Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial

Abstract

Objective: To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients' management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice.

Design: 24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial.

Setting: 15 general practices in the eastern part of the Netherlands.

Participants: Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded.

Interventions: A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients' own initiative).

Outcome measures: The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients' management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale.

Results: 165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58).

Conclusions: Comprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group.

Trial registration: Clinical trials NCT00128765.

Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no authors received any support from any company for the submitted work; no authors have any relationship with any company that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

Fig 1 Flow diagram of study. *Eligibility was assessed in general practice by measurement of pre-bronchodilator and post-bronchodilator lung function and collection of data on sociodemographic characteristics, smoking habits, current medical conditions, and current use of respiratory drugs. FEV1= forced expiratory volume in one second; FVC=forced vital capacity

Fig 2 Changes in unadjusted means of chronic respiratory questionnaire total score during 24 months of follow-up for the self management, routine monitoring, and usual care groups. Bars indicate 95% CIs

Fig 3 Percentages of patients with clinically important improvements (≥0.5 improvement from baseline) in chronic respiratory questionnaire (CRQ) total score during 24 months of follow-up