Suspended

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

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What is being tested

Magnesium

+ Education for asthma action plan

+ hot-lines for acute exacerbation of asthma

Dietary SupplementBehavioral
Who is being recruted

Bronchial Diseases+11

+ Deficiency Diseases

+ Hypersensitivity

Over 65 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorSang-Heon Cho
Last updated: April 30, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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. popularize and educate the asthma action plan run a emergency call system for acute exacerbation educate the proper techniques using inhalers 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.

Principal SponsorSang-Heon Cho
Last updated: April 30, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

360 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesDeficiency DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveNutrition DisordersNutritional and Metabolic DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesMalnutritionAsthmaMagnesium Deficiency

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Seoul National University Hospital

Seoul, South KoreaOpen Seoul National University Hospital in Google Maps
SuspendedOne Study Center