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

Asthma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01843439
• Other study ID #: H-1205-083-410
• Status: Active, not recruiting
• Phase: N/A
• First received: April 26, 2013
• Last updated: April 26, 2013
• Start date: June 2012

Study information

• Verified date: April 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aged
• Asthma

Intervention

Dietary Supplement:
• Magnesium

Behavioral:
• Education for asthma action plan

• hot-lines for acute exacerbation of asthma

• Inhaler technique training

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Sang-Heon Cho	Korean Center for Disease Control and Prevention

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pulmonary function test	measure when subjects visits the clinic at 3, 6, 12 month after enrollment	1 year after enrollment	No
Secondary	Asthma control status	measure when subjects visit the clinic at 3, 6, 12 month after enrollment	one year from enrollment	No
Secondary	asthma quality of life questionnaire	measure when subjects visit the clinic at 3, 6, 12 month after enrollment	one year from enrollment	No
Secondary	serum magnesium level	measure when subjects visit the clinic at 3, 6, 12 month after enrollment	one year from enrollment	No