Clinical trial NCT05597007: Virtual Care to Improve Post-Intensive Care Syndrome
Official title: Virtual Care to Improve Post-Intensive Care Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Intensive Care Syndrome
Lead sponsor: Hopital Montfort
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
First posted: 2022-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Creation of a feasible virtual model of PICS care.
timeFrame: Measured at Month 12
Secondary outcomes:
measure: Participant satisfaction
timeFrame: Measured at Month 12
measure: Participant satisfaction
timeFrame: Measured at Month 12
measure: Increased participant quality of life.
timeFrame: Baseline and Month 12
measure: Increased participant quality of life.
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Montfort Hospital
state: Ontario
Study officials:
affiliation: Hôpital Montfort
name: Kwadwo Kyeremanteng, MD
role: PRINCIPAL_INVESTIGATOR
References: