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

Not Applicable

• Conditions: Asthma; Aged
• Interventions: Dietary Supplement: Magnesium; Behavioral: Education for asthma action plan; Behavioral: hot-lines for acute exacerbation of asthma; Behavioral: Inhaler technique training

• Registration Number: NCT01843439
• Lead Sponsor: Sang-Heon Cho

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-06
• Status Verified: 2013-04
• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-04-26
• Last Update Submitted: 2013-04-26
• Study First Posted: 2013-04-30
• Last Update Posted: 2013-04-30
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Magnesium	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)
Intervention	Education for asthma action plan	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)
Intervention	hot-lines for acute exacerbation of asthma	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)
Intervention	Inhaler technique training	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)

Primary Outcome Measures

Name	Time	Method
Number of acute exacerbation of asthma	1 year from enrollment	measure the existence of acute exacerbation when they visit the clinic at 3, 6, 12 month after enrollment

Secondary Outcome Measures

Name	Time	Method
Asthma control status	one year from enrollment	measure when subjects visit the clinic at 3, 6, 12 month after enrollment
asthma quality of life questionnaire	one year from enrollment	measure when subjects visit the clinic at 3, 6, 12 month after enrollment
Pulmonary function test	1 year after enrollment	measure when subjects visits the clinic at 3, 6, 12 month after enrollment
serum magnesium level	one year from enrollment	measure when subjects visit the clinic at 3, 6, 12 month after enrollment

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of