AsthmaNCT02718339
In-patient Asthma Counseling by Pulmonologist and Hospital Re-admission Rate
A study testing Intensive counseling in people with Asthma, run by Soroka University Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Intensive counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years old.
- Admitted to Internal Medicine at Soroka University Medical Center due to asthma exacerbation.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
Nimrod Maimon, MD contact
About this study
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.
- Conditions
- Asthma
- Being tested
- Intensive counseling
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intensive counseling by a pulmonologist | Experimental | Counselor visit during hospitalization, telephone follow up for 4 weeks and a follow up visits. Receives: Behavioral: Intensive counseling |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-admission rate
Measured: Within 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718339
- Sponsor's protocol ID
- SOR-169-15 CTIL
- Status last verified
- Mar 2016
- First submitted
- 20 Mar 2016
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-patient Asthma Counseling by Pulmonologist and Hospital Re-admission Rate
- ClinicalTrials.gov ID
- NCT02718339
- Acronym / sponsor ID
- SOR-169-15 CTIL
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive counseling by a pulmonologist | Experimental | Behavioral: Intensive counselingCounselor visit during hospitalization, telephone follow up for 4 weeks and a follow up visits. |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females ≥ 18 years old.
- Admitted to Internal Medicine at Soroka University Medical Center due to asthma exacerbation.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive counseling | Behavioural | Intensive counseling by a pulmonologist |
Primary outcome
Re-admission rate
Time frame: Within 6 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nimrod Maimon, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Intensive counseling in people with Asthma, run by Soroka University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nimrod Maimon, MD (972-8-6403417), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-admission rate (time frame: Within 6 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.