Diabetes Mellitus
Conditions
Interventions
Sample: 100 elderly patients with cardiovascular risk diseases
The main objective of the intervention process is to optimize FC, and it will be developed based on pharmacotherapy review models and standards used in countries whose practice is consolidated.
The fr
Sponsors
Fundação Universidade Federal de Sergipe
Fundação Universidade Federal de Sergipe
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Be 60 years of age or older; Carry out outpatient follow-up by outpatient physicians; Have at least one of the following diagnosed clinical conditions: systemic arterial hypertension, diabetes mellitus and dyslipidemia, according to the criteria recommended by the Brazilian guidelines for these clinical conditions; Present uncontrolled blood pressure and/or glycemic and/or lipid levels in accordance with established goals for the level of cardiovascular risk; Use medication for at least one of the chronic conditions mentioned above for more than six months
Exclusion criteria
Exclusion criteria: Diagnosis of resistant or secondary systemic arterial hypertension; Diabetes and/or secondary dyslipidemia; End stage of kidney disease; Liver disease; Cancer treatment; Acquired immunodeficiency syndrome or anticoagulation; Unstable psychiatric illness; Service provided by other pharmacists; Inability to attend scheduled appointments; Missing in more than two consecutive appointments; Withdrawal from participating in the study at any stage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Medication Regimen Complexity will be analyzed using the Medication Regimen Complexity Index instrument developed by George and collaborators in 2005, translated and validated to Brazilian Portuguese by Melchiors and collaborators in 2007. This instrument will only be applied to medications prescribed by the physician and/or prescribed by the pharmacist, evaluated based on information contained in the official monograph or medical prescription. This instrument includes 65 items divided into three sections in which the following factors will be evaluated, section A, dosage forms present in pharmacotherapy; section B, dose frequency for each drug in the pharmacotherapy; and section C, additional instructions, if present in the treatment. Each section will be evaluated individually, adding the result of the three sections to obtain the patient's individual Medication Regimen Complexity index. This assessment will be carried out in accordance with the recommendations contained in the instrument | — |
Secondary
| Measure | Time frame |
|---|---|
| Adherence to pharmacotherapy, which is considered the measure of how far patients can follow the instructions for the prescribed treatments, which will be assessed using two methods; The indirect method will be defined through the instrument “Brief Medication Questionnaire”, which is divided into three domains regarding barriers related to adherence to pharmacotherapy: regimen, beliefs and recall. Patients will be classified into: adherent, likely adherence, likely low adherence and low adherence; Direct method, to confirm whether the medications were actually ingested, plasma determinations of some of the medications prescribed for the treatment of the elderly included in this study will be performed. The selected drugs; Losartan potassium, Metformin and Simvastatin will be considered biological markers of treatment adherence. Therefore, high performance liquid chromatography coupled with mass spectrometry will be used in the analysis step and liquid-liquid extraction in the sample preparation step. This method is considered the “gold standard” in assessing adherence. The blood sample will be collected and stored in the laboratory of the hospital studied, by a pharmacist from the project team. At the end of each day, the pharmacist will forward the samples to the place where the analysis will be performed. The analysis will be carried out from the following steps; plasma samples, chromatographic analyses, sample preparation procedure and application of methods to assess treatment adherence. The results regarding adherence to pharmacotherapy in both methods will be compared before and after pharmaceutical interventions, to verify whether the reduction of medication regimen complexity influenced the improvement of adherence to pharmacotherapy;The humanistic results will be evaluated using the following indicators; Quality of life will be determined through the instrument Medical Outcomes Study 36-item short-form health survey SF-36 developed by Ciconelli et al. in 19 | — |
Countries
Brazil
Contacts
Public ContactVanessa Conceição
Outcome results
None listed