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

NCT07035106 | Recruiting

• 2 other identifiers: I-WEAR-PICS-1303-2025DRP0200543
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Wearables; Health-related quality of life; ICU survivors; Digital health; Remote patient monitoring; System Usability Scale; SF-36; Bi-weekly health summary; Pilot study; PICS; Cardiovascular disease; Diabetes

Outcome Measures

Primary Outcomes (1)

• Feasibility and Usability of Wearables in ICU Survivors

  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.

  At 6 months after study enrollment

Secondary Outcomes (2)

• Change in Health-Related Quality of Life (HRQoL)

  From enrollment (month 0) to study end (month 6)

• Acceptability of Lifestyle Counseling

  Over 6-month intervention period

Study Arms (3)

Standard care

NO INTERVENTION

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

Wearables Only

EXPERIMENTAL

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.

Device: Wearable Health Monitoring

Wearables + Summary + Counseling

EXPERIMENTAL

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.

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

Interventions

Wearable Health Monitoring DEVICE

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.

Wearables + Summary + Counseling; Wearables Only

Digital Health Summary and Lifestyle Counseling BEHAVIORAL

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.

Wearables + Summary + Counseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig Boltzmann Gesellschaft: lead

Study Sites (1)

Ludwig Boltzmann Institute Digital Health and Patient Safety

Vienna, 1090, Austria

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Jackson JC, Pandharipande PP, Girard TD, Brummel NE, Thompson JL, Hughes CG, Pun BT, Vasilevskis EE, Morandi A, Shintani AK, Hopkins RO, Bernard GR, Dittus RS, Ely EW; Bringing to light the Risk Factors And Incidence of Neuropsychological dysfunction in ICU survivors (BRAIN-ICU) study investigators. Depression, post-traumatic stress disorder, and functional disability in survivors of critical illness in the BRAIN-ICU study: a longitudinal cohort study. Lancet Respir Med. 2014 May;2(5):369-79. doi: 10.1016/S2213-2600(14)70051-7. Epub 2014 Apr 7.

  PMID: 24815803 BACKGROUND

• Ohtake PJ, Lee AC, Scott JC, Hinman RS, Ali NA, Hinkson CR, Needham DM, Shutter L, Smith-Gabai H, Spires MC, Thiele A, Wiencek C, Smith JM. Physical Impairments Associated With Post-Intensive Care Syndrome: Systematic Review Based on the World Health Organization's International Classification of Functioning, Disability and Health Framework. Phys Ther. 2018 Aug 1;98(8):631-645. doi: 10.1093/ptj/pzy059.

  PMID: 29961847 BACKGROUND

• Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.

  PMID: 21946660 BACKGROUND

• Mikkelsen ME, Still M, Anderson BJ, Bienvenu OJ, Brodsky MB, Brummel N, Butcher B, Clay AS, Felt H, Ferrante LE, Haines KJ, Harhay MO, Hope AA, Hopkins RO, Hosey M, Hough CTL, Jackson JC, Johnson A, Khan B, Lone NI, MacTavish P, McPeake J, Montgomery-Yates A, Needham DM, Netzer G, Schorr C, Skidmore B, Stollings JL, Umberger R, Andrews A, Iwashyna TJ, Sevin CM. Society of Critical Care Medicine's International Consensus Conference on Prediction and Identification of Long-Term Impairments After Critical Illness. Crit Care Med. 2020 Nov;48(11):1670-1679. doi: 10.1097/CCM.0000000000004586.

  PMID: 32947467 BACKGROUND

Related Links

• Official study project page of the DIGI4Care - Transforming patient journeys through digital innovation in healthcare across the Danube Region
• Official study project page from the Ludwig Boltzmann Institute for Digital Health and Patient Safety

MeSH Terms

Conditions

postintensive care syndrome; Coronary Artery Disease; Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Harald Willschke, Ao. Univ. Prof. Dr.

  Medical University of Vienna / Ludwig Boltzmann Institute for Digital Health and Patient Safety

  STUDY DIRECTOR

Central Study Contacts

Akos Tiboldi, Dr.med.univ.

CONTACT

+43 660 7432550; akos.tiboldi@lbg.ac.at

Lisa Lichtenegger, BSc MSc

CONTACT

lisa.lichtenegger@lbg.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All participants and staff are aware of the assigned intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized 1:1:1 into standard care, wearable use only, or wearable use with digital health summaries and optional counseling. There is no crossover between groups.

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)