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Evaluation and Implementation of Digital Health Ecosystem in Academic Health Center (e-IDEA)

15 settembre 2026 aggiornato da: Caroline Rhéaume, Laval University

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.

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Québec, Canada
        • Caroline Rhéaume
    • Quebec
      • Québec, Quebec, Canada, G1V0A6
        • Université Laval
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Caroline Rhéaume, BSc, MSc, MD, PhD, FCFP
        • Sub-investigatore:
          • Jean-Sébastien Paquet, MD, MSc
        • Sub-investigatore:
          • Raphaëlle Giguère, BSc, MSc
        • Sub-investigatore:
          • Léanie Moreau, MSc
        • Sub-investigatore:
          • Marie-Pierre Gagnon, PhD
        • Sub-investigatore:
          • Maxime Sasseville, PhD
        • Sub-investigatore:
          • Darine Ayemed, PhD
        • Sub-investigatore:
          • Christian Chabot
        • Sub-investigatore:
          • Neila Mezghani, PhD
        • Sub-investigatore:
          • Pierre Cordeau, PhD
        • Sub-investigatore:
          • Alexandre Marois, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Digital Health Ecosystem

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

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.

Comparatore attivo: Usual Primary Care

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.

Participants will receive routine primary care according to standard clinical practice throughout the 6-month study period without access to the digital health ecosystem.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Appropriateness of the digital health ecosystem assessed using the Intervention Appropriateness Measure (IAM)
Lasso di tempo: 6 months

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).

6 months
Usability of the digital health ecosystem assessed using the System Usability Scale (SUS)
Lasso di tempo: 6 months

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.

6 months
Technology acceptance
Lasso di tempo: 6 months

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

6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Lifestyle medicine behaviours
Lasso di tempo: Baseline and 6 months

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).

Baseline and 6 months
Physical activity level
Lasso di tempo: Baseline, 3 months, and 6 months

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

Baseline, 3 months, and 6 months
Motivation toward physical activity
Lasso di tempo: Baseline, 3 months, and 6 months

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

Baseline, 3 months, and 6 months
Patient activation
Lasso di tempo: Baseline and 6 months

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

Baseline and 6 months
Psychological status assessed using the Depression Anxiety and Stress Scale-21 (DASS-21)
Lasso di tempo: Baseline and 6 months

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.

Baseline and 6 months
Patient self-management
Lasso di tempo: Baseline and 6 months.

Patient self-management will be assessed using the Self-Regulation Questionnaire (SRQ).

Baseline and 6 months.
Perceived stress (PSS)
Lasso di tempo: Baseline, monthly, and 6 months

Perceived stress will be assessed using the Perceived Stress Scale (PSS)

Baseline, monthly, and 6 months
Perceived stress (VAS-S)
Lasso di tempo: Baseline, weekly, and 6 months

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.

Baseline, weekly, and 6 months
Physiological stress measured using wearable-derived physiological indicators
Lasso di tempo: Continously throughout the 6-month study period

Physiological stress will be explored using wearable-derived indicators including heart rate variability and other available physiological metrics.

Continously throughout the 6-month study period

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Waist circumference
Lasso di tempo: Baseline and 6 months

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

Baseline and 6 months
Body weight
Lasso di tempo: Baseline and 6 months

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

Baseline and 6 months
Glycated hemoglobin (HbA1c)
Lasso di tempo: Baseline and 6 months

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

Baseline and 6 months
Systolic blood pressure
Lasso di tempo: Baseline and 6 months

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

Baseline and 6 months
Diastolic blood pressure
Lasso di tempo: Baseline and 6 months

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

Baseline and 6 months
Total cholesterol
Lasso di tempo: Baseline and 6 months

Total cholesterol will be measured from blood samples and reported in millimoles per liter (mmol/L).

Baseline and 6 months
Low-density lipoprotein cholesterol (LDL-C)
Lasso di tempo: Baseline and 6 months

High-density lipoprotein cholesterol (HDL-C) will be measured from blood samples and reported in millimoles per liter (mmol/L).

Baseline and 6 months
Triglycerides
Lasso di tempo: Baseline and 6 months

Triglycerides will be measured from blood samples and reported in millimoles per liter (mmol/L).

Baseline and 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 settembre 2026

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

30 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 settembre 2026

Primo Inserito (Effettivo)

21 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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