AsthmaNCT00917410
Mobile Phone Text for Optimizing Asthma Treatment
A study testing SMS support in people with Asthma, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The study aims at providing information on how the Short Message Service (SMS) tool influences self-management in asthma patients and to assess the resulting health related effect. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma
- What is being tested?
- SMS support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to May 2008
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- asthmatics
Who cannot join
- below 18 and above 45
- COPD patients
- no mobile phone
- not using the prescribed asthma inhalation medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Health Related Effects of Compliance Optimization in Asthma Through Use of SMS (Short Message System) - A Controlled Trial
The study aims at providing information on how the Short Message Service (SMS) tool influences self-management in asthma patients and to assess the resulting health related effect. A wide range of models and theories exist in the compliance area, such as technical models, communication models, cognitive models and self-management models and theories. The use of some of these theories and models will serve as theoretical and explanatory tools for studying how and why the SMS tool influences the patient's self-management.
Objective:
The objective of this study is to assess the health-related effects of a SMS compliance and monitoring system for optimized asthma treatment in a controlled trial setting.
- Conditions
- Asthma
- Being tested
- SMS support
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS supportBehavioural
The intervention consisted of sequences of SMS messages sent to the intervention group, each containing 2 or 3 monitoring questions and one reminder to take the preventive medication. The SMS sequence was as follows.
- Remember to take your preventive asthma medication (sent at 8.00 am).
- Were you awakened during the night due to your asthma? Answer YES or NO.
- How many times have you taken your asthma attack medication during the last 24 hours? Answer a number.
- What was your peak flow this morning? Answer a number (optional, depending on the participant's use of a spirometer prior to the study).
| Study group | Role | What they receive |
|---|---|---|
| SMS intervention | Experimental | Not described Receives: Behavioral: SMS support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control test
EQ-5D
Measured: 0, 45, 90 days
Use of health services
Measured: 0, 45, 90 days
Use of preventive medicine
Measured: 0, 45, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startNov 2007
- Primary completionMay 2008
- Study completionMay 2008
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- MedicoMonitor Aps, The Ministry of Health and Prevention, Denmark
- Investigators
- Claus Møldrup, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917410
- Sponsor's protocol ID
- UC-SMS-01
- Status last verified
- Jun 2009
- First submitted
- 5 Jun 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Health Related Effects of Compliance Optimization in Asthma Through Use of SMS (Short Message System) - A Controlled Trial
- ClinicalTrials.gov ID
- NCT00917410
- Acronym / sponsor ID
- UC-SMS-01
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- MedicoMonitor Aps, The Ministry of Health and Prevention, Denmark
- Study start
- Nov 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Jun 2009 (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.
The study aims at providing information on how the Short Message Service (SMS) tool influences self-management in asthma patients and to assess the resulting health related effect. A wide range of models and theories exist in the compliance area, such as technical models, communication models, cognitive models and self-management models and theories. The use of some of these theories and models will serve as theoretical and explanatory tools for studying how and why the SMS tool influences the patient's self-management.
Objective:
The objective of this study is to assess the health-related effects of a SMS compliance and monitoring system for optimized asthma treatment in a controlled trial setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMS intervention | Experimental | Behavioral: SMS support |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- asthmatics
Key exclusion criteria (4 listed)
- below 18 and above 45
- COPD patients
- no mobile phone
- not using the prescribed asthma inhalation medication
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 supportThe intervention consisted of sequences of SMS messages sent to the intervention group, each containing 2 or 3 monitoring questions and one reminder to take the preventive medication. The SMS sequence was as follows. 1. Remember to take your preventive asthma medication (sent at 8.00 am). 2. Were you awakened during the night due to your asthma? Answer YES or NO. 3. How many times have you taken your asthma attack medication during the last 24 hours? Answer a number. 4. What was your peak flow this morning? Answer a number (optional, depending on the participant's use of a spirometer prior to the study). | Behavioural | SMS intervention |
Primary outcome
Asthma control test
EQ-5D
Time frame: 0, 45, 90 days
Use of health services
Time frame: 0, 45, 90 days
Use of preventive medicine
Time frame: 0, 45, 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2009.
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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.
Claus Møldrup, PhD principal investigator
University of Copenhagen
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 support in people with Asthma, run by University of Copenhagen at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 10 Jun 2009. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control test. The study lists 4 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 10 Jun 2009.