Home Monitoring in Patients with Idiopathic Pulmonary Fibrosis. A Randomized Controlled Trial

Am J Respir Crit Care Med. 2020 Aug 1;202(3):393-401. doi: 10.1164/rccm.202002-0328OC.

Abstract

Rationale: Idiopathic pulmonary fibrosis (IPF) is a deadly disease with increasingly impaired health-related quality of life (HRQOL). eHealth technologies facilitate collection of physiological outcomes and patient-reported outcomes at home, but randomized controlled trials (RCTs) on the effects of eHealth are scarce.Objectives: To investigate whether a home monitoring program improves HRQOL and medication use for patients with IPF.Methods: We performed a multicenter RCT in newly treated patients with IPF. Patients were randomly assigned to standard care or a home monitoring program on top of standard care for 24 weeks. The home monitoring program included home spirometry, reporting of symptoms and side effects, patient-reported outcomes, information, a medication coach, and eConsultations. The primary endpoint was between-group difference in change in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score at 24 weeks.Measurements and Main Results: A total of 90 patients were randomized (46 assigned to the home monitoring group and 44 to the standard care group). After 24 weeks, no statistically significant difference was found in K-BILD total score, with a 2.70-point increase in the home monitoring group (SD = 9.5) and a 0.03-point increase in the standard care group (SD = 10.4); between-group difference was 2.67 points (95% confidence interval [CI], -1.85 to 7.17; P = 0.24). Between-group difference in psychological domain score was 5.6 points (95% CI, -1.13 to 12.3; P = 0.10), with an increase of 5.12 points in the home monitoring group (SD = 15.8) and a decline of 0.48 points in the standard care group (SD = 13.3). In the home monitoring group, medication was more often adjusted (1 vs. 0.3 adjustments per patient; 95% CI, 0.2 to 1.3; P = 0.027). Patient satisfaction with the home monitoring program was high. Home-based spirometry was highly correlated with hospital-based spirometry over time.Conclusions: The results of this first-ever eHealth RCT in IPF showed that a comprehensive home monitoring program did not improve overall HRQOL measured with K-BILD but tended to improve psychological well-being. Home monitoring was greatly appreciated by patients and allowed for individually tailored medication adjustments.Clinical trial registered with www.clinicaltrials.gov (NCT03420235).

Keywords: eHealth; home spirometry; idiopathic pulmonary fibrosis; interstitial lung disease; quality of life.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anxiety / psychology
  • Depression / psychology
  • Disease Management
  • Female
  • Home Care Services*
  • Humans
  • Idiopathic Pulmonary Fibrosis / physiopathology
  • Idiopathic Pulmonary Fibrosis / psychology
  • Idiopathic Pulmonary Fibrosis / therapy*
  • Indoles / therapeutic use
  • Male
  • Middle Aged
  • Netherlands
  • Patient Reported Outcome Measures*
  • Pyridones / therapeutic use
  • Quality of Life*
  • Spirometry*
  • Telemedicine*
  • Vital Capacity

Substances

  • Indoles
  • Pyridones
  • pirfenidone
  • nintedanib

Associated data

  • ClinicalTrials.gov/NCT03420235