NCT02718339

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable asthma

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

March 20, 2016

Last Update Submit

March 20, 2016

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Re-admission rate

    Within 6 months after discharge

Study Arms (2)

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

Intensive counselingBEHAVIORAL
Intensive counseling by a pulmonologist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Nimrod Maimon, MD

CONTACT

972-8-6403417

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2016

First Posted

March 24, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2019

Last Updated

March 24, 2016

Record last verified: 2016-03