Mobile Phone Based Structured Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Aberdeen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT00512837
First received: August 7, 2007
Last updated: June 3, 2008
Last verified: June 2008
  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

Resource links provided by NLM:


Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512837

Contacts
Contact: Dermot Ryan 01224 552427 dermotryan@doctors.org.uk

Locations
United Kingdom
Dr Jones and Partner Recruiting
Norfolk, United Kingdom, IP22 4WG
Sponsors and Collaborators
University of Aberdeen
Investigators
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 October 19, 2014