NCT05597007

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

October 25, 2022

Last Update Submit

December 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Creation of a feasible virtual model of PICS care.

    Measured by participant focus groups concerning participation, attrition, adherence, engagement, perceived value.

    Measured at Month 12

Secondary Outcomes (4)

  • Participant satisfaction

    Measured at Month 12

  • Participant satisfaction

    Measured at Month 12

  • Increased participant quality of life.

    Baseline and Month 12

  • Increased participant quality of life.

    Baseline and Month 12

Study Arms (1)

Treatment

EXPERIMENTAL

Clinic participation

Behavioral: VPICS Clinic

Interventions

VPICS ClinicBEHAVIORAL

Participants will complete a mix of mandatory synchronous and asynchronous sessions with their Health Group to address PICS. Participants will spend 15 minutes daily on physiotherapy, and 15 minutes on cognitive therapy. There are also 2h time slots everyday for participants to join for an optional check-in with their health coach, who can support them in their individual activities. Participants will spend 15 minutes weekly responding to journal prompts about nutrition and general challenges.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Montfort Hospital

Ottawa, Ontario, K1K0T1, Canada

Location

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

  • Kwadwo Kyeremanteng, MD

    Hôpital Montfort

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwadwo Kyeremanteng, MD

CONTACT

Julia Hajjar, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 27, 2022

Study Start

May 1, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations