Mobile Phone Based Structured Intervention
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Asthma |
Behavioral: Mobile phone technology |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) 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 |
- 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
| Estimated Enrollment: | 312 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 2 | Behavioral: Mobile phone technology |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient with poorly controlled asthma
Exclusion Criteria:
- Patient under age of 12
- Not possessing a mobile phone and who don't have adequate command of the English language
Contacts and Locations| Contact: Dermot Ryan | 01224 552427 | dermotryan@doctors.org.uk |
| United Kingdom | |
| Dr Jones and Partner | Recruiting |
| Norfolk, United Kingdom, IP22 4WG | |
| Principal Investigator: | Dermot Ryan | Univeristy of Aberdeen |
More Information
No publications provided by University of Aberdeen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dermot Ryan, University of Aberdeen |
| ClinicalTrials.gov Identifier: | NCT00512837 History of Changes |
| Other Study ID Numbers: | 07/047 |
| Study First Received: | August 7, 2007 |
| Last Updated: | June 3, 2008 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Aberdeen:
|
Telemedicine clinical management empowerment engagement education |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013