Evaluation of Decisional Conflict and Needs Assessment in... | NCT01520883

Studies
Evaluation of Decisional Conflict and Needs Assessment in Asthma Management

NCT01520883

Sponsor

Laval University

Status

Completed

Last Update Posted

May 27, 2013Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Canada

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

Status Module

Record Verification Date

May 2013

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

Mar 2011

Primary Completion Date

Apr 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Oct 4, 2011

First Submission Date that Met QC Criteria

Jan 25, 2012

First Posted Date

Jan 30, 2012Estimated

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

May 24, 2013

Last Update Posted Date

May 27, 2013Estimated

Name	Class
CHU de Quebec-Universite Laval	OTHER
AllerGen NCE Inc.	INDUSTRY

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

Many patients suffering from asthma are not compliant to their treatment and consequently, are not well controlled. Shared decision making intervention has shown an improvement in the outcome of patients with chronic disease. The aim of this study is to evaluate decisional conflict and to assess decisional needs of adults with asthma.

Detailed Description

Asthmatic patients will be recruited and asked to fill a decisional conflict scale.

Patients, asthma educators and physicians will also be recruited to fill a needs assessment questionnaire about decisions taken by asthmatics.

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

50Actual

Label	Type	Description	Intervention Names
DEcisional conflict

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measuring Decisional Conflict with a valid Decisional Conflict Scale	To measure the level of decisional conflict, subjects were asked to fill out a decisional conflict scale on asthma management which was developed by O'Connor adapted for our study. This questionnaire consisted of 16 questions. The answers used a Likert scale ranged from 1 - strongly agree to 5 - strongly disagree.	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 years
diagnosed asthma

Exclusion Criteria:

received asthma education in the past 2 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Adults with mild to moderate asthma controlled or slightly controlled

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louis-Philippe Boulet, MD	Institut universitaire de cardiologie et de pneumologie de Quebec	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Universitaire de cardiologie et de pneumologie de Québec		Québec	Quebec	G1V 4G5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided