PRS4 Effectiveness Of a Multifactorial Intervention to Improve Adherence in Patients with Chronic Obstructive Pulmonary Disease (COPD) Icepoc Study

To assess the effectiveness on treatment adherence of a multifactorial intervention in patients with COPD. Design: Randomized Control Trial (ISRCTN 15106246) Patients: 146 subjects randomly allocated (random blocks of 4 patients) in two groups (intervention group: IG, control group: CG). Intervention components: 1) Motivational aspects related with adherence: beliefs-behaviour about COPD (group and individual interviews); 2) Cognitive aspects: information about illness; and 3) Skills: inhaling techniques training. Follow-up: 1 year, 5 visits/group: 1) V0 random allocation, all variables were measured; 2) V0C adherence was measured; 3) V1-V2 (3-6 moths after start/intervention) adherence and variable changes were measured; and 4) V3 (one year after start/intervention) all variables were measured. Primary Outcome: adherence (doses recount); Secondary Outcomes: functional status (spirometry), quality of life (Saint George Respiratory Questionnaire-SGRQ); Independent variables: age, sex, educational level, comorbidity, COPD severity stage (SEPAR guidelines), prescribed medication. Predominace of males (91.8%), mean age 69.01 years (CI95%, 67.58-70.44); low cultural level (78.1%), 32.2% current smokers (29.36 cigarettes/day [CI 95%, 26.03-32.7]) overweight (Body Mass Index 30.78 kg/m2 [CI 95%, 28.78-32.78]), 81.2% mild-moderate severity stage, predominance of obstructive respiratory pattern; FEV1 (mean)=68.76% (CI 95%, 65.23-72.29), 0.87 exacerbations/year [CI95%, 0.68-1.06]. Pharmacological treatment: inhaled-anticholinergic (77.4%); inhaled-beta2-adrenérgic (80.1%); inhaled-corticosteroids (70.5%); xantins (8.2%); oxygen therapy (4.8%); oral-corticosteroids (0.7%); mucolytics (11.6%). All these measurements were similar in both groups. Adherence was 41% (41.2CG/40.8IG). 93 patients (63.7%) completed follow-up. Adherence in follow-up V1=61.8% (58.9CG/65.2IG), V2=66.3% (63.2CG/71.1IG), V3=56.8% (43.1CG/72.7IG). Significative differences between study groups (p=0.004). NNT for intervention:6,8 .Multivariate analysis (Adherence): (specificity = 87.5%, sensibility = 60.4%): intervention [OR=6.066 (IC95%, 2.075-17.734) p=0.001], age [OR=0.93(IC95%, 0.87-0.994) p=0.032]. inhaled-beta2-adrenérgic [OR=0.101 (IC95%, 0.017-0.589) p=0.021] SGRQ-Impact scale [OR=1.064 (IC95%, 1.014-1.117) p=0.012], SGRQ-Activity scale [OR=0.96 (IC95%, 0.924-0.997) p=0.034]. The performed intervention improves adherence in patients with COPD.