- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02010450
Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives
April 15, 2015 updated by: University of Kansas
Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives: Pilot Testing of the MSSC Physician Safe Sleep Taskforce Caregiver Incentive Toolkit
This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kansas
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Wichita, Kansas, United States, 67214
- KU Wichita Pediatrics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parent of 1-month old baby
- Over the age of 18
- Be able to speak and read English
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wearable Blanket
subjects randomized to this group will receive a wearable blanket (sleep sack) that contains a safe sleep message.
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Active Comparator: Control Group
subjects randomized to this group will receive an incentive item (such as a University of Kansas Pediatrics water Bottle) that does not contain the safe sleep message.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dichotomous sleep variable (safe vs unsafe)
Time Frame: Change from Baseline to 2 Months
|
change measured using "safe sleep quiz" questionnaire
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Change from Baseline to 2 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
determine which incentive item provided is most effective in reinforcing the safe sleep message
Time Frame: Change from Baseline to 2 Months
|
determination to be assessed using questionnaire completed by caregiver
|
Change from Baseline to 2 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carolyn R Ahlers-Schmidt, PhD, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
December 9, 2013
First Posted (Estimate)
December 12, 2013
Study Record Updates
Last Update Posted (Estimate)
April 16, 2015
Last Update Submitted That Met QC Criteria
April 15, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 13-017 (Dana-Farber Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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