Mobile Phone Based Structured Intervention
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|ClinicalTrials.gov Identifier: NCT00512837|
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : January 21, 2016
Although asthma outcomes can be improved with structured care, less than half of people with asthma achieve good control. Part of the problem is poor adherence with self-monitoring and preventive drug regimes. This trial will test whether using mobile phone-based monitoring, as part of a structured care plan, improves clinical outcomes and confidence in people with poorly controlled asthma.
Adults and teenagers with poorly controlled asthma will be recruited and randomly assigned to one of two groups. Those in the mobile phone group will monitor their asthma daily using their mobile phone to record symptoms, medication and lung function. Instantaneous feedback to their phone will provide a visual indication of asthma control and prompts about therapy. The patient and their clinician will have web-based access to all readings. People in the control group will use traditional paper-based monitoring. Under the care of their asthma nurse, both groups will be treated according to the step-wise approach of the BTS/SIGN asthma guideline in order to gain control.
We will use the validated Asthma Control Questionnaire to measure control at baseline, three and six months, and compare improvement in the two groups. We will also assess how confident people feel in controlling their asthma, using a validated measure of self-efficacy, attitudes and knowledge.
Technological solutions to long-term healthcare problems are increasingly being sought by patients, clinicians and policy makers. If successful, our trial could provide timely evidence for the use of information technology to address the long-recognised problem of poor asthma control.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: Mobile phone technology||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||A Mobile Phone Based Structured Intervention to Achieve Asthma Control in Patients With Uncontrolled Persistent Asthma: Pragmatic Randomised Controlled Trial|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
|Active Comparator: 2||
Behavioral: Mobile phone technology
- change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference [ Time Frame: 6 months ]
- Morbidity • Mean difference in ACQ at 3 and 6 months.24,36 • Proportion of patients with an ACQ<0.75 at three and six months.27 • Mean difference in mini-AQLQ which measures the physical/emotional impact of asthma on a scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512837
|Dr Jones and Partner|
|Norfolk, United Kingdom, IP22 4WG|
|Principal Investigator:||Dermot Ryan||Univeristy of Aberdeen|