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 measuresThe 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). ConclusionsComprehensive 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.

There is an urgent need for consensus on what defines a chronic obstructive pulmonary disease (COPD) self-management intervention. We aimed to obtain consensus regarding the conceptual definition of a COPD self-management intervention by engaging an international panel of COPD self-management experts using Delphi technique features and an additional group meeting.In each consensus round the experts were asked to provide feedback on the proposed definition and to score their level of agreement (1=totally disagree; 5=totally agree). The information provided was used to modify the definition for the next consensus round. Thematic analysis was used for free text responses and descriptive statistics were used for agreement scores.In total, 28 experts participated. The consensus round response rate varied randomly over the five rounds (ranging from 48% (n=13) to 85% (n=23)), and mean definition agreement scores increased from 3.8 (round 1) to 4.8 (round 5) with an increasing percentage of experts allocating the highest score of 5 (round 1: 14% (n=3); round 5: 83% (n=19)).In this study we reached consensus regarding a conceptual definition of what should be a COPD self-management intervention, clarifying the requisites for such an intervention. Operationalisation of this conceptual definition in the near future will be an essential next step.

BackgroundThe effects of written action plans on recovery from exacerbations of chronic obstructive pulmonary disease (COPD) have not been well studied. The aims of this study were to assess the effects of adherence to a written action plan on exacerbation recovery time and unscheduled healthcare utilisation and to explore factors associated with action plan adherence. Methods This was a 1-year prospective cohort study embedded in a randomised controlled trial. Exacerbation data were recorded for 252 patients with COPD who received a written action plan for prompt treatment of exacerbations with the instructions to initiate standing prescriptions for both antibiotics and prednisone within 3 days of exacerbation onset. Following the instructions was defined as adherence to the action plan.Results From the 288 exacerbations reported by 143 patients, start dates of antibiotics or prednisone were provided in 217 exacerbations reported by 119 patients (53.8% male, mean age 65.4 years, post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) 43.9% predicted). In 40.1% of exacerbations, patients adhered to their written action plan. Adherence reduced exacerbation recovery time with statistical (p¼0.0001) and clinical (À5.8 days) significance, but did not affect unscheduled healthcare utilisation (OR 0.94, 95% CI 0.49 to 1.83). Factors associated with an increased likelihood of adherence were influenza vaccination, cardiac comorbidity, younger age and lower FEV 1 as percentage predicted. Conclusions This study shows that adherence to a written action plan is associated with a reduction in exacerbation recovery time by prompt treatment. Knowing the factors that are associated with proper and prompt utilisation of an action plan permits healthcare professionals to better focus their self-management support on appropriate patients.

BackgroundMany patients with chronic obstructive pulmonary disease (COPD) suffer from exacerbations, a worsening of their respiratory symptoms that warrants medical treatment. Exacerbations are often poorly recognized or managed by patients, leading to increased disease burden and health care costs.ObjectiveThis study aimed to examine the effects of a smart mobile health (mHealth) tool that supports COPD patients in the self-management of exacerbations by providing predictions of early exacerbation onset and timely treatment advice without the interference of health care professionals.MethodsIn a multicenter, 2-arm randomized controlled trial with 12-months follow-up, patients with COPD used the smart mHealth tool (intervention group) or a paper action plan (control group) when they experienced worsening of respiratory symptoms. For our primary outcome exacerbation-free time, expressed as weeks without exacerbation, we used an automated telephone questionnaire system to measure weekly respiratory symptoms and treatment actions. Secondary outcomes were health status, self-efficacy, self-management behavior, health care utilization, and usability. For our analyses, we used negative binomial regression, multilevel logistic regression, and generalized estimating equation regression models.ResultsOf the 87 patients with COPD recruited from primary and secondary care centers, 43 were randomized to the intervention group. We found no statistically significant differences between the intervention group and the control group in exacerbation-free weeks (mean 30.6, SD 13.3 vs mean 28.0, SD 14.8 weeks, respectively; rate ratio 1.21; 95% CI 0.77-1.91) or in health status, self-efficacy, self-management behavior, and health care utilization. Patients using the mHealth tool valued it as a more supportive tool than patients using the paper action plan. Patients considered the usability of the mHealth tool as good.ConclusionsThis study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan. Participants were positive about the supportive function and the usability of the mHealth tool. mHealth may be a valuable alternative for COPD patients who prefer a digital tool instead of a paper action plan.Trial RegistrationClinicalTrials.gov NCT02553096; https://clinicaltrials.gov/ct2/show/NCT02553096.