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临床试验/NCT01843439
NCT01843439Unknown不适用

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

Sang-Heon Cho1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2012年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
360
试验地点
1
主要终点
Number of acute exacerbation of asthma

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •elderly asthma patients who had experienced acute exacerbation of asthma
  • •aggravations of any of major criteria
  • •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

排除标准

  • 未提供

研究组 & 干预措施

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)

干预措施: Education for asthma action plan (Behavioral)

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)

干预措施: hot-lines for acute exacerbation of asthma (Behavioral)

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)

干预措施: Inhaler technique training (Behavioral)

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)

干预措施: Magnesium (Dietary Supplement)

结局指标

主要结局

Number of acute exacerbation of asthma

时间窗: 1 year from enrollment

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

次要结局

  • Asthma control status(one year from enrollment)
  • asthma quality of life questionnaire(one year from enrollment)
  • Pulmonary function test(1 year after enrollment)
  • serum magnesium level(one year from enrollment)

研究者

发起方
Sang-Heon Cho
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sang-Heon Cho

Professor

Seoul National University Hospital

研究点 (1)

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