Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): protocol for the ICEPOC study

Abstract

BackgroundLow therapeutic adherence to medication is very common. Clinical effectiveness is related to dose rate and route of administration and so poor therapeutic adherence can reduce the clinical benefit of treatment. The therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is extremely poor according to most studies. The research about COPD adherence has mainly focussed on quantifying its effect, and few studies have researched factors that affect non-adherence. Our study will evaluate the effectiveness of a multifactor intervention to improve the therapeutic adherence of COPD patients.Methods/DesignA randomized controlled clinical trial with 140 COPD diagnosed patients selected by a non-probabilistic method of sampling. Subjects will be randomly allocated into two groups, using the block randomization technique. Every patient in each group will be visited four times during the year of the study. Intervention: Motivational aspects related to adherence (beliefs and behaviour): group and individual interviews; cognitive aspects: information about illness; skills: inhaled technique training. Reinforcement of the cognitive-emotional aspects and inhaled technique training will be carried out in all visits of the intervention group.DiscussionAdherence to a prescribed treatment involves a behavioural change. Cognitive, emotional and motivational aspects influence this change and so we consider the best intervention procedure to improve adherence would be a cognitive and emotional strategy which could be applied in daily clinical practice. Our hypothesis is that the application of a multifactor intervention (COPD information, dose reminders and reinforcing audiovisual material, motivational aspects and inhalation technique training) to COPD patients taking inhaled treatment will give a 25% increase in the number of patients showing therapeutic adherence in this group compared to the control group.We will evaluate the effectiveness of this multifactor intervention on patient adherence to inhaled drugs considering that it will be right and feasible to the clinical practice context.Trial registrationCurrent Controlled Trials ISCTN18841601

Factors Influencing Adherence to Treatment in COPD Patients and Its Relationship with Disease Exacerbations

“…Furthermore, when the patient learns how to manage on his/her own in the case of COPD exacerbations, it results in a reduction in their number and duration, and improves control of the disease [10,17,46].…”

“…Better knowledge may significantly improve patients' adherence to treatment, reduce the number of exacerbations of the disease and ameliorate the quality of life. In particular, understanding the objectives of treatment, the mechanisms of drugs' activity and repeated training in inhalation techniques may be of vital importance [17,19,45,46].…”

“…However, it is necessary to undergo systematic and appropriate treatment. Meanwhile, the studies conducted in different countries have shown that although in clinical studies patients take 70-90% of prescribed drug doses [15][16][17][18], only 50% of patients adhere to medical recommendations in everyday practice [19][20][21][22].…”

An official American Thoracic Society/European Respiratory Society statement: research questions in COPD

“…nebuliser or inhaler) and various behavioural approaches (e.g. assessing inhaler technique); however, the effectiveness of such interventions has not been confirmed due to insufficient study [147][148][149].…”

Non Adherence to Inhalational Medications and Associated Factors Among Patients with Asthma in A Referral Hospital in Ethiopia, Using Validated Tool Tai

“…Patient age, level of education/knowledge about the conditions, medication and lack of technical skill of delivery devices were taught to be the cause of nonadherence to inhaled medications [8][9][10][11]. In addition to this, complexity of the inhalation regimen, peculiarities of inhaler devices, type of inhaled agent, and a variety of patient beliefs and sociocultural and psychological factors also the cause poor adherence to inhalational medications.…”