AsthmaNCT02189616
Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on Asthma Control
A study testing SMS reminder, SMS consultation and regular care in people with Asthma, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- SMS reminder, SMS consultation and regular care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
zhikui li, doctor, 13571855922, lizhikui@fmmu.edu.cn
liqiang song, doctor, 13991160546, songlq@fmmu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- SMS reminder, SMS consultation, regular care
- Keywords
- asthma management, SMS reminder, SMS consultation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS reminderBehavioural
send weekly mobile phone short message reminders to the intervention group
SMS consultationOther
told patients to consult qualified asthma nurses by SMS when they need
regular careOther
patients are asked to fill in their paper asthma diary daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| regular care group | Other | receive regular care which contains filling a paper asthma diary daily. Receives: Other: regular care |
| SMS reminder group | Experimental | receive weekly mobile phone short message reminders for 3 months Receives: Behavioral: SMS reminder; Other: regular care |
| SMS reminder and SMS consultation group | Experimental | receive weekly mobile phone short message reminders and can consult asthma nurse by mobile phone short message when needed for 3 months Receives: Behavioral: SMS reminder; Other: SMS consultation; Other: regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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
Measured: 3 months
Secondary outcomes (2)
Mini-asthma quality of life questionnaire (mini-AQLQ)
mini-AQLQ scores at baseline and 3 months after the randomization
Measured: 3 months
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baoji Central Hospital, Hanzhong Central Hospital, Yan'an University Affiliated Hospital
- Responsible party
- Principal investigator, songlq, Xijing Hospital
- Investigators
- liqiang song, doctor, Principal investigator, first affiliated hospital, the fourth military medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189616
- Sponsor's protocol ID
- xjhx-song2
- Status last verified
- Aug 2014
- First submitted
- 24 Mar 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02189616
- Acronym / sponsor ID
- xjhx-song2
- Conditions
- Asthma
- Keywords
- asthma management, SMS reminder, SMS consultation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Baoji Central Hospital, Hanzhong Central Hospital, Yan'an University Affiliated Hospital
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| regular care group | Other | Other: regular carereceive regular care which contains filling a paper asthma diary daily. |
| SMS reminder group | Experimental | Behavioral: SMS reminder, Other: regular carereceive weekly mobile phone short message reminders for 3 months |
| SMS reminder and SMS consultation group | Experimental | Behavioral: SMS reminder, Other: SMS consultation, Other: regular carereceive weekly mobile phone short message reminders and can consult asthma nurse by mobile phone short message when needed for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS remindersend weekly mobile phone short message reminders to the intervention group | Behavioural | SMS reminder and SMS consultation group, SMS reminder group |
| SMS consultationtold patients to consult qualified asthma nurses by SMS when they need | Other | SMS reminder and SMS consultation group |
| regular carepatients are asked to fill in their paper asthma diary daily for 3 months | Other | SMS reminder and SMS consultation group, SMS reminder group, regular care group |
Primary outcome
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.
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
2 secondary outcomes
Mini-asthma quality of life questionnaire (mini-AQLQ)
Time frame: 3 months
asthma control
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
liqiang song, doctor principal investigator
first affiliated hospital, the fourth military medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS reminder, SMS consultation and regular care in people with Asthma, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Wang, master (18909233806, ddys1211@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in asthma control measured by Asthma Control Test(ACT) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2014.