Children Receiving Ventilation at Home for Chronic Illness or DiseaseNCT01863992
The Quality of Life and Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study
An observational study of Children Receiving Ventilation at Home for Chronic Illness or Disease, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Children Receiving Ventilation at Home for Chronic Illness or Disease
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Feb 2015
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children receiving home ventilation for chronic illness or disease
Who may be able to join
- All families, or appointed guardians, caring for children that need home ventilatory support will be eligible for enrollment
Who cannot join
- Refusal to join the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- home ventilation
- Medical subject headings
- Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quality of Life and Direct Financial Costs Associated With Home Ventilation
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.
Measured: One year starting june 2013.
Secondary outcomes (1)
The Quality of Life a Direct Financial Costs Associated With Home Ventilation
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)
Measured: One year starting june 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children Receiving Ventilation at Home for Chronic Illness or DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seear, University of British Columbia
- Investigators
- Mike Seear, MD, Principal investigator, British Columbia's Children's HospitalMike Seear, MD, Principal investigator, BCCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863992
- Sponsor's protocol ID
- H13-00979
- Status last verified
- Sep 2017
- First submitted
- 23 May 2013
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Seear M, Kapur A, Wensley D, Morrison K, Behroozi A. The quality of life of home-ventilated children and their primary caregivers plus the associated social and economic burdens: a prospective study. Arch Dis Child. 2016 Jul;101(7):620-7. doi: 10.1136/archdischild-2015-309796. Epub 2016 Mar 3.
PubMed 26940814
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quality of Life a Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study
- ClinicalTrials.gov ID
- NCT01863992
- Acronym / sponsor ID
- H13-00979
- Keywords
- home ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children receiving home ventilation for chronic illness or disease
Key inclusion criteria (1 listed)
- All families, or appointed guardians, caring for children that need home ventilatory support will be eligible for enrollment
Key exclusion criteria (1 listed)
- Refusal to join the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
The Quality of Life a Direct Financial Costs Associated With Home Ventilation
Time frame: One year starting june 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Derived from this study: PubMed 26940814Seear M, Kapur A, Wensley D, Morrison K, Behroozi A. The quality of life of home-ventilated children and their primary caregivers plus the associated social and economic burdens: a prospective study. Arch Dis Child. 2016 Jul;101(7):620-7. doi: 10.1136/archdischild-2015-309796. Epub 2016 Mar 3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Seear, MD principal investigator
British Columbia's Children's Hospital
Mike Seear, MD principal investigator
BCCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Receiving Ventilation at Home for Chronic Illness or Disease, run by University of British Columbia at 1 site 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 1 inclusion and 1 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 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The Quality of Life and Direct Financial Costs Associated With Home Ventilation (time frame: One year starting june 2013.). 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 NCT01863992, 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 21 Sep 2017.