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
Highlights
Low therapeutic adherence to medication is very common
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 chronic obstructive pulmonary disease (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
Summary
We have described the treatment adherence in a group of patients in the Málaga area in the previous studies and we have tried to validate easier and faster methods than the dose/pill count, to evaluate the non-adherence magnitude in these patients. Our hypothesis is that the application of a multifactor intervention to COPD patients under scheduled inhaled treatment will increase up to 25% the percentage of adherent patients in this group in comparison to the control group. This intervention could be feasible to implement in the clinical practice context. Authors’ contributions 1) PBF has been involved in drafting the manuscript and writing it She has participated in the design of the study and the intervention. 6) FLF has been involved in drafting the manuscript and writing it Competing interests The authors declare that they have no competing interests
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