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

Primary Purpose

Asthma, Aged

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium
Education for asthma action plan
hot-lines for acute exacerbation of asthma
Inhaler technique training
Sponsored by
Sang-Heon Cho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Acute exacerbation, Quality of life, Magnesium deficiency, Multidisciplinary intervention

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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)

Outcomes

Primary Outcome Measures

Number of acute exacerbation of asthma
measure the existence of acute exacerbation when they visit the clinic at 3, 6, 12 month after enrollment

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2013
Last Updated
April 26, 2013
Sponsor
Sang-Heon Cho
Collaborators
Korean Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01843439
Brief Title
Effects of Multidisciplinary Interventions in Elderly Asthma Patients With Risk of Acute Exacerbation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sang-Heon Cho
Collaborators
Korean Center for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Aged
Keywords
Acute exacerbation, Quality of life, Magnesium deficiency, Multidisciplinary intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium
Other Intervention Name(s)
Product name - Magnes, Composition - Magnesium Lactate 470mg, Pyridoxine HCl 5mg, Company - Daewha pharmaceutical
Intervention Type
Behavioral
Intervention Name(s)
Education for asthma action plan
Intervention Type
Behavioral
Intervention Name(s)
hot-lines for acute exacerbation of asthma
Intervention Type
Behavioral
Intervention Name(s)
Inhaler technique training
Primary Outcome Measure Information:
Title
Number of acute exacerbation of asthma
Description
measure the existence of acute exacerbation when they visit the clinic at 3, 6, 12 month after enrollment
Time Frame
1 year from enrollment
Secondary Outcome Measure Information:
Title
Pulmonary function test
Description
measure when subjects visits the clinic at 3, 6, 12 month after enrollment
Time Frame
1 year after enrollment
Title
Asthma control status
Description
measure when subjects visit the clinic at 3, 6, 12 month after enrollment
Time Frame
one year from enrollment
Title
asthma quality of life questionnaire
Description
measure when subjects visit the clinic at 3, 6, 12 month after enrollment
Time Frame
one year from enrollment
Title
serum magnesium level
Description
measure when subjects visit the clinic at 3, 6, 12 month after enrollment
Time Frame
one year from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Heon Cho, MD./PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-460
Country
Korea, Republic of

12. IPD Sharing Statement

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

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