Health TrialsbyHealthPanel

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

ConditionsPost-Intensive Care Syndrome (PICS)Critical Illness RecoveryCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLudwig Boltzmann Gesellschaft

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Presence of a legal guardian

No smartphone or internet access

No cardiovascular disease/event and/or diabetes

Implanted pacemaker or defibrillator

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Standard careNo intervention 0 interventions
Group B: Wearables OnlyExperimental treatment 1 intervention
Group C: Wearables + Summary + CounselingExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
At 6 months after study enrollment

Secondary outcomes

1

Change in Health-Related Quality of Life (HRQoL)

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.

Time frame
From enrollment (month 0) to study end (month 6)
2

Acceptability of Lifestyle Counseling

Number and proportion of participants in intervention group 2 who schedule and attend at least one lifestyle counseling session.

Time frame
Over 6-month intervention period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ludwig Boltzmann Gesellschaft

Lead sponsor

Source ClinicalTrials.gov
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