NCT01843439

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

4 years

First QC Date

April 26, 2013

Last Update Submit

April 26, 2013

Conditions

AsthmaAged

Keywords

Acute exacerbationQuality of lifeMagnesium deficiencyMultidisciplinary intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Pulmonary function test

    1 year after enrollment

  • Asthma control status

    one year from enrollment

  • asthma quality of life questionnaire

    one year from enrollment

  • serum magnesium level

    one year from enrollment

Study Arms (1)

Intervention

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. 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)

Dietary Supplement: MagnesiumBehavioral: Education for asthma action planBehavioral: hot-lines for acute exacerbation of asthmaBehavioral: Inhaler technique training

Interventions

MagnesiumDIETARY_SUPPLEMENT
Also known as: Product name - Magnes, Composition - Magnesium Lactate 470mg, Pyridoxine HCl 5mg, Company - Daewha pharmaceutical
Intervention
Education for asthma action planBEHAVIORAL
Intervention
hot-lines for acute exacerbation of asthmaBEHAVIORAL
Intervention
Inhaler technique trainingBEHAVIORAL
Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • elderly asthma patients who had experienced acute exacerbation of asthma
  • )aggravations of any of major criteria
  • dyspnea
  • cough
  • wheezing
  • increase or purulent changes of sputum
  • nocturnal symptoms
  • )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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-460, South Korea

Location

MeSH Terms

Conditions

AsthmaMagnesium Deficiency

Interventions

MagnesiumVitamin B 6Educational StatusHotlines

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsPicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSocioeconomic FactorsPopulation CharacteristicsEmergency Medical ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sang-Heon Cho, MD./PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2013

First Posted

April 30, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2016

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

KR(1)