InjuryFirstAid_2NCT02331121
Multimedia First Aid Program for Families
A study testing Family First Aid Online Training and Text-only Online Training in people with Injury, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
Trial summary
Unintentional injuries are the leading cause of death for children and infants under 14 years of age. Many of these deaths are preventable, in part by promoting injury prevention behaviors but also by administering effective emergency first aid techniques until advanced care arrives. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury
- What is being tested?
- Family First Aid Online Training and Text-only Online Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Feb 2013
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents or guardians of children aged newborn to 12 years old could potentially be as young as 18 years old. Parents or legal guardians could potentially be as old as 65 or older.
- Children under the age of 18 were not included, even with parental consent, because of the online nature of the study and inability to verify parental consoent.
Who cannot join
- Only English-speaking participants were accepted because the program was developed only for English speakers.
- All English-speaking parents of children aged newborn - 12 years old who wished to participate were included.
- There were no exclusions based on race/ethnicity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Center for Applied Science
Eugene, Oregon, 97401
About this study
Unintentional injuries are the leading cause of death for children and infants under 14 years of age. Many of these deaths are preventable, in part by promoting injury prevention behaviors but also by administering effective emergency first aid techniques until advanced care arrives. This project created a web site program that paired video-based instruction with interactive skills training to teach parents of children birth to 12 years old basic first-aid and CPR skills, and that included the option to practice skills as needed.
Read the detailed description
Program content was based on the American Heart Association's (AHA) 2010 guidelines for CPR and first aid training. The Online IMM course was designed to teach participants in six modules: Principles of care; CPR for infants; CPR for children; How to relieve infant choking; How to relieve child choking; and Preventing injuries. Participants were also able to view text articles on first aid topics, such as Wound care or Caring for burns. Although the users of the Online IMM training program did not have direct contact with a manikin during their training, there were opportunities to practice CPR skills through the use of interactive animations. These animations demonstrated and then encouraged users to practice key functions similar to actual CPR skill delivery: including the location, depth and rate of compressions, opening the airway and giving breaths. Participants were encouraged to view the entire program; however, they could navigate and review all program content as much or as little as desired.
- Conditions
- Injury
- Being tested
- Family First Aid Online Training, Text-only Online Training
- Keywords
- children, parents, internet, video, training, interactive
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family First Aid Online TrainingBehavioural
Web-based interactive multimedia program comprised of videos, interactive animations and text information designed to teach parents of children aged birth to 12 years old basic first-aid and CPR skills, including the option to practice skills as needed.
Text-only Online TrainingBehavioural
Online text created from the American Heart Association's 2010 guidelines for CPR training via a computer, depicting infant, child and adult CPR skills and choking relief.
| Study group | Role | What they receive |
|---|---|---|
| Text-only Online Training | Active comparator | Text-only evidence-based training content on CPR, choking relief \& first aid Receives: Behavioral: Text-only Online Training |
| Family First Aid Online Training | Experimental | Interactive multimedia evidence-based training content on CPR, choking relief \& first aid Receives: Behavioral: Family First Aid Online Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge (knowledge score was calculated by summing the number of items answered correctly and dividing by the total number of items to arrive at the percent of items correctly endorsed.)
A knowledge score was calculated by summing the number of items answered correctly and dividing by the total number of items to arrive at the percent of items correctly endorsed.
Measured: 40-day follow-up
Secondary outcomes (1)
Self-efficacy (assessed with a 5-point scale)
Change in self-efficacy to perform CPR and choking relief skills was assessed with a 27- item scale (e.g., How confident are you that you know the correct ratio of compressions to breaths for CPR for a younger child ages 1-8) assessed with a 5-point scale (1=not at all confident; 5=extremely confident; alpha = .97).
Measured: 10-day posttest and 40-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuryStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Center for Applied Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Amelia J Birney, MPH, MCHES, Principal investigator, Oregon Center for Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331121
- Sponsor's protocol ID
- SBIR82RR-II
- Other IDs
- R43HD049156
- Acronym
- FirstAid_2
- Status last verified
- Oct 2016
- First submitted
- 21 Jun 2014
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimedia First Aid Program for Families
- ClinicalTrials.gov ID
- NCT02331121
- Acronym / sponsor ID
- FirstAid_2 / SBIR82RR-II
- Conditions
- Injury
- Keywords
- children, parents, internet, video, training, interactive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Oregon Center for Applied Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 Jan 2015 (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.
Unintentional injuries are the leading cause of death for children and infants under 14 years of age. Many of these deaths are preventable, in part by promoting injury prevention behaviors but also by administering effective emergency first aid techniques until advanced care arrives. This project created a web site program that paired video-based instruction with interactive skills training to teach parents of children birth to 12 years old basic first-aid and CPR skills, and that included the option to practice skills as needed.
Detailed description
Program content was based on the American Heart Association's (AHA) 2010 guidelines for CPR and first aid training. The Online IMM course was designed to teach participants in six modules: Principles of care; CPR for infants; CPR for children; How to relieve infant choking; How to relieve child choking; and Preventing injuries. Participants were also able to view text articles on first aid topics, such as Wound care or Caring for burns. Although the users of the Online IMM training program did not have direct contact with a manikin during their training, there were opportunities to practice CPR skills through the use of interactive animations. These animations demonstrated and then encouraged users to practice key functions similar to actual CPR skill delivery: including the location, depth and rate of compressions, opening the airway and giving breaths. Participants were encouraged to view the entire program; however, they could navigate and review all program content as much or as little as desired.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text-only Online Training | Active comparator | Behavioral: Text-only Online TrainingText-only evidence-based training content on CPR, choking relief \& first aid |
| Family First Aid Online Training | Experimental | Behavioral: Family First Aid Online TrainingInteractive multimedia evidence-based training content on CPR, choking relief \& first aid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parents or guardians of children aged newborn to 12 years old could potentially be as young as 18 years old. Parents or legal guardians could potentially be as old as 65 or older.
- Children under the age of 18 were not included, even with parental consent, because of the online nature of the study and inability to verify parental consoent.
Key exclusion criteria (3 listed)
- Only English-speaking participants were accepted because the program was developed only for English speakers.
- All English-speaking parents of children aged newborn - 12 years old who wished to participate were included.
- There were no exclusions based on race/ethnicity.
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 |
|---|---|---|
| Family First Aid Online TrainingWeb-based interactive multimedia program comprised of videos, interactive animations and text information designed to teach parents of children aged birth to 12 years old basic first-aid and CPR skills, including the option to practice skills as needed. | Behavioural | Family First Aid Online Training |
| Text-only Online TrainingOnline text created from the American Heart Association's 2010 guidelines for CPR training via a computer, depicting infant, child and adult CPR skills and choking relief. | Behavioural | Text-only Online Training |
Primary outcome
Knowledge (knowledge score was calculated by summing the number of items answered correctly and dividing by the total number of items to arrive at the percent of items correctly endorsed.)
Time frame: 40-day follow-up
A knowledge score was calculated by summing the number of items answered correctly and dividing by the total number of items to arrive at the percent of items correctly endorsed.
1 secondary outcome
Self-efficacy (assessed with a 5-point scale)
Time frame: 10-day posttest and 40-day follow-up
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 14 Oct 2016.
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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.
Amelia J Birney, MPH, MCHES principal investigator
Oregon Center for Applied Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family First Aid Online Training and Text-only Online Training in people with Injury, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
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 2 inclusion and 3 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 14 Oct 2016. 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 United States. 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?
Knowledge (knowledge score was calculated by summing the number of items answered correctly and dividing by the total number of items to arrive at the percent of items correctly endorsed.) (time frame: 40-day follow-up). 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 14 Oct 2016.