The U.S. National Institutes of Health has an online database called ClinicalTrials.gov that includes a registry of federally and privately supported clinical trials underway or completed. The database currently boasts more than 81,000 clinical trials from some 170 countries. As you might expect a couple dozen of those trials are testing wireless health solutions — mostly mobile phone applications — and their efficacy on health outcomes. MobiHealthNews rounded up 10 mobile phone-equipped clinical trials conducted by numerous academic institutions, world governments and big brand healthcare companies like AstraZeneca.
It is often said that wireless health solutions and healthcare mobile applications will not secure reimbursement or market uptake until they are proven to produce positive health outcomes. In the pages that follow, we have collected the studies underway or completed that are evaluating wireless health. Mine them for partners, processes and applications — and be sure to give us your take on the solutions in these trials — do they represent what’s market ready? Do they point to the future of wireless health?
United Kingdom: A Mobile Phone Based Structured Intervention to Achieve Asthma Control in Patients With Uncontrolled Persistent Asthma: Pragmatic Randomised Controlled Trial
Principal Investigator: Dermot Ryan, University of Aberdeen
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.
Estimated Enrollment: 312
Study Start Date: November 2007
Estimated Study Completion Date: January 2009