Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Apr 21;8(4):e021136.
doi: 10.1136/bmjopen-2017-021136.

A smartphone application for reporting symptoms in adults with cystic fibrosis: protocol of a randomised controlled trial

Jamie Wood  1   2   3 , Sue Jenkins  1   2   3 , David Putrino  4   5 , Siobhain Mulrennan  3   6 , Sue Morey  3   6 , Nola Cecins  2 , Kylie Hill  1   3
Affiliations

A smartphone application for reporting symptoms in adults with cystic fibrosis: protocol of a randomised controlled trial

Jamie Wood et al. BMJ Open. .

Abstract

Introduction: In people with cystic fibrosis (CF), exacerbations have been shown to have profound and prolonged negative effects such as reducing physical activity and health-related quality of life, increasing the rate of decline of lung function and healthcare costs, and ultimately increasing the risk of mortality. Delayed initiation of treatment following the signs of an exacerbation has been shown to be associated with failure to recover to baseline. Therefore, the late identification and treatment of an exacerbation due to delayed presentation will potentially worsen short-term and long-term outcomes. We have developed a smartphone application, containing questions which require yes or no responses relating to symptoms suggestive of a respiratory exacerbation. Its use is intended to facilitate the early identification of symptoms suggestive of a respiratory exacerbation, and allow the CF team to initiate treatment sooner, thereby potentially reducing the risk of severe exacerbations which require intravenous antibiotics (IVAB) and often a hospital admission.

Methods: We will undertake a randomised controlled trial. 60 adults with CF will be recruited and randomised to either the intervention or control group. The intervention group will use the smartphone application weekly for 12 months, or earlier than the next weekly reporting time if they feel their symptoms have worsened. The control group will continue to receive usual care, involving regular (approximately 3 monthly) CF outpatient clinic appointments. The primary outcome measure will be courses and days of IVAB.

Ethics and dissemination: Approval was obtained from the Sir Charles Gairdner Group Human Research Ethics Committee for WA Health (2015-030) and Curtin University Human Research Ethics Committee (HR212/2015), and has been registered with the Australian and New Zealand Clinical Trials Registry. Results of this study will be presented at international conferences and published in peer-reviewed journals in accordance with the Consolidated Standards of Reporting Trials statement.

Trial registration number: ACTRN12615000599572.

Keywords: cystic fibrosis; exacerbations; smartphone; telehealth; telemedicine.

PubMed Disclaimer

Conflict of interest statement

Competing interests: JW reports grants from Sir Charles Gairdner Group Research Advisory Council, during the conduct of the study, grants from Technipro Pulmomed, non-financial support from Novartis, non-financial support from Pharmaxis, outside the submitted work. SJ reports grants from Sir Charles Gairdner Group Research Advisory Council, during the conduct of the study. SMu reports grants from Sir Charles Gairdner Group Research Advisory Council, during the conduct of the study, personal fees from Vertex, non-financial support from Novartis, outside the submitted work.

Figures

Figure 1
Figure 1
‘Study design’. CF, cystic fibrosis.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Ward N, White D, Rowe H, et al. . Physical activity levels of patients with cystic fibrosis hospitalised with an acute respiratory exacerbation. Respir Med 2013;107:1014–20. 10.1016/j.rmed.2013.03.002 - DOI - PubMed
    1. Britto MT, Kotagal UR, Hornung RW, et al. . Impact of recent pulmonary exacerbations on quality of life in patients with cystic fibrosis. Chest 2002;121:64–72. 10.1378/chest.121.1.64 - DOI - PubMed
    1. Sanders DB, Bittner RC, Rosenfeld M, et al. . Pulmonary exacerbations are associated with subsequent FEV1 decline in both adults and children with cystic fibrosis. Pediatr Pulmonol 2011;46:393–400. 10.1002/ppul.21374 - DOI - PubMed
    1. Robson M, Abbott J, Webb K, et al. . A cost description of an adult cystic fibrosis unit and cost analyses of different categories of patients. Thorax 1992;47:684–9. 10.1136/thx.47.9.684 - DOI - PMC - PubMed
    1. de Boer K, Vandemheen KL, Tullis E, et al. . Exacerbation frequency and clinical outcomes in adult patients with cystic fibrosis. Thorax 2011;66:680–5. 10.1136/thx.2011.161117 - DOI - PubMed

Publication types