Wearables and digital health summaries to support ICU survivors' recovery
I-WEAR: From ICU to Recovery - Evaluating the Feasibility and Usability of Bi-Weekly Health Summaries Using Wearables in Patients After Intensive Care Unit Treatment - A Pilot Study
This pilot will test whether wearable devices plus optional twice-monthly digital health summaries help adults 18–65 recover after an ICU stay, focusing on people with diabetes or coronary artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ludwig Boltzmann Gesellschaft Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT07035106 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized feasibility pilot in Vienna will enroll 60 ICU survivors and assign them to standard follow-up, wearables only, or wearables plus bi-weekly health summaries and optional lifestyle consultations. Participants use a smartwatch, smart scale, and blood pressure monitor with data aggregated via a secure cloud app, and they are followed for six months. Primary outcomes are feasibility (recruitment, retention, device adherence) and usability (System Usability Scale and interviews), with secondary outcomes including health-related quality of life. Results will inform whether larger trials of remote monitoring and digital summaries are worthwhile for post-ICU care.
Who should consider this trial
Good fit: Ideal candidates are ICU survivors aged 18–65 who had an ICU stay of at least 48 hours, have diabetes and/or coronary artery disease, live in Austria, and have a smartphone and home internet.
Not a fit: Patients without smartphone or internet access, those living outside Austria, those without the specified comorbidities, or those with implanted pacemakers/defibrillators are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of recovery problems and more personalized follow-up, potentially improving quality of life after ICU discharge.
How similar studies have performed: Remote monitoring and wearable-based programs have shown promise in chronic cardiac and diabetes care, but using wearables specifically for post-ICU recovery is relatively novel with limited prior trial data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vienna
- Ludwig Boltzmann Institute Digital Health and Patient Safety — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Akos Tiboldi, Dr.med.univ.
- Email: akos.tiboldi@lbg.ac.at
- Phone: +43 660 7432550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.