Heart Defects, CongenitalNCT02831790
The Fontan Education Study: A Randomized Control Trial
A study testing Fontan Education Videos in people with Heart Defects, Congenital, run by University of Alberta at 1 site in Canada.
Trial summary
The Fontan Education Study is a cluster randomized controlled trial evaluating the impact of a novel education program in combination with usual care, versus usual care alone, on preparing parents of children undergoing Fontan surgery for the challenges of the postoperative course. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Fontan Education Videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Aug 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- children who are planned to undergo Fontan surgery within 4-6 weeks and their parent(s)/guardian(s)
Who cannot join
- parents with < grade 6 level of English reading.
Trial locations and contacts
1 site in 1 country.
About this study
The Fontan Education Study is a cluster randomized controlled trial evaluating the impact of a novel education program in combination with usual care, versus usual care alone, on preparing parents of children undergoing Fontan surgery for the challenges of the postoperative course.
- Conditions
- Heart Defects, Congenital
- Being tested
- Fontan Education Videos
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fontan Education VideosOther
The intervention will consist of three brief (~5 minute) professionally-developed whiteboard videos, available online. The videos will feature lay language at a grade 7 level or below and will be engaging. Topics are based on key findings of the Family Resilience Study, namely:
- Stress reactions in children and parents post Fontan. This video will be supplemented with existing resources on the topic.
- Anticoagulation
- Prolonged pleural drainage
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Experimental | Participants in the intervention group will have access to the 3 teaching videos, ~3:30-5:00 minutes in duration each, beginning several weeks prior to the preadmission clinic (as soon as written consent is obtained). Receives: Other: Fontan Education Videos |
| Usual Care | No intervention | Participants in the usual care will not be offered an intervention and will not be made aware of the existence of the teaching videos. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent's State Anxiety Inventory (STAI)-State score preoperatively
The primary endpoint is the parent's STAI-State score within 1 week preceding surgery.
Measured: within 1 week preceding surgery
Secondary outcomes (2)
STAI-State score postoperatively
Parent STAI-State score 1- week and 1-month postoperatively
Measured: 1 week and 1 month postoperatively
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score 1 week and 1 month postoperatively
Measured: 1 week and 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew S Mackie, MD, SM, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831790
- Sponsor's protocol ID
- The Fontan Education Study
- Status last verified
- May 2018
- First submitted
- 11 Jul 2016
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fontan Education Study: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02831790
- Acronym / sponsor ID
- The Fontan Education Study
- Conditions
- Heart Defects, Congenital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 13 Jul 2016 (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 Fontan Education Study is a cluster randomized controlled trial evaluating the impact of a novel education program in combination with usual care, versus usual care alone, on preparing parents of children undergoing Fontan surgery for the challenges of the postoperative course.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Experimental | Other: Fontan Education VideosParticipants in the intervention group will have access to the 3 teaching videos, ~3:30-5:00 minutes in duration each, beginning several weeks prior to the preadmission clinic (as soon as written consent is obtained). |
| Usual Care | No intervention | –Participants in the usual care will not be offered an intervention and will not be made aware of the existence of the teaching videos. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- children who are planned to undergo Fontan surgery within 4-6 weeks and their parent(s)/guardian(s)
Key exclusion criteria (1 listed)
- parents with < grade 6 level of English reading.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fontan Education VideosThe intervention will consist of three brief (~5 minute) professionally-developed whiteboard videos, available online. The videos will feature lay language at a grade 7 level or below and will be engaging. Topics are based on key findings of the Family Resilience Study, namely: 1. Stress reactions in children and parents post Fontan. This video will be supplemented with existing resources on the topic. 2. Anticoagulation 3. Prolonged pleural drainage | Other | Educational Intervention |
Primary outcome
Parent's State Anxiety Inventory (STAI)-State score preoperatively
Time frame: within 1 week preceding surgery
The primary endpoint is the parent's STAI-State score within 1 week preceding surgery.
2 secondary outcomes
STAI-State score postoperatively
Time frame: 1 week and 1 month postoperatively
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Time frame: 1 week and 1 month postoperatively
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 16 Oct 2018.
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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.
Andrew S Mackie, MD, SM principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fontan Education Videos in people with Heart Defects, Congenital, run by University of Alberta 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 16 Oct 2018. 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?
Parent's State Anxiety Inventory (STAI)-State score preoperatively (time frame: within 1 week preceding surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2018.