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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07035106
• Lead Sponsor: Ludwig Boltzmann Gesellschaft

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-05-24
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Study Start: 2025-07-01
• Primary Completion: 2026-02-28
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility and Usability of Wearables in ICU Survivors	At 6 months after study enrollment	Feasibility will be assessed by recruitment rate, retention rate, and adherence to wearable device use. Usability will be assessed using the System Usability Scale (SUS) at the end of the study.

Secondary Outcome Measures

Name	Time	Method
Change in Health-Related Quality of Life (HRQoL)	From enrollment (month 0) to study end (month 6)	Measured using the SF-36 Version 2 questionnaire at baseline, mid-point (3 months), and end of study (6 months). Group-level and within-subject changes will be analyzed.
Acceptability of Lifestyle Counseling	Over 6-month intervention period	Number and proportion of participants in intervention group 2 who schedule and attend at least one lifestyle counseling session.