Digital Health Interventione-IDEANCT07831837
Evaluation and Implementation of Digital Health Ecosystem in Academic Health Center
A study testing Integrated Digital Health Ecosystem and Usual Primary Care in people with Digital Health Intervention and Remote Consultation, Teleconsultation, run by Laval University at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Digital Health Intervention, Remote Consultation, Teleconsultation, Lifestyle Factors
- What is being tested?
- Integrated Digital Health Ecosystem and Usual Primary Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Sep 2026to 1 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Able to understand and communicate in English or French.
- Able and willing to provide written informed consent.
- Willing to comply with study procedures and scheduled follow-up visits.
Who cannot join
- 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.
- Any condition that, in the opinion of the investigator, would compromise the participant's safety or the integrity of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Université Laval
Québec, Quebec, G1V0A6
Caroline Rhéaume, MD, PhD, 418-656-2131, caroline.rheaume@fmed.ulaval.ca
Laïla Badr, MSc, 418-663-5313 ext. 12286, laila.badr.ciussscn@ssss.gouv.qc.ca
Caroline Rhéaume
Québec
About this study
Official title: Evaluation and Implementation of Digital Health Ecosystem in Primary Care and Remote Area and Space Exploration
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.
Read more
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.
Read the detailed description
The rapid evolution of digital health technologies has created new opportunities to support preventive care, patient self-management, and health care system transformation. Wearable devices, mobile applications, remote monitoring tools, and interoperable digital platforms can provide continuous health information that may support both patients and health care providers in making informed decisions. These technologies are particularly relevant for lifestyle medicine, chronic disease prevention, remote patient monitoring, and health care delivery in underserved environments.
Despite increasing adoption of wearable technologies by the general population, significant barriers remain to their effective integration into routine clinical practice. Challenges include limited interoperability between devices and electronic health records, difficulties integrating data into clinical workflows, concerns related to usability and acceptability, and uncertainty regarding implementation in real-world health care settings. These challenges may be even greater in rural and remote communities where access to health services is often limited.
The Evaluation and Implementation of a Digital Health Ecosystem (e-IDEA) study aims to evaluate the implementation and feasibility of an interoperable digital health ecosystem that integrates wearable monitoring technologies with a secure digital platform capable of collecting, transmitting, storing, and displaying health information. The ecosystem is intended to support communication between patients and health care providers while facilitating health monitoring, lifestyle interventions, and clinical decision-making.
The study is funded through the Canadian Space Agency and is aligned with national priorities related to the development of innovative health technologies capable of supporting human health in remote, isolated, and extreme environments. Technologies that facilitate autonomous health monitoring may play an important role not only in remote Earth-based settings but also in future long-duration space exploration missions where access to direct medical support is limited.
This project uses a Hybrid Type 1 Effectiveness-Implementation design, allowing simultaneous evaluation of implementation outcomes and selected health-related outcomes. The study will be conducted in primary care and remote care settings where participants will be provided access to the digital health ecosystem and wearable monitoring technologies. Participants will be randomized to receive either the integrated digital health ecosystem in addition to usual primary care or usual primary care alone.
Participants will use wearable devices capable of collecting physiological and lifestyle-related information. Data collected may include measures such as physical activity, sleep patterns, heart rate, heart rate variability, blood pressure, oxygen saturation, body temperature, and other health indicators available through the digital platform. Participants will also complete validated questionnaires assessing health status, lifestyle behaviours, patient activation, technology acceptance, usability, implementation outcomes, self-regulation, physical activity, and perceived stress.
An exploratory component of the study will focus on stress assessment and monitoring. Stress is increasingly recognized as an important determinant of physical and mental health, influencing cardiovascular health, sleep quality, cognitive performance, emotional well-being, and overall quality of life. Traditional approaches to stress assessment often rely on self-reported questionnaires and may not adequately capture fluctuations in stress over time, particularly in remote, isolated, or operational environments.
Wearable technologies enable the continuous collection of physiological and behavioral data, including heart rate, heart rate variability, sleep characteristics, physical activity, and other physiological measures that may provide objective indicators of stress. Because there is currently no universally accepted gold standard for stress assessment, combining wearable-derived physiological data with validated self-reported stress measures may provide a more comprehensive understanding of stress in real-world settings. The study will therefore explore the relationship between wearable-derived physiological data and validated self-reported measures of stress and evaluate the feasibility of developing artificial intelligence (AI) and machine-learning models capable of estimating perceived stress in real-world settings.
This exploratory objective is particularly relevant for primary care, remote communities, and isolated, confined, and extreme (ICE) environments, including future space missions where access to traditional psychological assessment and healthcare services may be limited. The knowledge generated may contribute to the development of autonomous health monitoring systems capable of supporting early identification of stress and informing future preventive interventions.
The study will generate evidence regarding the implementation of an interoperable digital health ecosystem in routine clinical practice, with particular emphasis on implementation processes, user experience, interoperability, and integration within primary care and remote healthcare settings.
Implementation outcomes will be evaluated using established implementation science frameworks, including the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, supported by quantitative and qualitative methods. Feedback from participants, healthcare providers, and other stakeholders will be used to identify barriers and facilitators to implementation, inform iterative refinement of the digital health ecosystem, and optimize future deployment. A strengths, weaknesses, opportunities, and threats (SWOT) analysis will complement these evaluations.
Patient engagement principles will be integrated throughout the project. Stakeholders, including patients and health care providers, will contribute to the evaluation of user experience, implementation processes, and recommendations for future deployment.
Knowledge generated through this study is expected to contribute to the evidence base supporting the integration of interoperable digital health technologies into routine care. Findings may inform future implementation strategies in primary care, rural and remote communities, virtual care programs, and other settings where access to health services is constrained.
Furthermore, the study will generate preliminary evidence regarding the use of wearable-derived physiological signals and artificial intelligence approaches to monitor stress in clinical and operational environments. These findings may support future research aimed at developing personalized and scalable stress-monitoring solutions for healthcare, remote environments, and space exploration.
In addition, the study will provide valuable insights regarding the use of digital health ecosystems in isolated, confined, and extreme environments. These findings may inform the future development of autonomous health monitoring systems for human space exploration beyond low Earth orbit, while simultaneously generating practical benefits for underserved populations on Earth.
- Conditions
- Digital Health Intervention, Remote Consultation, Teleconsultation, Lifestyle Factors, Stress, Primary Care Patients With Chronic Conditions, Space Analogue
- Being tested
- Integrated Digital Health Ecosystem, Usual Primary Care
- Keywords
- Digital Health Ecosystem, Digital Health Technology, Wearable Devices, Remote Patient Monitoring, Electronic Health Records, Mobile Health (mHealth), Interoperability, Lifestyle Medicine, Primary Care, Hybrid Effectiveness-Implementation Design, Patient Engagement, Telemedicine, Artificial Intelligence, Stress management, Heart Rate Variability, Remote Communities, Isolated, Confined and Extreme Environments (ICE), Space Medicine, Autnonomous Health Monitoring
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Digital Health EcosystemDevice
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 CareOther
Participants will receive routine primary care according to standard clinical practice throughout the 6-month study period without access to the digital health ecosystem.
| Study group | Role | What they receive |
|---|---|---|
| Digital Health Ecosystem | Experimental | Participants randomized to the intervention group will receive usual primary care in addition to a digital health ecosystem integrating wearable technology, remote health monitoring, and personalized lifestyle medicine support throughout the 6-month study period Receives: Device: Integrated Digital Health Ecosystem |
| Usual Primary Care | Active comparator | Participants randomized to the control group will receive usual primary care supported by the existing electronic health record system and will not receive the digital health ecosystem during the 6-month study period. Receives: Other: Usual Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
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.
Measured: 6 months
Technology acceptance
measured using a Technology Acceptance Model (TAM)-based questionnaire
Measured: 6 months
Secondary outcomes (9)
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).
Measured: Baseline and 6 months
Physical activity level
Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire.
Measured: Baseline, 3 months, and 6 months
Motivation toward physical activity
Motivation toward physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire (BREQ-2).
Measured: Baseline, 3 months, and 6 months
Patient activation
Patient activation and self-management will be assessed using the Patient Activation Measure (PAM-13).
Measured: Baseline and 6 months
Psychological status assessed using the Depression Anxiety and Stress Scale-21 (DASS-21)
Depression, anxiety, and stress symptoms will be assessed using the 21-item Depression Anxiety and Stress Scale (DASS-21). The questionnaire includes three 7-item subscales assessing depression, anxiety, and stress. Each item is rated from 0 to 3. Raw scores for each subscale range from 0 to 21, with higher scores indicating greater symptom severity.
Measured: Baseline and 6 months
Patient self-management
Patient self-management will be assessed using the Self-Regulation Questionnaire (SRQ).
Measured: Baseline and 6 months.
Perceived stress (PSS)
Perceived stress will be assessed using the Perceived Stress Scale (PSS)
Measured: Baseline, monthly, and 6 months
Perceived stress (VAS-S)
Perceived stress will be assessed using Visual Analogue Scale for Stress (VAS-S). Participant rate perceived stress from 0 (no stress) to 10 (maximum stress). Higher scores indicates greater perceived stress.
Measured: Baseline, weekly, and 6 months
Physiological stress measured using wearable-derived physiological indicators
Physiological stress will be explored using wearable-derived indicators including heart rate variability and other available physiological metrics.
Measured: Continously throughout the 6-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Health InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of the two parallel groups. The intervention group will receive a digital health ecosystem integrating a smartwatch, remote health monitoring, and personalized lifestyle medicine support, in addition to usual primary care. The control group will receive usual primary care alone, supported by the existing electronic health record system.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Space Agency
- Responsible party
- Principal investigator, Caroline Rhéaume, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831837
- Sponsor's protocol ID
- 2025-355
- Acronym
- e-IDEA
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No