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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Поведенческое 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.

Первичные конечные точки

• Feasibility and Usability of Wearables in ICU Survivors [Срок оценки: At 6 months after study enrollment]

Вторичные конечные точки (2)

• Change in Health-Related Quality of Life (HRQoL) [Срок оценки: From enrollment (month 0) to study end (month 6)]
• Acceptability of Lifestyle Counseling [Срок оценки: Over 6-month intervention period]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Австрия · 1 центр

• Ludwig Boltzmann Institute Digital Health and Patient Safety — Vienna

Публикации

• Pearson N, Naylor PJ, Ashe MC, Fernandez M, Yoong SL, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020 Oct 31;6(1):167. doi: 10.1186/s40814-020-00634-w. PMID 33292770
• Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664. PMID 34812790
• Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002. PMID 19362699
• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239. PMID 27777223
• Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136. PMID 29562087
• Bayoumy K, Gaber M, Elshafeey A, Mhaimeed O, Dineen EH, Marvel FA, Martin SS, Muse ED, Turakhia MP, Tarakji KG, Elshazly MB. Smart wearable devices in cardiovascular care: where we are and how to move forward. Nat Rev Cardiol. 2021 Aug;18(8):581-599. doi: 10.1038/s41569-021-00522-7. Epub 2021 Mar 4. PMID 33664502
• Duggan MC, Wang L, Wilson JE, Dittus RS, Ely EW, Jackson JC. The relationship between executive dysfunction, depression, and mental health-related quality of life in survivors of critical illness: Results from the BRAIN-ICU investigation. J Crit Care. 2017 Feb;37:72-79. doi: 10.1016/j.jcrc.2016.08.023. Epub 2016 Aug 31. PMID 27652496
• Desai SV, Law TJ, Needham DM. Long-term complications of critical care. Crit Care Med. 2011 Feb;39(2):371-9. doi: 10.1097/CCM.0b013e3181fd66e5. PMID 20959786

Идентификаторы

NCT: NCT07035106 · I-WEAR-PICS-1303-2025 · DRP0200543

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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