I-WEAR: Evaluating Wearables and Health Summaries in ICU Survivors

Ludwig Boltzmann Gesellschaft

Status: Enrolling

Conditions: Coronary Artery Disease; Post-Intensive Care Syndrome (PICS); Critical Illness Recovery

Treatments: Behavioral: Digital Health Summary and Lifestyle Counseling; Device: Wearable Health Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07035106

DRP0200543 (Other Grant/Funding Number)

I-WEAR-PICS-1303-2025

Details and patient eligibility

About

This pilot study investigates the use of wearable health technology and bi-weekly digital health summaries in patients recovering from intensive care. Many patients experience physical, psychological, and cognitive challenges after an ICU stay, a condition known as Post-Intensive Care Syndrome (PICS). The study aims to evaluate the feasibility and usability of wearable devices-such as smartwatches, blood pressure monitors, and smart scales-for tracking recovery in real-world settings.

Participants will be randomly assigned to one of three groups: standard ICU follow-up care, wearable use only, or wearable use combined with bi-weekly health reports and optional lifestyle consultations. The study will assess participants' quality of life, experience using the technology, and adherence over a 6-month period. Results will inform the future use of digital tools in post-ICU care.

Full description

I-WEAR is a single-center, non-invasive, randomized feasibility study conducted at the Medical University of Vienna in collaboration with the Ludwig Boltzmann Institute for Digital Health and Patient Safety. The study targets ICU survivors aged 18-65 years with prior ICU stays of ≥48 hours and comorbid diabetes mellitus and/or cardiovascular disease. The goal is to evaluate the feasibility and usability of wearable technologies and digital health reporting to enhance longitudinal care after ICU discharge.

Participants (n=60) are randomized into three groups:

Control group: Standard ICU follow-up care Intervention group 1: Wearables and app (smartwatch, scale, blood pressure monitor) Intervention group 2: Same wearables plus automated bi-weekly health summaries and optional health consultations via Webex Wearable devices include the Garmin Vivosmart 5 (tracking HRV, sleep, stress, and activity), the Garmin Index S2 Smart Scale, and the Garmin Index BPM blood pressure monitor. Data is aggregated via the Fitrockr application and stored in an ISO/IEC 27001-certified cloud environment in compliance with the EU General Data Protection Regulation (GDPR). Participants retain full control over data sharing, and pseudonymized data will be used for research purposes only.

The primary outcomes are feasibility (recruitment, retention, device adherence), and usability (System Usability Scale, qualitative interviews). Secondary outcomes include health-related quality of life measured via SF-36 at enrollment, mid-study (month 3), and study completion (month 6). Descriptive statistics and visualizations will summarize adherence and change trajectories. The study follows CONSORT 2010 guidelines for feasibility studies and includes a decision framework to inform whether to proceed with a definitive trial.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65 years at the time of ICU admission
• ICU stay of at least 48 hours
• ICU discharge within the last 2 years
• Comorbidity of diabetes mellitus and/or chronic heart failure/coronary artery disease
• Written informed consent
• Access to a home internet connection and smartphone with internet and Bluetooth

Exclusion criteria

• Presence of a legal guardian
• No smartphone or internet access
• No cardiovascular disease/event and/or diabetes
• Implanted pacemaker or defibrillator
• Allergies to materials in the wearable devices
• Transfer from an ICU outside the Medical University of Vienna
• Homelessness
• Residence outside of Austria

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Standard care

No Intervention group

Description:

Participants receive standard ICU follow-up care at the Medical University of Vienna without wearable devices or digital health tools.

Wearables Only

Experimental group

Description:

Participants receive wearable health monitoring devices (Garmin Vivosmart 5, Garmin Index S2 Smart Scale, Garmin Index BPM blood pressure monitor) and use the Fitrockr application to visualize and track their data. No counseling or bi-weekly summaries are provided.

Treatment:

Device: Wearable Health Monitoring

Wearables + Summary + Counseling

Experimental group

Description:

Participants receive the same wearable devices and Fitrockr app as the Wearables Only group. In addition, they receive bi-weekly automatically generated health summaries via email and have the option to book lifestyle consultations with a member of the study team via Webex.

Treatment:

Device: Wearable Health Monitoring

Behavioral: Digital Health Summary and Lifestyle Counseling