HealthyNCT00824486
Home Safety Intervention Using a Safe Home Model
A study testing Injury prevention education (TIPP) and Injury prevention education (safe home) in people with Healthy, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
This project seeks to determine the efficacy of safety education using a safe home model. The 4 X 8 ft. model is designed to look like a house; each of 4 "rooms" has a focused safety message. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Injury prevention education (TIPP) and Injury prevention education (safe home)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Mar 2007
- 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
- Caregivers of children younger than 6 years old
Who cannot join
- Language other than English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hospital
Chicago, Illinois, 60614
About this study
Official title: A Randomized Trial of a Home Safety Intervention Using a Safe Home Model
This project seeks to determine the efficacy of safety education using a safe home model. The 4 X 8 ft. model is designed to look like a house; each of 4 "rooms" has a focused safety message. Families will be enrolled in the clinic and randomized to one of two groups, the safe home model group and the printed safety education materials (TIPP materials) group. The investigators will compare the retention of safety information among caregivers instructed using these two methods. The hypothesis is that families in the safe home model group will have improved retention of safety information.
- Conditions
- Healthy
- Being tested
- Injury prevention education (TIPP), Injury prevention education (safe home)
- Keywords
- child, injury prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injury prevention education (TIPP)Behavioural
using TIPP materials
Injury prevention education (safe home)Behavioural
using safe home model
| Study group | Role | What they receive |
|---|---|---|
| TIPP | Active comparator | Injury prevention education using TIPP materials Receives: Behavioral: Injury prevention education (TIPP) |
| Safe Home Model | Experimental | Injury prevention education using safe home model Receives: Behavioral: Injury prevention education (safe home) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJun 2003
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Single group
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824486
- Sponsor's protocol ID
- 2003-12084
- Status last verified
- Jan 2009
- First submitted
- 15 Jan 2009
- Last updated
- 16 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Home Safety Intervention Using a Safe Home Model
- ClinicalTrials.gov ID
- NCT00824486
- Acronym / sponsor ID
- 2003-12084
- Conditions
- Healthy
- Keywords
- child, injury prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jun 2003
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Jan 2009 (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.
This project seeks to determine the efficacy of safety education using a safe home model. The 4 X 8 ft. model is designed to look like a house; each of 4 "rooms" has a focused safety message. Families will be enrolled in the clinic and randomized to one of two groups, the safe home model group and the printed safety education materials (TIPP materials) group. The investigators will compare the retention of safety information among caregivers instructed using these two methods. The hypothesis is that families in the safe home model group will have improved retention of safety information.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPP | Active comparator | Behavioral: Injury prevention education (TIPP)Injury prevention education using TIPP materials |
| Safe Home Model | Experimental | Behavioral: Injury prevention education (safe home)Injury prevention education using safe home model |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Caregivers of children younger than 6 years old
Key exclusion criteria (1 listed)
- Language other than English or Spanish
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 |
|---|---|---|
| Injury prevention education (TIPP)using TIPP materials | Behavioural | TIPP |
| Injury prevention education (safe home)using safe home model | Behavioural | Safe Home Model |
Primary outcome
Not reported in the source record.
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 Jan 2009.
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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 Injury prevention education (TIPP) and Injury prevention education (safe home) in people with Healthy, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 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 Jan 2009. 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.
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 Jan 2009.