VPICS: Virtual Care to Improve Post-Intensive Care Syndrome

Sponsor
Hopital Montfort (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05597007
Collaborator
The Ottawa Hospital (Other)
30
2
1
11
15
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: VPICS Clinic
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Virtual Care to Improve Post-Intensive Care Syndrome
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Clinic participation

Behavioral: VPICS Clinic
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Participant satisfaction [Measured at Month 12]

    Measured by the Canadian Health Care Evaluation Project (CANHELP) survey. The validated questionnaire assesses healthcare satisfaction in elderly patients with life-limiting illnesses. This abbreviated 15-item questionnaire contains questions pertaining to trust in healthcare providers, sense of dignity, quality of communication and confidence in planning for future healthcare needs. Each question has 5 options for level of agreement with a given statement (Not at all, not very, somewhat, very, completely).

  2. Participant satisfaction [Measured at Month 12]

    Measured by focus group thematic analysis.

  3. Increased participant quality of life. [Baseline and Month 12]

    Measured by the Functional Independence Measure (FIM). The validated FIM consists of 18 questions and addresses six motor and cognitive functional areas. Each element of the FIM is rated on a scale of 1 to 7, with 7 signifying complete independence.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Ottawa Hospital Ottawa Ontario Canada K1H 8L6
2 Montfort Hospital Ottawa Ontario Canada K1K0T1

Sponsors and Collaborators

  • Hopital Montfort
  • The Ottawa Hospital

Investigators

  • Principal Investigator: Kwadwo Kyeremanteng, MD, Hôpital Montfort

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hopital Montfort
ClinicalTrials.gov Identifier:
NCT05597007
Other Study ID Numbers:
  • 20220547-01H
First Posted:
Oct 27, 2022
Last Update Posted:
Oct 27, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2022