NCT03777527

Brief Summary

The PICU-Diary study is a prospective single centre pilot study in the Pediatric Critical Care Unit at McMaster Children's Hospital. We will evaluate the impressions of family caregivers and healthcare providers on the PICU Patient Diary, and its acceptability for use in the PICU, using mixed methods. We will assess the feasibility of assessing the impact of a patient diary on PICU outcomes and psychological distress in critically ill children, 1 month following PICU discharge.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

December 13, 2018

Last Update Submit

February 23, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient Diary Acceptability

    Acceptability of the diary to family members, patients, and healthcare providers in the PICU to determine the perception of impact of the diary on patient recovery. Information collected with surveys and qualitative interviews.

    1 day

  • Feasability of measuring psychological well-being

    Patient reported outcome measure of psychological well-being after critical illness with Children's Critical Illness Impact Scale

    1 day

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients and their families admitted to the PICU at McMaster Children's Hospital

You may qualify if:

  • Consecutive patients admitted to the PICU will be screened for eligibility to participate in the evaluation component of the PICU Diary study
  • We will offer a PICU Diary to families of any critically ill children admitted to the PICU for at least 72 hours and who are fluent in the English language
  • Eligible patients and their families will be approached for consent to participate, by a member of the investigator team (MB, KC, SB or CC). For those who consent to participate, they will be oriented to the diary and its use.

You may not qualify if:

  • Stay less than 72 hours
  • Not fluent in the English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S4K1, Canada

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karen Choong, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 17, 2018

Study Start

October 30, 2019

Primary Completion

December 31, 2020

Study Completion

June 30, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations