Effects of Multidisciplinary Interventions in Elderly Asthma Patients With Risk of Acute Exacerbation

NCT ID: NCT01843439

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Brief Summary

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We want to examine the effect of multidisciplinary interventions in asthma patients who had experienced acute exacerbation of asthma.

In our previous observational studies, elderly asthma patients had a some distinct features such as impairment of cognitive function, deficiency of micronutrient and absence of caregiver compared with young adult asthmatics.

We wanted to evaluate whether the long-term course of asthma could be modified by intervening deficienies which were found in elderly patiensts.

So, we designed a interventional study to correct above risk factors in elderly asthma patients, which could be aggravating their asthma. Followings are our specific multidiciplinary items that we want to correct.

1. popularize and educate the asthma action plan
2. run a emergency call system for acute exacerbation
3. educate the proper techniques using inhalers
4. correct the deficiency of magnesium (magnesium 500 mg per day)

After 1 years, we will measure the numbers of acute exacerbations, lung function including FEV1 and FEV1/FVC, health-related quality of life and level of serum magnesium in study patients.

Detailed Description

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Conditions

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Asthma Aged

Keywords

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Acute exacerbation Quality of life Magnesium deficiency Multidisciplinary intervention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

We designed a intervention study to correct additional risk factors in elderly asthma patients.

We offer following specific interventions simultaneously to intervention arm and will measure the effects of interventions after 1 years.

1. popularize and educate the asthma action plan
2. run a emergency call system for acute exacerbation
3. educate the proper techniques using inhalers
4. correct the deficiency of magnesium (magnesium 500mg per day)

Group Type EXPERIMENTAL

Magnesium

Intervention Type DIETARY_SUPPLEMENT

Education for asthma action plan

Intervention Type BEHAVIORAL

hot-lines for acute exacerbation of asthma

Intervention Type BEHAVIORAL

Inhaler technique training

Intervention Type BEHAVIORAL

Interventions

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Magnesium

Intervention Type DIETARY_SUPPLEMENT

Education for asthma action plan

Intervention Type BEHAVIORAL

hot-lines for acute exacerbation of asthma

Intervention Type BEHAVIORAL

Inhaler technique training

Intervention Type BEHAVIORAL

Other Intervention Names

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Product name - Magnes Composition - Magnesium Lactate 470mg, Pyridoxine HCl 5mg Company - Daewha pharmaceutical

Eligibility Criteria

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Inclusion Criteria

* elderly asthma patients who had experienced acute exacerbation of asthma

1)aggravations of any of major criteria
* dyspnea
* cough
* wheezing
* increase or purulent changes of sputum
* nocturnal symptoms

2)aggravation of more than one of following criteria
* a reduction of forced expiratory volume at one second or peak expiratory flow rate more than 20% compared than one's best score
* unscheduled clinic or emergency department visit or admission
* step-up of dose of asthma medications or any intake of systemic steroids
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korean Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role collaborator

Sang-Heon Cho

OTHER

Sponsor Role lead

Responsible Party

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Sang-Heon Cho

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sang-Heon Cho, MD./PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1205-083-410

Identifier Type: -

Identifier Source: org_study_id