In-patient Asthma Counseling by Pulmonologist and Hospita... | NCT02718339

Studies
In-patient Asthma Counseling by Pulmonologist and Hospital Re-admission Rate

NCT02718339

Sponsor

Soroka University Medical Center

Status

Unknown status

Last Update Posted

Mar 24, 2016Estimated

Enrollment

164Estimated

Phase

Not Applicable

Conditions

Asthma

Interventions

Intensive counseling

Countries

Not provided

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

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Nov 2018Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Mar 20, 2016

First Submission Date that Met QC Criteria

Mar 20, 2016

First Posted Date

Mar 24, 2016Estimated

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

Mar 20, 2016

Last Update Posted Date

Mar 24, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Prospective randomized clinical trial to assess the effect of in-hospital intensive counseling and follow-up vs. usual care, on re-admission rates of patients with Asthma.

The study population will include asthma patients admitted to internal Medicine departments and medical ICU at Soroka University Medical Center, due to asthma exacerbation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

164Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intensive counseling by a pulmonologist	Experimental	Counselor visit during hospitalization, telephone follow up for 4 weeks and a follow up visits.	Behavioral: Intensive counseling
Usual care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intensive counseling	Behavioral		Intensive counseling by a pulmonologist

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Re-admission rate		Within 6 months after discharge

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females ≥ 18 years old.
Admitted to Internal Medicine at Soroka University Medical Center due to asthma exacerbation.

Exclusion Criteria:

Substance abuse (except for tobacco).
Handicapped or bed ridden patients.
Patients who don't speak Hebrew, English, Russian or Arabic.
Other significant respiratory disease such as COPD, interstitial lung disease (as decided by the PI).

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

Name	Role	Phone	Extension	Email
Nimrod Maimon, MD	Contact	972-8-6403417

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