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

NCT07035106 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-09

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Wearable Health Monitoring

Participants receive a Garmin Vivosmart 5, Garmin Index S2 Smart Scale, and Garmin Index BPM blood pressure monitor for daily health tracking. Devices sync to the Fitrockr mobile application.

BEHAVIORAL

Digital Health Summary and Lifestyle Counseling

Participants receive bi-weekly health summaries via email generated from wearable data and may opt in to monthly video-based lifestyle consultations with trained study staff.

Sponsors & Collaborators

  • Ludwig Boltzmann Gesellschaft

    lead OTHER

Principal Investigators

  • Harald Willschke, Ao. Univ. Prof. Dr. · Medical University of Vienna / Ludwig Boltzmann Institute for Digital Health and Patient Safety

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-02-28
Completion
2026-05-30

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07035106 on ClinicalTrials.gov