Randomised crossover trial of telemonitoring in chronic respiratory patients (TeleCRAFT trial)

Abstract

ObjectiveTo assess the impact of home telemonitoring on health service use and quality of life in patients with severe chronic lung disease.DesignRandomised crossover trial with 6 months of standard best practice clinical care (control group) and 6 months with the addition of telemonitoring.Participants68 patients with chronic lung disease (38 with COPD; 30 with chronic respiratory failure due to other causes), who had a hospital admission for an exacerbation within 6 months of randomisation and either used long-term oxygen therapy or had an arterial oxygen saturation (SpO2) of <90% on air during the previous admission. Individuals received telemonitoring (second-generation system) via broadband link to a hospital-based care team.Outcome measuresPrimary outcome measure was time to first hospital admission for an acute exacerbation. Secondary outcome measures were hospital admissions, general practitioner (GP) consultations and home visits by nurses, quality of life measured by EuroQol-5D and hospital anxiety and depression (HAD) scale, and self-efficacy score (Stanford).ResultsMedian (IQR) number of days to first admission showed no difference between the two groups—77 (114) telemonitoring, 77.5 (61) control (p=0.189). Hospital admission rate at 6 months increased (0.63 telemonitoring vs 0.32 control p=0.026). Home visits increased during telemonitoring; GP consultations were unchanged. Self-efficacy fell, while HAD depression score improved marginally during telemonitoring.ConclusionsTelemonitoring added to standard care did not alter time to next acute hospital admission, increased hospital admissions and home visits overall, and did not improve quality of life in chronic respiratory patients.Trial registration numberNCT02180919 (ClinicalTrials.gov).

Telemonitoring in Chronic Obstructive Pulmonary Disease (CHROMED). A Randomized Clinical Trial

“…Although a few studies have suggested that combining symptoms and physiological variables, such as pulse and oxygen saturation, can identify COPD exacerbations 34 , subsequent randomised trials have not shown any effect of monitoring on TTFH and/or patient's quality of life, similar to our findings [11][12][13]15,16 . However, while other trials recruited previously hospitalised patients, we studied COPD patients reporting two or more exacerbations in the previous year, i.e.…”

“…As there was no difference between study arms we can hypothesise that the attritions were mostly due to the multiple contacts for collecting questionnaires and the feeling of limitation in freedom to act induced by participating in a clinical trial rather than specific issues related to the monitoring procedures. The number of respiratory alerts per patients was roughly one every two months, a small number compared to other similar telemonitoring trials in which alerts were based on symptoms and/or other variables 11,12,41 . Compared to those studies, the monitoring system based on continuous self-evaluation of lung function by FOT led to neither a major increase in time burden for healthcare personnel nor an increase in drug prescriptions when compared to standard practice, allowing it to be incorporated into a clinical service.…”

“…To date, most tele-monitoring studies in COPD have monitored symptoms and simple physiological measures, such as heart rate and oxygen saturation, alongside enhanced clinical support [11][12][13][14][15] and only a few included physiological measurements such as peak expiratory flow rate 16 . The outcomes of these studies have been disappointing, with limited evidence of health or economic benefit 12,17 .…”

Longitudinal change of COPD assessment test (CAT) in a telehealthcare cohort is associated with exacerbation risk

“…The median CAT at study inclusion was 17 points (range 1-30, interquartile range [IQR] [13][14][15][16][17][18][19][20][21][22]. The compliance to fill out the weekly CAT was 91% (2,364 of 2,538 required entries) in our study population.…”

“…There are only few randomized controlled trials (RCTs) investigating THC for COPD and even less investigating HRQoL. [16][17][18][19][20][21][22][23] A study from the UK over 12 months found 20 It is important to mention that the THC interventions differed considerably between these studies. The "reaction interval" varied daily, weekly, every 2 weeks and monthly.…”