Virtual Care to Improve Post-Intensive Care Syndrome

Not Applicable

Not yet recruiting

• Conditions: Post Intensive Care Syndrome
• Interventions: Behavioral: VPICS Clinic

• Registration Number: NCT05597007
• Lead Sponsor: Hopital Montfort

Brief Summary

The goal of this interventional trial is to learn about whether a virtual clinic can help patients with post-intensive care unit syndrome regain functional ability. Participants will participate in a 12-month online clinic where they will receive physiotherapy, nutritional planning, mental health support and cognitive strengthening. Functional capacity will be measured throughout the clinic. After, they will be asked questions about their clinic experience, and complete a questionnaire.

Detailed Description

Virtual Care to Improve Post-Intensive Care Syndrome (V-PICS) is a multidisciplinary virtual clinic designed to address the three components of post-intensive care syndrome (PICS): physical impairment, cognitive decline and mental health challenges. This initiative targets ICU survivors who received mechanical ventilation for a minimum of 48 hours. Referred patients will access live sessions with healthcare professionals who will guide at-home strategies to address PICS including physiotherapy, nutritional planning, mental health support and cognitive strengthening. The clinic will provide an integrated approach to addressing the challenges faced by ICU survivors. The feasibility of this virtual clinic will be assessed by measuring patient satisfaction, clinic effectiveness and levels of engagement and attendance. The study's findings will inform the creation of a robust multi-centre clinical trial that will contribute to the creation of a national standard of PICS care and increase health system efficiencies.

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Study Start: 2024-05
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• over 18 years of age
• received mechanical ventilation for a minimum of 48 hours in the ICU
• discharged from the hospital in the 2 months prior to study start

Exclusion Criteria

• Individuals originating from an assisted living/ long-term care facility
• lack a capacity for informed consent
• have end-stage illnesses
• present a significant fall risk
• cannot speak English or French
• do not have the technological skills or caregiver support to ensure digital literacy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	VPICS Clinic	Clinic participation

Primary Outcome Measures

Name	Time	Method
Creation of a feasible virtual model of PICS care.	Measured at Month 12	Measured by participant focus groups concerning participation, attrition, adherence, engagement, perceived value.

Secondary Outcome Measures

Name	Time	Method
Participant satisfaction	Measured at Month 12	Measured by focus group thematic analysis.
Increased participant quality of life.	Baseline and Month 12	Measured by the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS examines physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles and activities, pain interference/intensity. The PROMIS-29 questionnaire has 29 questions rated on scales of 1 to 5 or 1 to 10.

Trial Locations

Locations (2)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Montfort Hospital; 🇨🇦 Ottawa, Ontario, Canada