Cornell Translational Behavioral Science Research Consort... | NCT00195065

Studies
Cornell Translational Behavioral Science Research Consortium: Asthma Qualitative Study

NCT00195065

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Apr 3, 2008Estimated

Enrollment

Phase

Not provided

Conditions

Asthma

Interventions

Semi-structured, open-ended interviews

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
N01HC25196	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Sep 2003

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2008

Last Update Posted Date

Apr 3, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in asthma patients.

Detailed Description

Through a series of open-ended questions we will explore and build a better understanding of how different patient populations view asthma and the difficulties they face in changing behavior. In addition the responses to such questions should help us to better understand and anticipate some of the barriers and issues that participants may face in successfully changing their behaviors.
The second objective is to use the responses obtained to inform how an intervention of positive affect induction and self-affirmation should be operationalized and tailored.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Semi-structured, open-ended interviews	Behavioral

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients will be eligible for this study if their physicians consider them medically able to participate, if they are 18 years of age or older, and if they have a diagnosis of mild to moderate asthma based on the NHLBI Asthma Expert Panel's classification system which rates symptoms, frequency of exacerbations, nocturnal attacks, activity restriction, use of medications, and pulmonary function.

Exclusion Criteria:

Patients will be excluded from this study for the following reasons:

If they are unable to walk several blocks for whatever reason;
If they have musculoskeletal or neurological deficits that preclude increased physical activity;
If they have other pulmonary diseases;
If they have cardiac disease or other severe comorbidity;
If they are unable to provide informed consent because of cognitive deficits;
If they refuse to participate.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol A Mancuso, MD	Weill Medical College of Cornell University	Principal Investigator
Mary E Charlson, MD	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Presbyterian Hospital-Weill Medical College of Cornell University		New York	New York	10021	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15019010	Background	Mancuso CA, Peterson MG. Different methods to assess quality of life from multiple follow-ups in a longitudinal asthma study. J Clin Epidemiol. 2004 Jan;57(1):45-54. doi: 10.1016/S0895-4356(03)00248-8.
14736086	Background	Mancuso CA, Rincon M, Robbins L, Charlson ME. Patients' expectations of asthma treatment. J Asthma. 2003 Dec;40(8):873-81. doi: 10.1081/jas-120023578.

ID	Term
D001249	Asthma
D009043	Motor Activity
D040242	Risk Reduction Behavior

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases