OBJECTIVE: To evaluate the efficacy of an intervention by means of an educational magazine on treatment compliance in uncontrolled arterial hypertension (AHT). DESIGN: Controlled, randomised clinical trial. SETTING: 87 primary care centres. Spain. PARTICIPANTS: A total of 450 patients with uncontrolled hypertension were included. INTERVENTION: Two groups of 225 patients were formed: 1) Control group (CG): standard health intervention; 2) Intervention Group (IG): received a twice monthly educational magazine at home. MAIN MEASUREMENTS: Compliance was measured using the Medication Event Monitoring System (MEMS-Aardex). Compliance rate (CR) was recorded. Compliers were defined as individuals with a treatment compliance of 80-110%. The percentage of compliers, the mean percentage of doses taken and the percentage of patients taking the medication at the correct times were estimated. The mean blood pressures (BPs) and the percentage of controlled patientswere calculated. The number needed to treat (NNT) was calculated. RESULTS: A total of 393 individuals were evaluable (Age: 62.4 years), 196 in the IG and 197 in the CG. There were 83.2% (95% CI 78-88.4) and 49.2% (95% CI 42.2-56.2) (P=0.0001) of overall compliers in the IG and CG, respectively and 74% (95% CI: 67.9-80.1) and 42.6% (95% CI=35.7-49.5) (P=0.0001) of correct times compliers. A total of 81.6% (95% CI=76.2-86.5%)) were controlled in the IG and 56.3% (95% CI=49.4-63.2) in the CG. The NNT was 3.3 patients. CONCLUSIONS: Therapeutic non-compliance was very high. The educational magazine is an effective strategy to improve the compliance and degree of control of the AHT.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of an intervention by means of an educational magazine on treatment compliance in uncontrolled arterial hypertension (AHT). DESIGN: Controlled, randomised clinical trial. SETTING: 87 primary care centres. Spain. PARTICIPANTS: A total of 450 patients with uncontrolled hypertension were included. INTERVENTION: Two groups of 225 patients were formed: 1) Control group (CG): standard health intervention; 2) Intervention Group (IG): received a twice monthly educational magazine at home. MAIN MEASUREMENTS: Compliance was measured using the Medication Event Monitoring System (MEMS-Aardex). Compliance rate (CR) was recorded. Compliers were defined as individuals with a treatment compliance of 80-110%. The percentage of compliers, the mean percentage of doses taken and the percentage of patients taking the medication at the correct times were estimated. The mean blood pressures (BPs) and the percentage of controlled patientswere calculated. The number needed to treat (NNT) was calculated. RESULTS: A total of 393 individuals were evaluable (Age: 62.4 years), 196 in the IG and 197 in the CG. There were 83.2% (95% CI 78-88.4) and 49.2% (95% CI 42.2-56.2) (P=0.0001) of overall compliers in the IG and CG, respectively and 74% (95% CI: 67.9-80.1) and 42.6% (95% CI=35.7-49.5) (P=0.0001) of correct times compliers. A total of 81.6% (95% CI=76.2-86.5%)) were controlled in the IG and 56.3% (95% CI=49.4-63.2) in the CG. The NNT was 3.3 patients. CONCLUSIONS: Therapeutic non-compliance was very high. The educational magazine is an effective strategy to improve the compliance and degree of control of the AHT.
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