The Quality of Life and Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study

September 19, 2017 updated by: Michael Seear, University of British Columbia

The Quality of Life a Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study

The investigators wish to learn about the quality of life (QOL) of children needing long term home ventilation and also that of their regular caregivers. In addition, the investigators will monitor the extra health-related expenses these families must meet. Data will be collected using two age-specific questionnaires of QOL plus a third one validated for assessing chronic health care costs. Questionnaires will be administered at an initial face to face meeting, supplemented by two telephone follow-up calls, to monitor medical expenses, one and two months later.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • BC's Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children receiving home ventilation for chronic illness or disease

Description

Inclusion Criteria:

All families, or appointed guardians, caring for children that need home ventilatory support will be eligible for enrollment

Exclusion Criteria:

Refusal to join the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Quality of Life and Direct Financial Costs Associated With Home Ventilation
Time Frame: One year starting june 2013.
Quality of life for children on home ventilation will be assessed using the validated PedsQL score. This has been specifically designed to measure quality outcome in children with long term health problems.
One year starting june 2013.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Quality of Life a Direct Financial Costs Associated With Home Ventilation
Time Frame: One year starting june 2013
The quality of life for parents caring for a child needing home ventilation will be assessed using a validated questionnaire called the Caregiving Impact Scale (CIS)
One year starting june 2013

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Quality of Life and Direct Financial Costs Associated With Home Ventilation
Time Frame: One year starting june 2013
The out-of-pocket expenses caused by caring for a child with home ventilation will be assessed using a validated questionnaire called the Ambulatory and Home Care Record (AHCR).
One year starting june 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Mike Seear, MD, BCCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Actual)

September 21, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-00979

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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