AzTrials
AzTrials

FrailtyFORECASTNCT05509036

Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST) Study Multi-Center Study

An observational study of Frailty and Critical Illness, run by Dr. John Muscedere at 11 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A prospective observational study of critically ill patients over the age of 50, studying the occurrence of frailty as measured by a variety of frailty measures, processes of care and long term outcomes. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Frailty, Critical Illness
How many people
700 participants
Where
11 sitesCanada
Study dates
1 Sep 2019to 1 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Critically ill patients over the age of 50 receiving life support interventions in the Intensive Care Unit

Who may be able to join

  • Must Meet both 1 and 2
  • 1. Age > 50 years. We have selected >50 years in keeping with prior descriptions of critically ill patients [17].
  • 2. Receipt of at least one of the following life support interventions for over 24 hours:
  • Mechanical ventilation: Both invasive and non-invasive either solely or in combination are acceptable. High flow oxygen (e.g. OPTIFLOW) as a form of Non-Invasive Ventilation (NIV) is acceptable but the patient's Fraction of Inspired Oxygen (FIO2) at the time of enrollment must be greater > 50%.
  • Vasoactive medications (vasopressors or inotropes).
  • Acute renal replacement therapy (RRT). Patient must have been admitted to ICU for the receipt of renal replacement therapy, either intermittent or continuous and after 24 hours of ICU admission, there is a continued need for further RRT.

Who cannot join

  • ICU admission greater than 5 days at the time of enrollment.
  • Expected to survive for less than 72 hours after study enrollment.
  • No family or caregivers available to collect collateral history.
  • Family or caregivers not able to speak English or French.
  • Projected inability to complete 6 month follow-up either by telephone or in-person.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Canada11 sites

  • University of Alberta

    Edmonton, Alberta

  • Dalhousie University - QEII

    Halifax, Ontario

  • St Joe's Hamilton

    Hamilton, Ontario

  • Kingston Health Sciences Center

    Kingston, Ontario, K7L2V7

  • Laval University

    Laval, Quebec

  • London Health Sciences Centre

    London, Ontario

  • Hôpital du Sacré-Cœur de Montréal

    Montreal, Quebec

  • Maisonneuve Rosemont

    Montreal, Quebec

  • McGill University

    Montreal, Quebec

  • The Ottawa Hospital

    Ottawa, Ontario

  • Mount Sinai Hospital

    Toronto, Ontario

Other trials in Canada

About this study

Official title: Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST) Multi-Center Study

A prospective observational study of critically ill patients over the age of 50, studying the occurrence of frailty as measured by a variety of frailty measures, processes of care and long term outcomes.

Read the detailed description

Frailty is common in critically ill elderly patients, and is associated with adverse impacts on outcomes and is becoming increasingly common in Intensive Care Unit (ICU) populations. However it is not clear as to how to best measure frailty and when to do so. It is also not clear as to how processes of care impact on the outcomes observed. We hypothesize that frailty in survivors of critical illness will be measurable at hospital discharge, will correlate with processes of care while in ICU and will better discriminate long term outcomes when compared to severity of illness or the degree of frailty present on ICU admission.

Being tested
No interventions
Keywords
Outcomes, Frailty
Medical subject headings
Frailty, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionsOther

    No interventions

Study groups in NCT05509036
Study groupRoleWhat they receive
Critically ill patientsCritically ill adults > 50 admitted to the ICU and receiving a life support intervention
Receives: Other: No interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frailty status

    Frailty as measured with the Clinical Frailty Scale (CFS). CFS is a 9 point scale with frailty defined as a CFS > 4 with higher scores indicating greater degrees of frailty.

    Measured: 6 Months

  2. Frailty status

    Frailty as measured with the Frailty Index (FI). The FI is indicated by the proportion of deficits present over the number measured and is scored as a fraction between 0 and 1.0. Frailty is considered to be present when the FI is > 0.20 and the severity of frailty is considered higher with increasing values for the FI.

    Measured: 6 Months

Secondary outcomes (4)

  1. Number of patients with a measure of frailty prior to hospital discharge.

    Measure of the Frailty Index and Clinical Frailty Scale prior to discharge

    Measured: 28 days

  2. Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life and Need for Institutionalization)

    Clinical outcomes at 6 months will include mortality, Quality of Life (EQ5L) and need for Institutionalization

    Measured: 6 months

  3. Impact of admission critical illness on the development and severity of frailty as measured by a Frailty Index or Clinical Frailty Scale

    Correlation with the progression or presence of frailty as measured with the Frailty Index or Clinical Frailty Scale

    Measured: 28 days and 6 months

  4. Correlation of ICU processes of care (nutritional adequacy, adverse events, mobilization and sedation) with frailty progression as measured by the Clinical Frailty Scale or Frailty Index

    Correlation of processes of care in ICU with frailty progression

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start1 Sep 2019
  3. Primary completion1 Dec 2021
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05509036
Sponsor's protocol ID
FORECAST, V4 - June 7, 2019
Acronym
FORECAST
Status last verified
Sep 2023
First submitted
17 Aug 2022
Last updated
11 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Muscedere J, Bagshaw SM, Kho M, Mehta S, Cook DJ, Boyd JG, Sibley S, Wang HT, Archambault PM, Albert M, Rewa OG, Ball I, Norman PA, Day AG, Hunt M, Loubani O, Mele T, Sarti AJ, Shahin J; Canadian Critical Care Trials Group. Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST): a prospective, multi-centre, cohort study. Intensive Care Med. 2024 Jul;50(7):1064-1074. doi: 10.1007/s00134-024-07404-9. Epub 2024 May 15.

    PubMed 38748266

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Critical Illness, run by Dr. John Muscedere at 11 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frailty status (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05509036, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in