Wounds and InjuriesNCT01845415
Intervention to Prevent Fall Injuries to Young Children in the Home
A study testing Social Marketing Campaign and Intervention components in people with Wounds and Injuries, run by University of Guelph at 1 site in Canada.
Trial summary
Currently, six Public Health Units (PHUs) in Southwestern Ontario are taking part in the developed and implementation of a social marketing intervention campaign aimed at lowering the incidence of falls to children in the home; City of Hamilton - Public Health Services (Control), Durham Public Health… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Social Marketing Campaign and Intervention components
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Oct 2016
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- must be a parent or primary care giver of a child 1 through 4 years of age
- must live in one of the designated communities (by postal code)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community-Based Intervention to Prevent Fall Injuries to Young Children in the Home
Currently, six Public Health Units (PHUs) in Southwestern Ontario are taking part in the developed and implementation of a social marketing intervention campaign aimed at lowering the incidence of falls to children in the home; City of Hamilton - Public Health Services (Control), Durham Public Health, Haldimand-Norfolk Health Unit, Niagara Region Public Health, Wellington-Dufferin-Guelph Public Health and Windsor Public Health (Control). This campaign is based on community-based intervention research and 'best practices' for improving parent attitudes and behaviours toward child safety. The campaign will focus on increasing parents' awareness and knowledge of fall injuries, positively impact parental attitudes to motivate them to want to implement strategies to reduce fall risks, and increase parental safety practices that would counteract the most common mechanisms that contribute to home falls for children at these young ages. The campaign will run from September 2013 through August 2014. The PHUs' social marketing campaign will strategically disseminate different materials to their respective communities: printed materials (posters, pamphlets), video modules about parenting safety, safety information through an e-Health website, and direction communication with parents through Family Health Team practitioners.
The proposed research project will request archival data from Canadian Institute of Health Information (CIHI), specifically from their National Ambulatory Care Reporting System (NACRS), on frequency of falls in the home to determine the extent to which the social marketing campaign is effective. Comparing pre-, during and post-intervention levels in the PHU communities will determine if and which social marketing strategies were effective. Additionally, random digit dialing will be used to assess pre vs post parental fall related attitudes, behaviors and intervention exposure. This evaluation will provide the first ever test of a community level intervention to reduce childhood falls in the home in Canada and will provide valuable information about what constitutes 'best practices' for preventing falls in the home among children 1 through 4 years of age.
- Conditions
- Wounds and Injuries
- Being tested
- Social Marketing Campaign, Intervention components
- 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.
Social Marketing CampaignBehavioural
The campaign will involve distribution of posters throughout the communities promoting awareness of the consequences of fall injuries and encouraging people to go to an website that provides safety information and injury stories.
Intervention componentsBehavioural
Doctors and nurses in these communities will perform health education to parents of 1 through 4 year olds around the risks of falls in the home when these parents visit the doctor for regular visits. Also, several parenting classes in these communities will be modified to include educational videos and discussion of these issues
| Study group | Role | What they receive |
|---|---|---|
| Social Marketting Only | Active comparator | Two communities receive a social marketing campaign to reduce child falls in the home. Receives: Behavioral: Social Marketing Campaign |
| No treatment Control | No intervention | two communities receive no intervention |
| Social Marketing plus Intervention | Active comparator | Two communities receive the social marketing campaign and additional intervention components Receives: Behavioral: Social Marketing Campaign; Behavioral: Intervention components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emergency Department Visits due to Falls in the Home from pre- to post- intervention periods
We will be comparing the rate of injury due to falls in the home during the pre-intervention period with that during the post-intervention period
Measured: One year pre intervention (Oct. 2012- Oct 213), one year post intervention (Oct 2014-Oct 2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara A. Morrongiello, PhD, C. Psych., University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845415
- Sponsor's protocol ID
- 13AP011
- Other IDs
- 450083
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2013
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-Based Intervention to Prevent Fall Injuries to Young Children in the Home
- ClinicalTrials.gov ID
- NCT01845415
- Acronym / sponsor ID
- 13AP011
- Conditions
- Wounds and Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 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.
Currently, six Public Health Units (PHUs) in Southwestern Ontario are taking part in the developed and implementation of a social marketing intervention campaign aimed at lowering the incidence of falls to children in the home; City of Hamilton - Public Health Services (Control), Durham Public Health, Haldimand-Norfolk Health Unit, Niagara Region Public Health, Wellington-Dufferin-Guelph Public Health and Windsor Public Health (Control). This campaign is based on community-based intervention research and 'best practices' for improving parent attitudes and behaviours toward child safety. The campaign will focus on increasing parents' awareness and knowledge of fall injuries, positively impact parental attitudes to motivate them to want to implement strategies to reduce fall risks, and increase parental safety practices that would counteract the most common mechanisms that contribute to home falls for children at these young ages. The campaign will run from September 2013 through August 2014. The PHUs' social marketing campaign will strategically disseminate different materials to their respective communities: printed materials (posters, pamphlets), video modules about parenting safety, safety information through an e-Health website, and direction communication with parents through Family Health Team practitioners.
The proposed research project will request archival data from Canadian Institute of Health Information (CIHI), specifically from their National Ambulatory Care Reporting System (NACRS), on frequency of falls in the home to determine the extent to which the social marketing campaign is effective. Comparing pre-, during and post-intervention levels in the PHU communities will determine if and which social marketing strategies were effective. Additionally, random digit dialing will be used to assess pre vs post parental fall related attitudes, behaviors and intervention exposure. This evaluation will provide the first ever test of a community level intervention to reduce childhood falls in the home in Canada and will provide valuable information about what constitutes 'best practices' for preventing falls in the home among children 1 through 4 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social Marketting Only | Active comparator | Behavioral: Social Marketing CampaignTwo communities receive a social marketing campaign to reduce child falls in the home. |
| No treatment Control | No intervention | –two communities receive no intervention |
| Social Marketing plus Intervention | Active comparator | Behavioral: Social Marketing Campaign, Behavioral: Intervention componentsTwo communities receive the social marketing campaign and additional intervention components |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- must be a parent or primary care giver of a child 1 through 4 years of age
- must live in one of the designated communities (by postal code)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Social Marketing CampaignThe campaign will involve distribution of posters throughout the communities promoting awareness of the consequences of fall injuries and encouraging people to go to an website that provides safety information and injury stories. | Behavioural | Social Marketing plus Intervention, Social Marketting Only |
| Intervention componentsDoctors and nurses in these communities will perform health education to parents of 1 through 4 year olds around the risks of falls in the home when these parents visit the doctor for regular visits. Also, several parenting classes in these communities will be modified to include educational videos and discussion of these issues | Behavioural | Social Marketing plus Intervention |
Primary outcome
Change in Emergency Department Visits due to Falls in the Home from pre- to post- intervention periods
Time frame: One year pre intervention (Oct. 2012- Oct 213), one year post intervention (Oct 2014-Oct 2015)
We will be comparing the rate of injury due to falls in the home during the pre-intervention period with that during the post-intervention period
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 19 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Marketing Campaign and Intervention components in people with Wounds and Injuries, run by University of Guelph 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 2 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 19 Apr 2019. 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?
Change in Emergency Department Visits due to Falls in the Home from pre- to post- intervention periods (time frame: One year pre intervention (Oct. 2012- Oct 213), one year post intervention (Oct 2014-Oct 2015)). 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 19 Apr 2019.