Skip to content

Intervenções Farmacêuticas sobre o tratamento medicamentoso dos idosos com Doença de Risco Cardiovascular

Pharmaceutical Interventions on the Complexity of Pharmacotherapy in the elderly with Cardiovascular Risk Disease: a randomized controlled clinical trial with a pharmacoeconomic study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8dvw5zp
Enrollment
Unknown
Registered
2022-12-22
Start date
2023-01-09
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polypharmacy

Interventions

Patients randomized to participate in the intervention group will receive the Pharmacotherapy Review service, provided by pharmacists. Pharmaceutical interventions carried out during this service will

Sponsors

Fundação Universidade Federal de Sergipe
Lead Sponsor
Fundação Universidade Federal de Sergipe
Collaborator

Eligibility

Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: Be aged 60 years or older; Perform outpatient follow-up by physicians from the study site; Having systemic arterial hypertension, diabetes mellitus and/or dyslipidemia; Having uncontrolled blood pressure, glycemic and/or lipid levels; Taking medication for a period equal to or greater than three months for one of the chronic conditions of the study, these drugs being: losartan potassium together or not with other medications (systemic arterial hypertension), metformin together or not with other medications (diabetes mellitus), simvastatin together or not with other drugs (dyslipidemia); Included patients or caregivers must sign the Free and Informed Consent Form (TCLE)

Exclusion criteria

Exclusion criteria: Patients diagnosed with resistant or secondary systemic arterial hypertension; History of myocardial infarction or stroke in the last six months; Diabetes and/or secondary dyslipidemia; End-stage renal disease (glomerular filtration rate <10mL/min or hemodialysis); Liver disease; Cancer treatment; Acquired immunodeficiency syndrome or anticoagulation; Unstable psychiatric illness; If the patient is already followed up by other clinical pharmacists; Inability to attend scheduled appointments

Design outcomes

Primary

MeasureTime frame
Primary outcome 1: Is related to Pharmacotherapy Complexity, which will be analyzed using the MRCI instrument (GEORGE et al., 2005; MELCHIORS et al., 2007). 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 pharmacotherapy) and section C (additional instructions, if present on medication). Each section will be evaluated individually, adding the result of the three sections to obtain the patient's individual MRCI.;Primary outcome 2: It is related to the clinical outcomes associated with health conditions that are a cardiovascular risk factor determined by the number of patients who will reach the therapeutic goals recommended for the clinical parameter(s) referring to each clinical condition established as an inclusion criterion. The parameters, as well as the therapeutic goals will be established according to Clinical Guidelines and Protocols.

Secondary

MeasureTime frame
Secondary outcome 1: It is related to the economic outcomes will be measured from the purchase and supply of medicines, emergency care, hospital admission and outpatient consultations. The reduction in the cost of supplying medicines will be raised from the withdrawal of unnecessary medicines, dose reduction, and/or exchange of medicine for another one of lower cost. The costs related to outpatient consultations, emergency care or hospital admission during the 12 months will be calculated between the control and intervention groups and also through the Procedures Table Management System - SIGTAP.;Secondary outcome 2: It is related to the results of resolution and prevention of pharmacotherapeutic problems comparing before and after pharmaceutical interventions. These problems will be classified in need, effectiveness, safety and adherence in order to solve pharmacotherapeutic problems (CIPOLLE et al., 2004).

Countries

Brazil

Contacts

Public ContactFernanda Feitosa

Fundação Universidade Federal de Sergipe

fernandavf94@gmail.com+55 079 99907-6844

Outcome results

None listed

Source: REBEC (via WHO ICTRP)