Clinical trial NCT02189616: Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on Asthma Control
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: asthma management
SMS reminder
SMS consultation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Baoji Central Hospital
name: Hanzhong Central Hospital
name: Yan'an University Affiliated Hospital
First posted: 2014-07-14
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: change in asthma control measured by Asthma Control Test(ACT)
timeFrame: 3 months
measure: score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)
timeFrame: 3 months
Secondary outcomes:
measure: Mini-asthma quality of life questionnaire (mini-AQLQ)
timeFrame: 3 months
measure: asthma control
timeFrame: 3 months
Other outcomes:
measure: cost effectiveness
timeFrame: 3 months
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: first affiliated hospital, the fourth military medical university
name: liqiang song, doctor
role: PRINCIPAL_INVESTIGATOR
References: