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Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on Asthma Control

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ClinicalTrials.gov Identifier: NCT02189616
Recruitment Status : Unknown
Verified August 2014 by songlq, Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : July 14, 2014
Last Update Posted : August 19, 2014
Sponsor:
Collaborators:
Baoji Central Hospital
Hanzhong Central Hospital
Yan'an University Affiliated Hospital
Information provided by (Responsible Party):
songlq, Xijing Hospital

Study Description
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Brief Summary:

Asthma is the disease being studied. The main objective of this study is to assess the clinical efficacy of mobile phone short message service (SMS) reminder and consultation on the self-management and outcomes of poorly controlled asthma which is first diagnosed in a time period of 3 months. The secondary objective is to explore the cost-benefit and cost-effectiveness of the proposed intervention.

Aims: The main aim of this study is to assist asthma patients to practice asthma self-management at home by sending reminders and responding to patients' consultations with mobile phone short message service (SMS), which will eventually help them to control their asthma, and prevent asthma exacerbation. Thus, the ultimate goal of this proposed study is to improve patient health outcome via enhancing patient-physician interaction through mobile phone short message service (SMS) that is low-cost and could be followed easily by the patients and their physicians.

The hypothesis is that asthma patients who receive weekly text message reminders to educate them and reinforce adherence will have better asthma outcome, such as asthma control, while the intervention integrating patient consultation and reminders by SMS improve asthma outcome even more. The investigators further hypothesize that these subjects under intervention will have an improvement in secondary measures including quality of life and patient satisfaction. The investigators also anticipate that such an approach in asthma management will be cost-effective.


Condition or disease Intervention/treatment Phase
Asthma Behavioral: SMS reminder Other: SMS consultation Other: regular care Not Applicable

Detailed Description:
After examined for their eligibility and recruited into this study at outpatient service, all participants have their case records which contain their baseline data and receive the same standard asthma education(including basic knowledge about asthma, how to use their medicine, what to do when an asthma attack happens and when to come back for their disease review and so on). Each patient is given a paper asthma diary and a peak expiratory flow(PEF) measurer for free. In addition, they are told what intervention they will receive and revised face-to-face one month after the beginning of intervention. After the 3-month study period, when they return to the hospitals, they will return the asthma diaries, be asked to fill in the questionnaires and take pulmonary function tests.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluate the Clinical Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on the Self-management and Outcomes of Poorly-controlled Asthma: a Multicenter Randomized Controlled Trial
Study Start Date : July 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
regular care group
receive regular care which contains filling a paper asthma diary daily.
 Other: regular care
patients are asked to fill in their paper asthma diary daily for 3 months
Experimental: SMS reminder group
receive weekly mobile phone short message reminders for 3 months
 Behavioral: SMS reminder
send weekly mobile phone short message reminders to the intervention group

Other: regular care
patients are asked to fill in their paper asthma diary daily for 3 months
Experimental: SMS reminder and SMS consultation group
receive weekly mobile phone short message reminders and can consult asthma nurse by mobile phone short message when needed for 3 months
 Behavioral: SMS reminder
send weekly mobile phone short message reminders to the intervention group

Other: SMS consultation
told patients to consult qualified asthma nurses by SMS when they need

Other: regular care
patients are asked to fill in their paper asthma diary daily for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. change in asthma control measured by Asthma Control Test(ACT) [ Time Frame: 3 months ]
    change in asthma control measured by Asthma Control Test(ACT) between baseline and 3 months after randomization.

  2. score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ) [ Time Frame: 3 months ]
    score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ) at baseline and 3 months


Secondary Outcome Measures :
  1. Mini-asthma quality of life questionnaire (mini-AQLQ) [ Time Frame: 3 months ]
    mini-AQLQ scores at baseline and 3 months after the randomization

  2. asthma control [ Time Frame: 3 months ]
    change of asthma control level indicated by symptom score, PEF and asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing) from baseline to the end of intervention(3 months)


Other Outcome Measures:
  1. cost effectiveness [ Time Frame: 3 months ]
    The cost effectiveness of SMS reminder and consultation interventions compared to controls without study interventions.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Physician diagnosed uncontrolled or partly-controlled asthma by Global Initiative for Asthma(GINA) standard.
  2. At least 6 months asthma history.
  3. Ownership of a mobile phone and currently using the text messaging service.
  4. Age between 18 and 65 years old.
  5. Willingness to participate in this study.
  6. Willing to sign the written informed consent to take part in the study.

Exclusion Criteria:

  1. Inability to provide written informed consent or to fill in the paper asthma diary.
  2. A history of smoking cigarettes for greater than ten pack years.
  3. Other current or a history of severe comorbidity.
  4. Being in other clinical trials.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189616


Contacts
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Contact: Juan Wang, master 18909233806 ddys1211@163.com

Locations
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China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: zhikui li, doctor    13571855922    lizhikui@fmmu.edu.cn   
Contact: liqiang song, doctor    13991160546    songlq@fmmu.edu.cn   
Sub-Investigator: Xiaofan Hu, Bachelor         
Principal Investigator: liqiang song, doctor         
Sponsors and Collaborators
Xijing Hospital
Baoji Central Hospital
Hanzhong Central Hospital
Yan'an University Affiliated Hospital
Investigators
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Principal Investigator: liqiang song, doctor first affiliated hospital, the fourth military medical university
More Information
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Responsible Party: songlq, vice director of department of respirotary and critical care medine, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02189616    
Other Study ID Numbers: xjhx-song2
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Keywords provided by songlq, Xijing Hospital:
asthma management
SMS reminder
SMS consultation
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases