A prospective randomised controlled mixed-methods pilot study of home monitoring in adults with cystic fibrosis

Abstract

Background: Home monitoring (HM) is able to detect more pulmonary exacerbations (PEx) than routine care (RC) in individuals with cystic fibrosis (CF), but there is currently no evidence for benefits in health outcomes. Patient experiences of using HM and a health economics assessment have not been rigorously assessed to date. This study aimed to assess the effects of HM 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 pilot study recruited CF adults cared for in one large regional CF centre. Participants were randomly allocated 1:1 to the intervention cohort [twice-weekly HM 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 cohort (routine clinical care) for the 12-month study period. Measurements were recorded at study visits at baseline, 3, 6, 9 and 12 months. Spirometry, body weight, comorbidities, medications, hospital inpatient days, courses of antibiotics (oral and intravenous) and PEx (defined by the modified Fuchs criteria) were recorded at each study visit. Health status, capability and cost-effectiveness were 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 of HM was assessed by semi-structured qualitative interviews at baseline and 12 months. Results: Eighty-eight participants were recruited, with 44 (50%) randomised to receive HM and 44 (50%) randomised to receive RC. Patient hospital inpatient bed days per annum and overall health-related quality of life were similar between the groups. Protocol-defined PEx requiring intravenous and oral antibiotics were detected more frequently in the HM group, with no other differences between the groups in the secondary outcomes. The total mean National Health Service (NHS) costs were approximately £1500 more per patient for the RC arm than the HM group. The qualitative analysis demonstrated that the patient experience of HM was generally positive and overall the intervention was well accepted. Conclusion: The findings of this trial confirm that HM is effective in detecting PEx in adults with CF. There were no significant differences in hospital inpatient bed days and overall health-related quality of life between the groups. Despite the cost of the HM equipment and the salary of the research fellow to respond to the results, health economics analysis suggests the intervention was less expensive than RC. HM was generally well accepted, with most participants reporting that it resulted in them feeling more empowered and reassured. Trial registration The study protocol was registered with Clinicaltrials.gov (NCT02994706) on 16 July 2014 and published in a peer reviewed journal. Data from this trial has been presented in abstract form at the ECFS Conference in Lyon in September 2020.

Diagnosis and Management of Cystic Fibrosis Exacerbations

“…A recent prospective randomized controlled pilot trial using home monitoring to detect exacerbations enrolled 88 PwCF (44 in each arm) comparing twice weekly home assessments with spirometry and symptom measurement versus routine CF care much as in the earlier Early Intervention in CF Exacerbation (eICE) study. 149,150 Much as in the eICE study, home monitoring was able to identify exacerbations and reduced health care utilization costs but did not lead to fewer inpatient bed days or improved health-related quality of life. 149,150 Yet another large-scale randomized trial (n ¼ 607) randomized PwCF to improve adherence with a digital platform and behavioral change sessions or usual care with the goal of improving adherence and reducing exacerbation rates.…”

“…149,150 Much as in the eICE study, home monitoring was able to identify exacerbations and reduced health care utilization costs but did not lead to fewer inpatient bed days or improved health-related quality of life. 149,150 Yet another large-scale randomized trial (n ¼ 607) randomized PwCF to improve adherence with a digital platform and behavioral change sessions or usual care with the goal of improving adherence and reducing exacerbation rates. 151 This study did improve measures of adherence and nutrition (body mass index) over the yearlong intervention period but did not reduce exacerbation rate, lung function, or quality of life.…”

Impact of Digital Technologies on Clinical Care for Adults with Cystic Fibrosis

“…Trials are currently ongoing to further evaluate the impact of digital health technologies in the care of pwCF. In particular, the impact of telemonitoring, self-management apps, coaching on adherence and exercise, identification of pulmonary exacerbations, and impact on quality of life are currently assessed [63][64][65]…”