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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02189616
• Other study ID #: xjhx-song2
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2014
• Last updated: August 18, 2014
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2014
• Source: Xijing Hospital
• Contact: Juan Wang, master
• Phone: 18909233806
• Email: ddys1211[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (4)

Lead Sponsor	Collaborator
Xijing Hospital	Baoji Central Hospital, Hanzhong Central Hospital, Yan'an University Affiliated Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cost effectiveness	The cost effectiveness of SMS reminder and consultation interventions compared to controls without study interventions.	3 months	No
Primary	change in asthma control measured by Asthma Control Test(ACT)	change in asthma control measured by Asthma Control Test(ACT) between baseline and 3 months after randomization.	3 months	No
Primary	score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)	score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ) at baseline and 3 months	3 months	No
Secondary	Mini-asthma quality of life questionnaire (mini-AQLQ)	mini-AQLQ scores at baseline and 3 months after the randomization	3 months	No
Secondary	asthma control	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)	3 months	Yes