- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT01713868
Social Media And Risk-reduction Training for Infant Care Practices (SMART) (SMART)
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
FOA PAR-11-242 seeks research that will improve the design, implementation, and effectiveness of interventions to prevent Sudden Infant Death Syndrome (SIDS) and unintentional injury-related infant deaths associated with the sleep environment. The SMART (Social Media and Risk Reduction Training) Infant Care Practices proposal is a collaborative effort among researchers who collectively have generated much of the data on infant care practices that underlie the need for this FOA, and who have access to an already existing and operational infrastructure that permits performance of a large randomized clinical trial to study preventative interventions. This infrastructure was created for the NICHD-funded SAFE Infant Care Practices study, for which mothers are being recruited in 2011, 2012, and 2013 at a nationally-representative group of birth hospitals, with completion of infant care practice surveys at 2-5 months after birth. These hospitals, which will complete their participation in SAFE during 2013, are geographically and culturally diverse, will have had 3 years of baseline infant care practice data collected, and have a proven track record of successful recruitment. We will use our collective extensive experience studying barriers to adherence to safe sleep practices to develop two complementary, culturally competent intervention strategies and to test the effectiveness of each strategy, as well as both strategies in combination. Both of the proposed intervention strategies, described below, were selected largely because they can be used in diverse populations and offer the potential to be rapidly disseminated nationwide.
Nursery Education: A nursery-based training program will be modeled after our successful pilot study and informed by our collective research on barriers to adopting safe sleep practices. We will use social marketing strategies to capture the attention of nursing staff and empower them to improve safe sleep practice modeling and messaging received by mothers and extended families during the post-partum hospital stay.
mHealth: We will use an innovative approach, using mobile messaging, that applies expertise in social marketing to provide multiple short culturally competent videos delivered via email from the end of the post-partum hospital stay through 2 months of age. This strategy will leverage the internet as a powerful tool to access health information, and mobile devices (e.g., cell phones), which have made internet access possible for many, particularly those who are younger, minority, and from lower socioeconomic and educational backgrounds. Using technology to deliver health-related information is likely to be a well-accepted and effective strategy, particularly among minority and low-income populations. Indeed, studies demonstrate that email may be an effective, inexpensive, and time-efficient strategy to transmit health information.
For each of the safe sleep practice interventions (Nursery Education and mHealth), we will develop control interventions in which the Nursery Education or mHealth approach is used to promote breastfeeding. We have chosen breastfeeding as the control intervention because it 1) is not expected to impact endpoints critical to the assessment of the safe sleep practice intervention, and 2) provides health promoting messages to control mothers.
In the SMART study, we propose a 4-arm RCT in which 16 hospitals completing participation in the SAFE study are randomly assigned to one of the following groups (with Safe Sleep Intervention and/or Breastfeeding Control): 1) Safe Sleep Nursery Education and Breastfeeding mHealth messaging; 2) Breastfeeding Nursery Education and Safe Sleep mHealth messaging; 3) Safe Sleep Nursery Education and Safe Sleep mHealth messaging; and 4) Breastfeeding Nursery Education and Breastfeeding mHealth messaging. We are uniquely positioned to design, implement and test the effectiveness of these interventions in a methodologically rigorous way and propose the following specific aims: Primary Aim: To assess the effectiveness of the interventions aimed at promoting safe sleep practices compared with the breastfeeding controls.
Hypothesis:For each recommended safe sleep practice (supine sleep position, not bed sharing, pacifier use, avoiding use of soft bedding), when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging.
Secondary Aim: Assess potential mediating factors that may explain the intervention effects on infant care practices and that may inform areas for future improved intervention approaches.
Hypothesis: Changes in variables within each of the domains of the Theory of Planned Behavior (Attitudes/Beliefs, Social Norms, Perceived Control) will be mediators of the effectiveness of safe sleep interventions.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- mothers must live in the US, deliver a healthy infant in one of the study hospitals, plan to take her baby home with her, and be able to receive emails.
Exclusion Criteria:
- mothers who are not English speaking, whose infant is deceased, those not having custody of the infant, and those whose infants require hospitalization for more than 1 week, or have an ongoing medical problem requiring subspecialty care and mothers who are unable to receive email messages.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Tényező hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Egyéb: Safe Sleep Edu and Breastfeeding mHealth
Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging
|
Nursery-based program for safe sleep
Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
|
Egyéb: Breastfeeding Edu and Safe Sleep mHealth
Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging
|
Nursery-based program to promote breastfeeding
Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.
|
Egyéb: Safe Sleep Edu and Safe Sleep mHealth
Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging
|
Nursery-based program for safe sleep
Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.
|
Egyéb: Breastfeed Edu and Breastfeed mHealth
Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging
|
Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
Nursery-based program to promote breastfeeding
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Adherence With Recommended Supine Sleep Position
Időkeret: 6 months
|
Hypothesis:For supine sleep position, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging.
Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
|
6 months
|
Adherence With Recommended Roomsharing Without Bed Sharing
Időkeret: 6 months
|
Hypothesis: For roomsharing without bed sharing, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging.
Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
|
6 months
|
Adherence With Recommended Pacifier Use
Időkeret: 6 months
|
Hypothesis: For pacifier use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging.
Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
|
6 months
|
Adherence With Recommended Avoiding Use of Soft Bedding
Időkeret: 6 months
|
Hypothesis: For each recommended avoidance of soft bedding use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging.
Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
|
6 months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep
Időkeret: 6 months
|
Questions assessing attitudes toward sleep position included the mothers' ratings regarding if she believed that each infant sleep position (back, side, stomach) made the baby healthy, safer, more comfortable, and kept the baby from choking.
Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both supine and side sleep would lead to a categorization of not having positive attitudes towards supine sleep only).
|
6 months
|
Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.
Időkeret: 6 months
|
Questions assessing attitudes toward sleep location (bedsharing, roomsharing without bedsharing) assessed whether the location was pleasant for the baby and/or mother, safer for the baby, more comfortable for the baby and/or mother, and kept the baby from choking.
Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both bedsharing and not bedsharing would lead to a categorization of not having positive attitudes towards bedsharing only).
|
6 months
|
Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep
Időkeret: 6 months
|
Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location.
Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors.
|
6 months
|
Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.
Időkeret: 6 months
|
Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location.
Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors
|
6 months
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Michael Corwin, MD, Boston University
- Kutatásvezető: Eve R Colson, M.D., Yale University
- Kutatásvezető: Fern R Hauck, M.D., M.S., University of Virginia
- Kutatásvezető: Rachel Moon, MD, University of Virginia
Publikációk és hasznos linkek
Általános kiadványok
- Moon RY, Corwin MJ, Kerr S, Heeren T, Colson E, Kellams A, Geller NL, Drake E, Tanabe K, Hauck FR. Mediators of Improved Adherence to Infant Safe Sleep Using a Mobile Health Intervention. Pediatrics. 2019 May;143(5):e20182799. doi: 10.1542/peds.2018-2799.
- Moon RY, Hauck FR, Colson ER, Kellams AL, Geller NL, Heeren T, Kerr SM, Drake EE, Tanabe K, McClain M, Corwin MJ. The Effect of Nursing Quality Improvement and Mobile Health Interventions on Infant Sleep Practices: A Randomized Clinical Trial. JAMA. 2017 Jul 25;318(4):351-359. doi: 10.1001/jama.2017.8982.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- 1R01HD072815-01 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Kockázatcsökkentési
-
Centre Hospitalier Universitaire de NīmesBefejezveSclerosis multiplex | Radiológiailag izolált szindróma (RIS)Franciaország