NCT00512837

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 21, 2016

Status Verified

June 1, 2008

Enrollment Period

1.2 years

First QC Date

August 7, 2007

Last Update Submit

January 20, 2016

Conditions

Asthma

Keywords

Telemedicineclinical managementempowermentengagementeducation

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (1)

  • 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

Study Arms (1)

2

ACTIVE COMPARATOR
Behavioral: Mobile phone technology

Interventions

Mobile phone technologyBEHAVIORAL
2

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with poorly controlled asthma

You may not qualify if:

  • Patient under age of 12
  • Not possessing a mobile phone and who don't have adequate command of the English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Jones and Partner

Norfolk, IP22 4WG, United Kingdom

Location

Related Publications (3)

  • Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

    PMID: 33511633DERIVED

  • Ryan D, Price D, Musgrave SD, Malhotra S, Lee AJ, Ayansina D, Sheikh A, Tarassenko L, Pagliari C, Pinnock H. Clinical and cost effectiveness of mobile phone supported self monitoring of asthma: multicentre randomised controlled trial. BMJ. 2012 Mar 23;344:e1756. doi: 10.1136/bmj.e1756.

    PMID: 22446569DERIVED

  • Ryan D, Pinnock H, Lee AJ, Tarassenko L, Pagliari C, Sheikh A, Price D. The CYMPLA trial. Mobile phone-based structured intervention to achieve asthma control in patients with uncontrolled persistent asthma: a pragmatic randomised controlled trial. Prim Care Respir J. 2009 Dec;18(4):343-5. doi: 10.4104/pcrj.2009.00064. No abstract available.

    PMID: 19940961DERIVED

MeSH Terms

Conditions

AsthmaEmpowerment

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSocial BehaviorBehavior

Study Officials

  • Dermot Ryan

    Univeristy of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 8, 2007

Study Start

November 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 21, 2016

Record last verified: 2008-06

Locations

GB(1)