Evaluation and Implementation of Digital Health Ecosystem in Primary Care and Remote Area and Space Exploration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Appropriateness of the digital health ecosystem assessed using the Intervention Appropriateness Measure (IAM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Due to the nature of the intervention, participants, health care providers, and study personnel will not be blinded to group allocation. Participants assigned to the intervention group will receive the digital health ecosystem, including wearable technology and remote health monitoring, in addition to usual primary care, while participants assigned to the control group will receive usual primary care alone supported by the existing electronic health record system.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Integrated Digital Health Ecosystem (Device)
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.
干预措施: Usual Primary Care (Other)
结局指标
主要结局
Appropriateness of the digital health ecosystem assessed using the Intervention Appropriateness Measure (IAM)
时间窗: 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).
Usability of the digital health ecosystem assessed using the System Usability Scale (SUS)
时间窗: 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.
Technology acceptance
时间窗: 6 months
measured using a Technology Acceptance Model (TAM)-based questionnaire
次要结局
- Lifestyle medicine behaviours(Baseline and 6 months)
- Physical activity level(Baseline, 3 months, and 6 months)
- Motivation toward physical activity(Baseline, 3 months, and 6 months)
- Patient activation(Baseline and 6 months)
- Psychological status assessed using the Depression Anxiety and Stress Scale-21 (DASS-21)(Baseline and 6 months)
- Patient self-management(Baseline and 6 months.)
- Perceived stress (PSS)(Baseline, monthly, and 6 months)
- Perceived stress (VAS-S)(Baseline, weekly, and 6 months)
- Physiological stress measured using wearable-derived physiological indicators(Continously throughout the 6-month study period)
研究者
Caroline Rhéaume
Principal investigator, MD, PhD
Laval University