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

March 20, 2016 updated by: Soroka University Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive counseling by a pulmonologist
Counselor visit during hospitalization, telephone follow up for 4 weeks and a follow up visits.
Behavioral: Intensive counseling
No Intervention: Usual care

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

March 20, 2016

First Submitted That Met QC Criteria

March 20, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 20, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOR-169-15 CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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