About this trial
Mobile health technologies, such as smartwatches, wearable sensors, and digital applications, have the potential to support healthier lifestyles and improve the management of health conditions. These technologies can collect information on physical activity, sleep, heart rate, heart rate variability, respiratory rate, and other health indicators. However, integrating data from these devices into routine health care and electronic health records remains challenging, particularly in primary care settings and remote communities.
The purpose of this study is to evaluate the implementation and feasibility of an integrated digital health ecosystem that combines wearable monitoring using smartwatches with a secure digital platform. The ecosystem is designed to collect, transmit, and display health information in a way that may support patients, health care providers, and researchers.
Participants will use wearable technologies and complete questionnaires while health-related information is collected through the digital platform. The study will assess the usability, acceptability, interoperability, and feasibility of implementing this technology in real-world settings, including primary care clinics and remote communities. The study will also explore the potential use of wearable-derived physiological data to support the assessment, monitoring, and management of physiological and psychological stress.
The knowledge gained from this study may help improve the integration of digital health technologies into routine care, support self-management and preventive health strategies, and facilitate access to health monitoring in underserved environments. Findings may also contribute to the development of digital health solutions for isolated and extreme environments, including future space exploration missions.
This research aligns with priorities identified by the Canadian Space Agency to advance technologies that support safe, healthy, and productive human activities in remote and extreme environments on Earth and during future space missions beyond low Earth orbit.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 years or older.
Registered patient receiving care at the participating primary care clinic (GMF-U Saint-Charles-Borromée).
Have at least one stable chronic medical condition or cardiovascular risk factor requiring longitudinal follow-up.
Able to safely engage in physical activity, as determined by their treating healthcare provider.
Disqualifiers
Severe cognitive impairment or any condition preventing informed consent or study participation.
Unstable or acute medical condition requiring immediate treatment or hospitalization.
Medical contraindication to participating in physical activity, as determined by the treating healthcare
Inability to use the digital health platform or wearable device despite appropriate support.
Trial design
Parallel
Treatments tested in this trial
Integrated Digital Health Ecosystem
DeviceParticipants will use an integrated digital health ecosystem that combines wearable technology, remote health monitoring, a secure digital platform, and personalized lifestyle medicine support. The system enables the collection, transmission, visualization, and integration of health-related information to support patient self-management and communication with healthcare providers during the 6-month study period.
Usual Primary Care
Other interventionParticipants will receive routine primary care according to standard clinical practice throughout the 6-month study period without access to the digital health ecosystem.
Treatment groups
Trial outcomes
Primary outcomes
Appropriateness of the digital health ecosystem assessed using the Intervention Appropriateness Measure (IAM)
Appropriateness of the digital health ecosystem will be assessed using the Intervention Appropriateness Measure (IAM), a 4-item questionnaire. Each item is rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree). The four item scores will be averaged to generate a mean score ranging from 1 to 5, with higher scores indicating greater perceived appropriateness of the intervention (the digital health ecosystem).
Usability of the digital health ecosystem assessed using the System Usability Scale (SUS)
Usability of the digital health ecosystem will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire. Items are rated on a 5-point Likert scale. Item scores are converted and summed to generate an overall score ranging from 0 to 100, with higher scores indicating greater perceived usability of the digital health ecosystem.
Technology acceptance
measured using a Technology Acceptance Model (TAM)-based questionnaire
Secondary outcomes
Lifestyle medicine behaviours
Lifestyle medicine behaviours across the six pillars will be assessed using a French lifestyle medicine questionnaire inspired by the American College of Lifestyle Medicine (ACLM).
Physical activity level
Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire.
Motivation toward physical activity
Motivation toward physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire (BREQ-2).
Patient activation
Patient activation and self-management will be assessed using the Patient Activation Measure (PAM-13).
Other outcomes
Waist circumference
Waist circumference will be measured using a measuring tape and reported in centimeters (cm).
Body weight
body weight will be measured using a calibrated digital scale and reported in kilograms (Kg).
Glycated hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) will be measured from blood samples and reported as a percentage (%).
Systolic blood pressure
Systolic blood pressure will be measured using an automated blood pressure monitor and reported in millimeters of mercury (mmHg).
Sponsors and contacts
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Laval University
Lead sponsor
Canadian Space Agency
Collaborator
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