A prospective pilot study of home monitoring in adults with cystic fibrosis (HOME-CF): protocol for a randomised controlled trial

Jocelyn Choyce, Karen L Shaw, Alice J Sitch, Hema Mistry, Joanna L Whitehouse, Edward F Nash, Jocelyn Choyce, Karen L Shaw, Alice J Sitch, Hema Mistry, Joanna L Whitehouse, Edward F Nash

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: This study protocol is registered with Clinicaltrials.gov ( NCT02994706 ), date registered 16th July 2014.

Keywords: Cystic fibrosis; Health economics; Health related quality of life; Home monitoring; Pulmonary exacerbations.

Figures

Fig. 1
Fig. 1
Flow of patients through the study

References

    1. Cystic Fibrosis Trust. UK Cystic Fibrosis Registry 2015 Annual Data Report. 2016.
    1. 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]
    1. Elborn JS. Cystic fibrosis. Lancet. 2016. [Epub ahead of print]
    1. Dodge JA, Lewis PA, Stanton M, Wilsher J. Cystic fibrosis mortality and survival in the UK: 1947-2003. Eur Respir J. 2007;29(3):522–6. doi: 10.1183/09031936.00099506.
    1. Goss CH, Edwards TC, Ramsey BW, Aitken ML, Patrick DL. Patient-reported respiratory symptoms in cystic fibrosis. J Cyst Fibros. 2009;8(4):245–52. doi: 10.1016/j.jcf.2009.04.003.
    1. Tagliente I, Trieste L, Solvoll T, Murgia F, Bella S. Telemonitoring in cystic fibrosis: a 4-year assessment and simulation for the next 6 years. Interact J Med Res. 2016;5(2):e11. doi: 10.2196/ijmr.5196.
    1. Roehrer E, Cummings E, Beggs S, Turner P, Hauser J, Micallef N, Ellis L, Reid D. Pilot evaluation of web enabled symptom monitoring in cystic fibrosis. Inform Health Soc Care. 2013;38(4):354–65. doi: 10.3109/17538157.2013.812646.
    1. 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.
    1. 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.
    1. Sarfaraz S, Sund Z, Jarad N. Real-time, once-daily monitoring of symptoms and FEV in cystic fibrosis patients - a feasibility study using a novel device. Clin Respir J. 2010;4(2):74–82. doi: 10.1111/j.1752-699X.2009.00147.x.
    1. Grzincich G, Gagliardini R, Bossi A, Bella S, Cimino G, Cirilli N, Viviani L, Iacinti E, Quattrucci S. Evaluation of a home telemonitoring service for adult patients with cystic fibrosis: a pilot study. J Telemed Telecare. 2010;16(7):359–62. doi: 10.1258/jtt.2010.091006.
    1. Wilkinson OM, Duncan-Skingle F, Pryor JA, Hodson ME. A feasibility study of home telemedicine for patients with cystic fibrosis awaiting transplantation. J Telemed Telecare. 2008;14(4):182–5. doi: 10.1258/jtt.2008.070107.
    1. Finkelstein SM, Wielinski CL, Kujawa SJ, Loewenson R, Warwick WJ. The impact of home monitoring and daily diary recording on patient status in cystic fibrosis. Pediatr Pulmonol. 1992;12(1):3–10. doi: 10.1002/ppul.1950120104.
    1. Aitken ML, Caldwell E, Wilhelm E, Goss CH. Early intervention in pulmonary exacerbation. Pediatr Pulmonol. 2011;46(S34):A331.
    1. Lechtzin N, West N, Allgood S, Wilhelm E, Khan U, Mayer-Hamblett N, Aitken ML, Ramsey BW, Boyle MP, Mogayzel PJ, Jr, 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. doi: 10.1016/j.cct.2013.09.004.
    1. Moher M, Schultz K, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357(4):1191–1194. doi: 10.1016/S0140-6736(00)04337-3.
    1. Quittner AL, Buu A, Messer MA, Modi AC, Watrous M. Development and validation of The Cystic Fibrosis Questionnaire in the United States: a health-related quality-of-life measure for cystic fibrosis. Chest. 2005;128(4):2347–54. doi: 10.1378/chest.128.4.2347.
    1. Fuchs HJ, Borowitz DS, Christiansen DH, et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. The Pulmozyme Study Group. N Engl J Med. 1994;331(10):637–642. doi: 10.1056/NEJM199409083311003.
    1. Miller M, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten C, Gustafsson C, Jensen R, Johnson D, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J. Standardisation of spirometry. Eur Respir J. 2005;26(2):319–338. doi: 10.1183/09031936.05.00034805.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–43. doi: 10.3109/07853890109002087.
    1. Al-Janabi H, Flynn TN, Coast J. Development of a self-report measure of capability wellbeing for adults: the ICECAP-A. Qual Life Res. 2012;21(1):167–76. doi: 10.1007/s11136-011-9927-2.
    1. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277–88. doi: 10.1177/1049732305276687.
    1. 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.
    1. O'Cathain A, Murphy E, Nicholl J, A. Three techniques for integrating data in mixed methods studies. BMJ. 2010;341:c4587–c4587.
    1. 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.
    1. 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.

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