SMART CF - A smartphone application for reporting symptoms in adults with cystic fibrosis

In adults with cystic fibrosis, what is the effect of a smartphone application used to report symptoms versus usual care on exacerbations requiring intravenous antibiotics, healthcare utilisation, lung function, quality of life, anxiety and depression, nutritional status, medication adherence and absenteeism and presenteeism.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000599572

Acronym

SMART CF

Enrollment

Registered

2015-06-09

Start date

2016-01-28

Completion date

2017-02-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cystic fibrosis (CF) is the most common Caucasian genetic disease and has a reduced life expectancy of approximately 40 years of age. The decline in lung function in CF is accelerated by exacerbations. Severe exacerbations require treatment with intravenous antibiotics (IVABs), but of concern many do not regain the lung function they have lost following treatment. One of the major factors in this failure to regain lung function is the delay in time it takes for the individual with CF to present to the CF centre to report symptoms and commence treatment. In collaboration with Curtin University and the Burke Rehabilitation and Research Institute in New York, USA, we have developed a smartphone application that can be used by participants to report their symptoms to the CF team at Sir Charles Gairdner Hospital on a weekly basis or sooner if they feel they need to. We will now aim to complete a 12 month randomised controlled trial in 60 participants, investigating the impact of using this smartphone application on the number of exacerbations requiring IVABs per participant, as well as other health outcomes and measures of healthcare utilisation.

Interventions

Smartphone application. Participants will use their own smartphone to answer 10 questions relating to their respiratory symptoms and 2 questions relating to their emotional wellbeing on a weekly basis (or sooner if they choose) for a 12 month period. Answers will be emailed securely to the CF team and contact will be made with the participant if the responses indicate a potential exacerbation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of CF; aged 18 years or older; under the care of the Sir Charles Gairdner Hospital (SCGH) CF team; clinically stable at time of recruitment; exacerbation requiring IVABs in the preceding 12 months.

Exclusion criteria

Lung transplantation or currently listed for lung transplantation; current pregnancy; inability to provide informed consent.

Outcome results