Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2017-04-17
2018-04-10
Brief Summary
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The aim for Phase I is to develop and integrate school-based interventions to improve asthma self-management and sleep hygiene in urban high school students via interviews.
The aims for Phase II are: (1) to evaluate the feasibility and acceptability of the intervention procedures; and (2) to assess the preliminary evidence of the effects of the intervention on improving sleep quality in urban high school students with persistent asthma over a 2-month follow-up period.
This record is for Phase I only.
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Detailed Description
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To adapt ASMA and Sleep-Smart, the investigators will use a 3-step iterative process that will consist of (1) interviewing high school students and their caregivers, (2) interviewing high school teachers and (3) conducting separate focus groups with students and caregivers. The investigators hypothesize that the intervention will be feasible and acceptable. This study is a multi-site trial and collaboration between Columbia University Medical Center and Rhode Island Hospital (RIH).
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Students: Step 1 Interviews
20 adolescents with uncontrolled asthma and poor sleep \[10 from New York City (NYC); 10 from Rhode Island (RI)\] will provide information regarding their asthma and sleep routines, and on what they would like to see in an intervention targeting co-morbid asthma and poor sleep.
No interventions assigned to this group
Caregivers: Step 1 Interviews
The caregivers of the 20 adolescents in this step \[10 from NYC; 10 from RI\] will be asked to provide information regarding their teenager's asthma and sleep routines, and on what they would like to see in an intervention targeting co-morbid asthma and poor sleep.
No interventions assigned to this group
Teachers: Step 2 Interviews
4 high school teachers, 2 from NYC and 2 from RI, will review the developed intervention. They will provide their opinions about the appropriateness of the teaching methods and literacy level for adolescents.
No interventions assigned to this group
Students: Step 3 Focus Groups
20 adolescents with uncontrolled asthma and poor sleep \[10 from NYC; 10 from RI\] will review the intervention providing feedback on its appropriateness and utility.
No interventions assigned to this group
Caregivers: Step 3 Focus Groups
The caregivers of the 20 adolescents in this step \[10 from NYC; 10 from RI\] will review the intervention providing feedback on its appropriateness and utility in small groups.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. use of prescribed asthma medications;
3. persistent asthma (defined as (i) daytime symptoms 3+ days a week, (ii) night awakenings 3+ nights per month, (iii) 2+ Emergency Department visits or (iv) 1+ hospitalization for asthma); and
4. sleep duration \< 8 hours
\- Teach at the high school level.
Exclusion Criteria
2. A Pediatric Sleep Questionnaire (PSQ) score of 0.33 or more, a well-validated measure of sleep disordered breathing risk;
3. active immunotherapy;
4. additional pulmonary disease; and
5. significant developmental delay and/or severe psychiatric or medical conditions that preclude completion of study procedures or confound analyses.
SCHOOL TEACHERS (4 high school teachers - 2 from New York and 2 from Rhode Island in Step 2)
\- Unwilling to participate in the study.
13 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Columbia University
OTHER
Responsible Party
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Jean-Marie Bruzzese
Professor of Applied Developmental Psychology (in Nursing)
Principal Investigators
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Jean-Marie Bruzzese, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Daphne Koinis-Mitchell, PhD
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital
Locations
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Columbia University
New York, New York, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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References
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Pearce N, Ait-Khaled N, Beasley R, Mallol J, Keil U, Mitchell E, Robertson C; ISAAC Phase Three Study Group. Worldwide trends in the prevalence of asthma symptoms: phase III of the International Study of Asthma and Allergies in Childhood (ISAAC). Thorax. 2007 Sep;62(9):758-66. doi: 10.1136/thx.2006.070169. Epub 2007 May 15.
Akinbami LJ, Schoendorf KC. Trends in childhood asthma: prevalence, health care utilization, and mortality. Pediatrics. 2002 Aug;110(2 Pt 1):315-22. doi: 10.1542/peds.110.2.315.
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Bruzzese JM, Stepney C, Fiorino EK, Bornstein L, Wang J, Petkova E, Evans D. Asthma self-management is sub-optimal in urban Hispanic and African American/black early adolescents with uncontrolled persistent asthma. J Asthma. 2012 Feb;49(1):90-7. doi: 10.3109/02770903.2011.637595. Epub 2011 Dec 7.
Claudio L, Stingone JA, Godbold J. Prevalence of childhood asthma in urban communities: the impact of ethnicity and income. Ann Epidemiol. 2006 May;16(5):332-40. doi: 10.1016/j.annepidem.2005.06.046. Epub 2005 Oct 20.
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Clark NM, Brown R, Joseph CL, Anderson EW, Liu M, Valerio M, Gong M. Issues in identifying asthma and estimating prevalence in an urban school population. J Clin Epidemiol. 2002 Sep;55(9):870-81. doi: 10.1016/s0895-4356(02)00451-1.
Koinis-Mitchell D, McQuaid EL, Kopel SJ, Esteban CA, Ortega AN, Seifer R, Garcia-Coll C, Klein R, Cespedes E, Canino G, Fritz GK. Cultural-related, contextual, and asthma-specific risks associated with asthma morbidity in urban children. J Clin Psychol Med Settings. 2010 Mar;17(1):38-48. doi: 10.1007/s10880-009-9178-3.
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Spilsbury JC, Storfer-Isser A, Kirchner HL, Nelson L, Rosen CL, Drotar D, Redline S. Neighborhood disadvantage as a risk factor for pediatric obstructive sleep apnea. J Pediatr. 2006 Sep;149(3):342-7. doi: 10.1016/j.jpeds.2006.04.061.
Boergers J, Koinis-Mitchell D. Sleep and culture in children with medical conditions. J Pediatr Psychol. 2010 Oct;35(9):915-26. doi: 10.1093/jpepsy/jsq016. Epub 2010 Mar 23.
Koinis-Mitchell D, Kopel SJ, Boergers J, Ramos K, LeBourgeois M, McQuaid EL, Esteban CA, Seifer R, Fritz GK, Klein R. Asthma, allergic rhinitis, and sleep problems in urban children. J Clin Sleep Med. 2015 Jan 15;11(2):101-10. doi: 10.5664/jcsm.4450.
Bruzzese JM, Bonner S, Vincent EJ, Sheares BJ, Mellins RB, Levison MJ, Wiesemann S, Du Y, Zimmerman BJ, Evans D. Asthma education: the adolescent experience. Patient Educ Couns. 2004 Dec;55(3):396-406. doi: 10.1016/j.pec.2003.04.009.
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Wolfson AR, Harkins E, Johnson M, Marco C. Effects of the Young Adolescent Sleep Smart Program on sleep hygiene practices, sleep health efficacy, and behavioral well-being. Sleep Health. 2015 Sep;1(3):197-204. doi: 10.1016/j.sleh.2015.07.002. Epub 2015 Aug 13.
Other Identifiers
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AAAQ9707 - I
Identifier Type: -
Identifier Source: org_study_id
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