Home monitoring has the potential to detect early pulmonary exacerbations in people with cystic fibrosis (CF), with consequent improvements in health outcomes and healthcare associated costs. This study aims to assess the effects of home monitoring on hospital admissions, quality of life, antibiotic requirements, exacerbation frequency, lung function, nutritional outcomes, anxiety, depression, costs and health outcomes, as well as the qualitative effects on the patient experience.
This randomised controlled mixed-methods trial aims to recruit 100 adults with CF cared for in one large regional CF centre. Participants are randomly allocated 1:1 to the intervention group (twice-weekly home monitoring of symptoms measured by the Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) and Forced Expiratory Volume in one second (FEV1)) or a control group (routine clinical care) for the 12-month study period. Measurements are recorded at study visits at baseline, 3, 6, 9 and 12 months. Spirometry, body weight, co-morbidities, medications, hospital inpatient days, courses of antibiotics (oral and intravenous), pulmonary exacerbations (defined by the modified Fuchs criteria) are recorded at each study visit. Health status, capability and health economics are measured at each study visit by the Hospital Anxiety and Depression Scale (HADS), the ICEpop CAPability measure for Adults (ICECAP-A), EuroQol 5 dimensions (EQ-5D-5L) questionnaire and an adapted resource use questionnaire. The patient experience is assessed by semi-structured qualitative interviews at baseline and 12 months.
Results from this study will help to determine the effect of home monitoring on inpatient bed days and quality of life in adults with CF, as well as other relevant health and health economic outcomes.
This study protocol is registered with Clinicaltrials.gov (NCT02994706), date registered 16th July 2014
Cystic Fibrosis Trust. UK Cystic Fibrosis Registry 2015 Annual Data Report. 2016.
Heltshe SL, Cogen J, Ramos KJ, Goss CH. Cystic Fibrosis: The Dawn of a New Therapeutic Era. Am J Respir Crit Care Med. 2016. [Epub ahead of print]
Elborn JS. Cystic fibrosis. Lancet. 2016. [Epub ahead of print]
Bella S, Murgia F, Cotognini C, Alghisi F, Montemitro E. Program of home telemonitoring in patients with cystic fibrosis over a period of 2 years: a contribution to the rationalization of care. Clin Ter. 2013;164(4):e313–7. PubMed
Murgia F, Cilli M, Renzetti E, Majo F, Soldi D, Lucidi V, Bella F, Bella S. Remote telematic control in cystic fibrosis. Clin Ter. 2011;162(4):e121–4. PubMed
Aitken ML, Caldwell E, Wilhelm E, Goss CH. Early intervention in pulmonary exacerbation. Pediatr Pulmonol. 2011;46(S34):A331.
Lechtzin N, West N, Allgood S, Wilhelm E, Khan U, Mayer-Hamblett N, Aitken ML, Ramsey BW, Boyle MP, Mogayzel Jr PJ, Goss CH. Rationale and design of a randomized trial of home electronic symptom and lung function monitoring to detect cystic fibrosis pulmonary exacerbations: the early intervention in cystic fibrosis exacerbation (eICE) trial. Contemp Clin Trials. 2013;36(2):460–9. CrossRefPubMed
Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13(1):117.
O'Cathain A, Murphy E, Nicholl J, A. Three techniques for integrating data in mixed methods studies. BMJ. 2010;341:c4587–c4587.
de Boer K, Vandemheen KL, Tullis E, Doucette S, Fergusson D, Freitag A, Paterson N, Jackson M, Lougheed MD, Kumar V, Aaron SD. Exacerbation frequency and clinical outcomes in adult patients with cystic fibrosis. Thorax. 2011;66(8):680–685.
Sanders DB, Bittner RCL, Rosenfeld M, Hoffman LR, Redding GJ, Goss CH. Failure to Recover to Baseline Pulmonary Function after Cystic Fibrosis Pulmonary Exacerbation. Am J Respir Crit Care Med. 2010;182(5):627–632.
- A prospective pilot study of home monitoring in adults with cystic fibrosis (HOME-CF): protocol for a randomised controlled trial
Karen L. Shaw
Alice J. Sitch
Joanna L. Whitehouse
Edward F. Nash
- BioMed Central
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