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Clinical Study on Chinese Children's Asthma Action Plan

Primary Purpose

Asthma in Children

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
asthma action plan management group
conventional management group
Sponsored by
Beijing Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children focused on measuring asthma, children, action plan, China, CCAAP

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • did not receive control treatment or did not reach well-control;
  • can perform spirometry pulmonary function tests;
  • parents are skilled in using smartphones and APP apps (Android or IOS).

Exclusion Criteria:

  • reach the level of asthma control;
  • can not use the smartphone APP software;
  • can not cooperate the test of peak expiratory flow;
  • did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.);
  • combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.).
  • receiving allergen-specific immunotherapy.
  • undergoing trial for other medications or instruments.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    asthma action plan management group

    conventional management group

    Arm Description

    Patients in this group will be provided both written asthma action plan and mobile-based APP to remind them take medicine regularly and direct them what to do when asthma get worse.

    Patients in this group will be provided conventional management method with prescriptions and asthma diaries.

    Outcomes

    Primary Outcome Measures

    number of acute episodes of asthma
    number of acute episodes of asthma in a year

    Secondary Outcome Measures

    the changes of FEV1 before and after management
    the changes of FEV1 before and after management in a year
    the score of children's quality of life
    pediatric asthma quality of life questionnaire contains 23 items in three domains, activity limitation(10), symptoms(5) and emotional function(8). The scale from 1-7 for each question. And the higher score the better quality of life.
    asthma knowledge
    Knowledge, attitude and practice(KAP) questionnaire,contains 27 questions. Multivariate analysis will be carry out based on the answers to questions
    ACT / C-ACT score
    the change of ACT / C-ACT score. there are 5 questions. For each questions, score ranks from 1 to five. Total score 25: well control, 20~24: control, less than 20: un ncontrol
    the absent days of school
    the number of absent days of school because of asthma attack
    the absent days of parents' work
    the number of absent days of parents' work because of children's asthma attack
    the cost of health economics
    the cost of acute asthma exacerbation in a year
    the number of unscheduled medical care
    the number of unscheduled medical care in a year

    Full Information

    First Posted
    February 12, 2018
    Last Updated
    March 16, 2018
    Sponsor
    Beijing Children's Hospital
    Collaborators
    Tian Jing Children's Hospital, Capital Institute of Pediatrics, China, Peking University Third Hospital, Beijing Tsinghua Chang Gung Hospital, Tianjin Medical University Second Hospital, Peking University Bin Hai Hospital, The First Hospital of Qinhuangdao, Tangshan Maternal and Child Health Hospital, Children's Hospital of Hebei Province
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03435822
    Brief Title
    Clinical Study on Chinese Children's Asthma Action Plan
    Official Title
    Clinical Study on Chinese Children's Asthma Action Plan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 22, 2018 (Anticipated)
    Primary Completion Date
    June 30, 2019 (Anticipated)
    Study Completion Date
    June 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Children's Hospital
    Collaborators
    Tian Jing Children's Hospital, Capital Institute of Pediatrics, China, Peking University Third Hospital, Beijing Tsinghua Chang Gung Hospital, Tianjin Medical University Second Hospital, Peking University Bin Hai Hospital, The First Hospital of Qinhuangdao, Tangshan Maternal and Child Health Hospital, Children's Hospital of Hebei Province

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to assess the efficacy of China Children Asthma Action Plan (CCAAP), which is the first asthma action plan for children with asthma in China, in asthma management.
    Detailed Description
    Asthma is the most common chronic illness of childhood. Asthma action plans have been recommended internationally for more than 20 years by the Global Initiative for Asthma and have been shown to improve asthma-related outcomes. The first asthma action plan for children with asthma in China, which is termed China Children Asthma Action Plan(CCAAP), as well as a mobile phone-based asthma self management application(APP), were developed recently. The objective of the study is to assess the efficacy of CCAAP in asthma management. The study is a multi-center prospective case-controlled study.The enrollment period is 3 months. Patients who is in 6-14 years of age will be randomized recruited into two groups: the asthma action plan group and the conventional group. Patients in asthma action plan group will receive written CCAAP and mobile phone-based asthma self-management APP (Youran Respiratory) which includes an electronic asthma action plan, peak expiratory flow monitor system and Peak Expiratory Flow Meter. Patients in conventional management group will write down the symptoms and PEF in asthma diary. The data of the number of asthma episodes, the improvement of FEV1 , the number of unscheduled medical visits, the score of children's quality of life, the questionnaire of asthma knowledge, ACT / C-ACT score, the absent days of parental work, the absent days of children study, and the cost of health economics will be collected regularly in a year with the interval of 3 months to assess the efficacy of CCAAP in asthma management. The study will recruit 200 cases for each group from ten children's hospitals. The study will be completed in a year.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma in Children
    Keywords
    asthma, children, action plan, China, CCAAP

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    asthma action plan management group
    Arm Type
    Other
    Arm Description
    Patients in this group will be provided both written asthma action plan and mobile-based APP to remind them take medicine regularly and direct them what to do when asthma get worse.
    Arm Title
    conventional management group
    Arm Type
    Other
    Arm Description
    Patients in this group will be provided conventional management method with prescriptions and asthma diaries.
    Intervention Type
    Other
    Intervention Name(s)
    asthma action plan management group
    Other Intervention Name(s)
    conventional management group
    Intervention Description
    Patients will follow the directions in asthma action plan when their asthma get worse.
    Intervention Type
    Other
    Intervention Name(s)
    conventional management group
    Intervention Description
    Patients will follow the directions in conventional strategy when their asthma get worse.
    Primary Outcome Measure Information:
    Title
    number of acute episodes of asthma
    Description
    number of acute episodes of asthma in a year
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    the changes of FEV1 before and after management
    Description
    the changes of FEV1 before and after management in a year
    Time Frame
    1 year
    Title
    the score of children's quality of life
    Description
    pediatric asthma quality of life questionnaire contains 23 items in three domains, activity limitation(10), symptoms(5) and emotional function(8). The scale from 1-7 for each question. And the higher score the better quality of life.
    Time Frame
    1 year
    Title
    asthma knowledge
    Description
    Knowledge, attitude and practice(KAP) questionnaire,contains 27 questions. Multivariate analysis will be carry out based on the answers to questions
    Time Frame
    1 year
    Title
    ACT / C-ACT score
    Description
    the change of ACT / C-ACT score. there are 5 questions. For each questions, score ranks from 1 to five. Total score 25: well control, 20~24: control, less than 20: un ncontrol
    Time Frame
    1 year
    Title
    the absent days of school
    Description
    the number of absent days of school because of asthma attack
    Time Frame
    1 year
    Title
    the absent days of parents' work
    Description
    the number of absent days of parents' work because of children's asthma attack
    Time Frame
    1 year
    Title
    the cost of health economics
    Description
    the cost of acute asthma exacerbation in a year
    Time Frame
    1 year
    Title
    the number of unscheduled medical care
    Description
    the number of unscheduled medical care in a year
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: did not receive control treatment or did not reach well-control; can perform spirometry pulmonary function tests; parents are skilled in using smartphones and APP apps (Android or IOS). Exclusion Criteria: reach the level of asthma control; can not use the smartphone APP software; can not cooperate the test of peak expiratory flow; did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.); combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.). receiving allergen-specific immunotherapy. undergoing trial for other medications or instruments.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kunling Shen, MD,PhD
    Phone
    59616666
    Ext
    6308
    Email
    kunlingshen1717@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    kunling Shen, MD,PhD
    Organizational Affiliation
    Beijing Children's Hospital of Capital Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is not a plan to make individual participant available to other researchers so far.

    Learn more about this trial

    Clinical Study on Chinese Children's Asthma Action Plan

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