Parents of Asthmatics Quit Smoking - Full Text View

Sponsors and Collaborators:	The Miriam Hospital University of California, Berkeley Brown University
Information provided by:	The Miriam Hospital
ClinicalTrials.gov Identifier:	NCT00862368

Purpose

This study is looking for participants who are a regular smoker and a parent or caregiver. As part of participation they are entitled to receive free, in-home health care for their child delivered by a nurse. If their child has asthma, this treatment will be focused on helping their child breathe better. If their child does not have asthma, this treatment will focus on child safety and wellness. The nurse will talk with them a bit about their smoking, and help them to quit only if they want to. We, the researchers, want to determine whether or not follow-up counseling calls added on to this home treatment are acceptable to NHPRI and BCBSRI members. Participants do not have to quit smoking, or want to quit smoking to be in this study. Once they understand the study, they will be asked if they wish to participate; if so, they will be asked to sign a consent form.

Condition	Intervention	Phase
Asthma Smoking Cessation	Behavioral: Enhanced PAM	Phase III

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Crossover Assignment, Efficacy Study
Official Title:	Sustaining Cessation in Smokers With Kids With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Caregivers Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:

Caregivers quit status [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Child's health status [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	554
Study Start Date:	October 2005
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PAM -Enhanced: Experimental The PAM-Enhanced intervention will receive 2 nurse visits. One visit will be a conversation about their child's asthma. The second visit will discuss the participant's smoking. There are then 6 phone calls that will discuss both the child's asthma and smoking status.	Behavioral: Enhanced PAM This intervention looks at both the teachable moment and the smokers readiness to quit.
PAM: Active Comparator The PAM intervention will receive 2 nurse visits. One visit will be a conversation about their child's asthma. The second visit will discuss the participant's smoking. There are then 6 phone calls that will discuss a child wellness topic.	Behavioral: Enhanced PAM This intervention looks at both the teachable moment and the smokers readiness to quit.
PAM-Healthy: Active Comparator The PAM-Healthy intervention will receive 2 nurse visits. One visit will be a conversation about their child's wellness. The second visit will discuss the participant's smoking. There are then 6 phone calls that will discuss child wellness topics only.	Behavioral: Enhanced PAM This intervention looks at both the teachable moment and the smokers readiness to quit.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Parent/Caregiver of child, >/=18 years of age, Currently smokes 3+ cigarettes/day, Smoked at least 100 cigarettes in lifetime, asthma child has had a hospital visit within 90 days of screen

Exclusion Criteria:

Not a caregiver, Pregnant or lactating, </= 18 years of age, non-smoker, asthma child has not had a hospital visit within 90 days of screen, Using any form of Nicotine replacement therapy, in a quit smoking program, using medications to quit smoking, non-English speaking, illiterate, child has cystic fibrosis, another member of family is participating in program,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862368

Contacts

Contact: Michelle R Landry, MPH	401 793 8044	Mlandry@lifespan.org
Contact: Luis Jusino, BA	401 793 8226	LJusino@lifespan.org

Locations

United States, Massachusetts
St. Anne's Hosptial	Recruiting
Fall River, Massachusetts, United States, 02721
Contact: Daniel R Mahoney 508-674-5600 ext 5514 daniel.mahoney@caritaschristi.org
Sub-Investigator: Jeannine Audet, MD
United States, Rhode Island
The Miriam Hospital	Recruiting
Providence, Rhode Island, United States, 02906
Contact: Michelle R Landry, MPH 401-793-8044 Mlandry@lifespan.org
Contact: Luis Jusino, BA 401 793 8226 LJusino@lifespan.org
Principal Investigator: Belinda Borrelli, PhD

Sponsors and Collaborators

The Miriam Hospital

University of California, Berkeley

Brown University

Investigators

Principal Investigator:

Belinda Borrelli, PhD

Brown University/The Miriam Hospital

More Information

No publications provided

Responsible Party:	The Miriam Hospital/Brown University ( Belinda Borrelli, PhD )
Study ID Numbers:	R01 HL 062165 - PAQS, R01 HL 062165-9
Study First Received:	March 13, 2009
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00862368 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The Miriam Hospital:

Pediatric Asthma
Smoking Cessation
Caregivers
Asthma
Asthma Education
Family Intervention

Smoking
Nicotine Patch
Providence
Rhode Island
Parents

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Nicotine
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Habits
Smoking
Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases

Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009