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Clinical Trials/NCT02189616
NCT02189616
Unknown
Not Applicable

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

Xijing Hospital1 site in 1 country360 target enrollmentJuly 2014
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Xijing Hospital
Enrollment
360
Locations
1
Primary Endpoint
score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)
Last Updated
11 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Principal Investigator
Principal Investigator

songlq

vice director of department of respirotary and critical care medine

Xijing Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Inability to provide written informed consent or to fill in the paper asthma diary.
  • A history of smoking cigarettes for greater than ten pack years.
  • Other current or a history of severe comorbidity.
  • Being in other clinical trials.

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

  • asthma control(3 months)
  • Mini-asthma quality of life questionnaire (mini-AQLQ)(3 months)

Study Sites (1)

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