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

August 18, 2014 updated by: songlq, Xijing Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Xiaofan Hu, Bachelor
        • Principal Investigator:
          • liqiang song, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: regular care
patients are asked to fill in their paper asthma diary daily for 3 months
Behavioral: SMS reminder
send weekly mobile phone short message reminders to the intervention group
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
Other: regular care
patients are asked to fill in their paper asthma diary daily 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-asthma quality of life questionnaire (mini-AQLQ)
Time Frame: 3 months
mini-AQLQ scores at baseline and 3 months after the randomization
3 months
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)
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost effectiveness
Time Frame: 3 months
The cost effectiveness of SMS reminder and consultation interventions compared to controls without study interventions.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Baoji Central Hospital
Yan'an University Affiliated Hospital
Hanzhong Central Hospital

Investigators

  • Principal Investigator: liqiang song, doctor, first affiliated hospital, the fourth military medical university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xjhx-song2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on regular care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe