on the telemonitoring system.   
 
 
 
 
 
 
Telemonitoring Technology 
 
Medly will enable patients with complex chronic illnesses, including MCCs, to 
take clinically relevant physiological measurements with wireless home medical 

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devices and to answer symptom questions on the mobile phone. The 
measurements will be automatically and wirelessly transmitted to the mobile 
phone and then to a data server. Specifically, patients with HF will monitor daily 
weight and blood pressure/heart rate, CKD patients will monitor blood pressure, 
diabetes patients will monitor blood glucose and HF, COPD, and CKD patients 
will monitor symptoms. Hypertension patients will monitor their blood pressure. 
Automated self-care instructions/messages that have been carefully developed 
with healthcare specialists will be sent to the patient based on the readings and 
reported symptoms. If there are signs of their status deteriorating, an alert will be 
sent to a clinician that is responsible for the particular chronic condition of 
concern (i.e., in the specific specialty clinic). The clinicians will have all the 
relevant patient data sent to them and will be able to access (through a secure 
web portal) to view historical and trending data for their patients. Additional app 
features will also be available, such as educational videos for proper inhaler use 
for COPD patients. 
 
Methods 
 
The control group will receive usual care, and the intervention group will receive 
usual care plus the telemonitoring intervention. Both groups will be followed for 6 
months. Study data collection will occur during regularly scheduled visits, no 
additional study visits beyond what patients experience in usual care, it is 
anticipated that patients will be recruited, randomized, and trained during a 
routine scheduled clinics. If this proves inconvenient for the patient, an additional 
study visit may be scheduled at their convenience. Similarly, we anticipate 
collecting the study equipment and administer the follow up questionnaire at a 
regularly scheduled visit. Each intervention study participant will be provided with 
a smartphone. This phone will be loaded with the application and a limited data 
plan to enable data transfer. Patients will also be provided with relevant home 
medical monitoring devices (e.g., weight scales and blood pressure monitors for 
HF patients, blood pressure monitors for CKD and hypertension patients, and 
blood glucose meters for diabetes patients). Patients will be asked to take 
measurements and record symptoms at a specified frequency at their homes. 
Home measurement depends on the specific chronic condition(s). HF, COPD, 
and diabetes are generally monitored daily whereas hypertension and CKD are 
generally monitored several times per week as specified by the algorithm 
developed in conjunction with specialists. Patients will be notified when they 
should take at home measurement through the application.  
The research team, as informed by the patient’s clinician(s), will enter patient-
specific baseline information into the telemonitoring system dashboard, such as 
individual target weight ranges, target blood pressure ranges, medication lists, 
COPD action plan, etc.  
 
Outcome Measures:  
The primary outcome will be health status as measured with SF-36 because this 
metric will be relevant to all chronic conditions under investigation. A secondary 

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outcome measure will be the cost (from the health system and patient 
perspectives). The cost of healthcare will include hospitalizations, emergency 
department (ED) visits, clinic visits, delay of hemodialysis commencement, 
medications, and telemonitoring program, as relevant to the different chronic 
illnesses and will include disease-specific sub-analyses.   
 
Other secondary outcome measures will include combined hospitalization for any 
reason or death from any cause within 6-months after enrolment, hospitalization, 
mortality, days in hospital, number of emergency department (ED) and clinic 
visits, and medications. Secondary outcome measures will also include general 
quality of life as measure by the EuroQol 5D-RL, anxiety and depression as 
measure with the Hospital Anxiety and Depression Scale (41) and patients’ self-
efficacy to self-manage their disease as measured with the Self-Efficacy for 
Managing Chronic Disease Scale (42) (Appendix 3). 
 
Disease specific outcome measures will include: 
• HF 
o left ventricular ejection fraction (LVEF) 
o brain natriuretic peptide (BNP)  
o self-care as measured by the Self-Care of Heart Failure Index (43) 
(Appendix 4) 
o Heart-failure specific quality of life as measured by Minnesota 
Living with Heart Failure Questionnaire (44) (Appendix 4) 
o Shortness of breath as measure using a visual analogue scale 
(VAS) for dyspnea (Appendix 4) 
o Blood work: creatinine, sodium, potassium, hemoglobin, urate 
o Prognostic score as determined by the Seattle Health Failure Model 
(requires: age, gender, NYHA class, weight, ejection fraction, 
systolic BP, medication list (including diuretics), lab results 
(hemoglobin, lymphocytes, uric acid, total cholesterol, sodium) and 
QRS interval) 
• COPD 
o forced expiratory volume in one second (FEV1) 
o symptoms score from the telemonitoring system 
o COPD Assessment Test (CAT) score (45) (Appendix 5) 
o COPD-specific knowledge after 6-months of application usage, as 
measured by the Bristol COPD Knowledge Questionnaire 
(BCKQ)(46) (Appendix 5) 
o patient self-efficacy at 6 months as measured by the COPD Self-
Efficacy Scale (CSES)(47) (Appendix 5) 
o COPD severity as measured by the BODE Index(48) at 6 months 
(Appendix 5) 

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• CKD 
o estimated glomerular filtration rate (eGFR)  
o symptoms score from the telemonitoring system 
o blood pressure as measured by an automatic blood pressure 
monitor 
• Hypertension 
o blood pressure as measured by an automatic blood pressure 
monitor 
o average 7-day blood pressure  
• Diabetes 
o HgbA1c 
 
 
Data Acquisition: Number of hospitalizations, days in hospital, number of ED 
and clinic visits, and medications will be determined through the hospital EMR 
and a manual chart review of all participants’ clinical records. Combined 
hospitalization will be verified by patient participants through self-report with the 
help of a questionnaire.  The cost of the intervention will be tracked, including for 
equipment costs and human resources for clinical support, technical support, and 
program management. Standard cost values for a day in-hospital, ED visit, etc. 
will be used to estimate net cost savings or expenditures. Values for pre- and 
post-trial health outcome measures (eg, blood test results) will be obtained 
through hospital clinical records or through the Medly database for symptoms. 
Pre- and follow up questionnaires (baseline, 1-month, and 6-months), will be 
administered to both control and intervention groups that contain the validated 
survey tools listed above. Participants will be able to complete the questionnaires 
at the clinic or complete it at home. Participants that chose to complete the 
questionnaire at home will be given a pre-paid self-addressed envelope to mail 
the questionnaire back to the study team. The 1-month questionnaire will be 
given to participants upon enrolment with instructions to complete the 
questionnaire one month after starting the trial and to mail it back to the study 
team using the pre-paid envelope. The study coordinator will call each participant 
at the 1-month period to remind participants to complete the questionnaire. In 
addition to the baseline and follow up questionnaires that are applicable to all 
patient participants (Appendix 3), patients with HF and/or COPD will also receive 
the validated survey tools listed above (Appendix 4 and 5). Average 7-day blood 
pressure will also be recorded from patients with a primary diagnosis of 
hypertension during their first week in the study (baseline) and their last week in 
the study (6-months). To do this, patients will be provided with a digital blood 
pressure monitor which they will use to take blood pressure 4 times per day (2 
times in the morning and 2 times in the evening) over each 7-day period. Patients 
will return the blood pressure monitor to the study team who will download the 

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data and calculate the average 7-day blood pressure value. Usage data, in terms 
adherence to taking measurements and use of the different features, will also be 
data-mined from the servers. 
 
In addition to the quantitative metrics, all participants will be asked basic 
questions such as their self-care practice and their thoughts on remote patient 
monitoring at the start of the study. A subgroup of the intervention arm will also 
be interviewed individually to assess their experiences and perceptions regarding 
the use of Medly at the end of the study. The number of patients that will 
interviewed will depend on when saturation of information is reached, typically 
15-20 participants. The interviews will be conducted in a quiet and private space 
within a clinic (e.g., consultation room or education room). Prior to the interview, 
participants will be informed that notes will be taken and they will be audio taped 
for data analysis. See Appendix 6 for sample patient interview questions. The 
clinicians involved in the trial will also be asked to participate (see Appendix 7 for 
clinician consent form) in interviews to determine their perceptions of Medly. See 
Appendix 8 for sample clinician interview questions. 
 
All study data will be kept for 10 years after the completion of the study and then 
destroyed by shredding of paper or erasing of digital information. 
 
Data Analysis: Post-trial data and change scores will be compared between the 
control and intervention groups using independent Student t tests and Mann–
Whitney tests (for normally and not normally distributed data, respectively). 
Paired Student t tests and Wilcoxon signed rank tests will be performed to 
compare baseline and post-study data within the control and telemonitoring 
groups. The statistical analyses will be performed using the statistical software 
application SPSS (IBM Corporation, USA). The cost evaluation will be performed 
by comparing any savings through reductions in hospitalization, emergency and 
clinic visits, through the use of the intervention. This will further include 
amortizing the equipment costs and factoring in additional clinical, technical, and 
management resources. An analysis of indirect costs will also be performed, 
such as days absent from work. Interview data will be analyzed using a 
conventional content analysis approach (49). Two researchers will analyze the 
transcripts independently and code the transcripts with the software program 
NVivo (QSR International, Doncaster, Victoria, Australia).  
 
The Principle Investigator will keep all study data in a secure and confidential 
location for 10 years after the completion of the study and then they will 
destroyed by shredding of paper or erasing of digital information. All participants 
will be assigned a unique identifier, which will replace any identifiable information 
contained in the research data.  A list linking the study number with the 
participants’ name will be kept by the Principle Investigator in a secure place in a 
locked cabinet. 
 
 

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Benefits to Being in the Study 
By participating in this study, patients will have the opportunity to experience 
using a new application that is not yet available on the market and is part of an 
original approach to improving chronic illness management. Patients will also 
have the opportunity to learn more about their chronic conditions and its 
treatment as well as strategies to improve their health and quality of life. The 
intervention itself may or may not provide benefits to their health outcomes. 
 
Benefits to Society 
The information gathered during this study will help us learn if and how a mobile 
telemonitoring system improves the self-care, clinical management, and health 
outcomes of those with complex chronic conditions. This trial may lead to 
evidence that supports sustained telemonitoring programs that improves health 
outcomes and reduces costs to our healthcare system for management of 
chronic conditions. 
 
Compensation 
 
Patients will be compensated for their participation in the study with a $25 
Shoppers Drug Mart gift card, this will be offered once at the time of recruitment. 
Clinicians will not receive any form of compensation for participating in this study. 
 
 
Dissemination Strategy 
 
We plan to disseminate our findings through publications in appropriate scientific 
journals and through presentations at appropriate scientific conferences. We also 
plan to disseminate summarized results understandable to a lay audience to 
study participants directly and through general media so that those outside the 
study may take advantage of any such tools developed as a result of this study.   
 
Budget 
 
Funding for this project is available through a successful grant application to the 
CIHR eHealth Catalyst Grant. For a detailed budget for this RCT, please see 
Appendix 9.  
 
 
 

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