Evaluation and Implementation of Digital Health Ecosystem in Academic Health Center

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaval University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Integrated Digital Health Ecosystem

    Device

    Participants 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 intervention

    Participants 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

60 Participants
are divided into 2 treatment groups
Group A: Digital Health EcosystemExperimental treatment 1 intervention
Group B: Usual Primary CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
6 months
2

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.

Time frame
6 months
3

Technology acceptance

measured using a Technology Acceptance Model (TAM)-based questionnaire

Time frame
6 months

Secondary outcomes

1

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).

Time frame
Baseline and 6 months
2

Physical activity level

Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire.

Time frame
Baseline, 3 months, and 6 months
3

Motivation toward physical activity

Motivation toward physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire (BREQ-2).

Time frame
Baseline, 3 months, and 6 months
4

Patient activation

Patient activation and self-management will be assessed using the Patient Activation Measure (PAM-13).

Time frame
Baseline and 6 months

Other outcomes

1

Waist circumference

Waist circumference will be measured using a measuring tape and reported in centimeters (cm).

Time frame
Baseline and 6 months
2

Body weight

body weight will be measured using a calibrated digital scale and reported in kilograms (Kg).

Time frame
Baseline and 6 months
3

Glycated hemoglobin (HbA1c)

Glycated hemoglobin (HbA1c) will be measured from blood samples and reported as a percentage (%).

Time frame
Baseline and 6 months
4

Systolic blood pressure

Systolic blood pressure will be measured using an automated blood pressure monitor and reported in millimeters of mercury (mmHg).

Time frame
Baseline and 6 months

Sponsors and contacts

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Laval University

Lead sponsor

Canadian Space Agency

Collaborator

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