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

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.

Study Overview

• Status: Unknown
• Conditions: Asthma; Aged
• Intervention / Treatment: Dietary supplement: Magnesium; Behavioral: Education for asthma action plan; Behavioral: hot-lines for acute exacerbation of asthma; Behavioral: Inhaler technique training

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-460
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.; 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)

Dietary supplement: Magnesium; Other Names: Product name - Magnes; Composition - Magnesium Lactate 470mg, Pyridoxine HCl 5mg; Company - Daewha pharmaceutical; Behavioral: Education for asthma action plan; Behavioral: hot-lines for acute exacerbation of asthma; Behavioral: Inhaler technique training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sang-Heon Cho
• Collaborators: Korean Center for Disease Control and Prevention
• Investigators: Study Chair: Sang-Heon Cho, MD./PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2016
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: April 26, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): April 30, 2013

Study Record Updates

• Last Update Posted (Estimate): April 30, 2013
• Last Update Submitted That Met QC Criteria: April 26, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Quality of life; Acute exacerbation; Magnesium deficiency; Multidisciplinary intervention
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Pyridoxine
• Other Study ID Numbers: H-1205-083-410

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No