Pharmacotherapy Follow-up in Older HIV-infected Patients
Pharmacotherapy Follow-up in Older HIV-infected Patients: Impact on Cardiovascular Risk and Quality of Life
Cardiovascular diseases (CVD) are the main cause of death in Spain. In HIV patients, the uncontrolled viral replication, antiretroviral therapy (ART) and coinfections contribute to develop metabolic diseases and increase the prevalence of risk factors for CVD. These patients are aging which results in a higher probability of comorbidities, increased number of medications, possibility of having a negative outcome associated with medication (NOM) and increased cardiovascular risk (CVR). Various studies have established that pharmaceutical care (PC) results in better control of cardiovascular risk factors.
The purpose of this study is to evaluate the impact of pharmaceutical care achieved through pharmacotherapy follow-up on cardiovascular risk and health related quality of life (HRQoL) of HIV patients older than 50.
Visão geral do estudo
Descrição detalhada
Quasi-experimental clinical study, pre-post intervention, performed with one patient cohort.
Study will be carry out at a tertiary hospital. The population will be constituted of patients who receive care from the outpatient department of the pharmacy service in use of antiretroviral therapy.
Variables will be obtained from patients' clinical histories, from dispensing records and through interviews with patients.
Main variables:
- cardiovascular risk estimated according to Systematic Coronary Risk Evaluation (SCORE) and Registre Gironí del Cor (REGICOR) equations
- HRQoL measured by the Short-Form 36-Item Health Survey (SF-36) and Medical Outcomes Study HIV Health Survey (MOS-HIV) questionnaires.
Other variables: sociodemographic, clinical, pharmacological, related to CVR, related to NOM and to the interventions.
Interventions will be performed every two months until complete 12 months of follow-up. Pharmacotherapy follow-up will be conducted according to the Dader method. The interventions will be health education for lifestyle modification, improve adherence and aimed to the resolution of NOM and drug-related problems.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Granada, Espanha
- Hospital Universitario Virgen de las Nieves
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- patients older than 50 years
- in use of antiretroviral therapy
- cardiovascular risk ≥2%, estimated by the SCORE equation
- accept to participate in the research through the signature of a written informed consent
Exclusion Criteria:
- patients with neurodegenerative deficit or HIV dementia
- participants in clinical trials
- non signature of a written informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Pharmaceutical care
Dader method.
Health education for lifestyle modification.
Improve adherence.
Resolution of negative outcome associated with medication.
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This is a quasi-experimental study and the same group will be evaluated before and after the follow up.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cardiovascular risk estimation
Prazo: Baseline and 12 months
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Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
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Cardiovascular risk estimation
Prazo: Baseline and 12 months
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Change in cardiovascular risk estimated by REGICOR equation will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
|
|
Health-related quality of life
Prazo: Baseline and 12 months
|
Change in health-related quality of life measured by SF-36 questionnaire will be evaluated after one year of Pharmaceutical Care.
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Baseline and 12 months
|
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Health-related quality of life
Prazo: Baseline and 12 months
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Change in health-related quality of life measured by MOS-HIV questionnaire will be evaluated after one year of Pharmaceutical Care.
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Baseline and 12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Systolic and diastolic blood pressure
Prazo: Baseline and 12 months
|
Change in systolic and diastolic blood pressure will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
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Total cholesterol levels
Prazo: Baseline and 12 months
|
Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
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High-density lipoprotein (HDL-c) levels
Prazo: Baseline and 12 months
|
Change in HDL-c will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
|
Low-density lipoprotein (LDL-c) levels
Prazo: Baseline and 12 months
|
Change in LDL-c will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
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Triglycerides levels
Prazo: Baseline and 12 months
|
Change in triglycerides levels will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
|
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Glucose levels
Prazo: Baseline and 12 months
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Change in glucose levels will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
|
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Number of patients with smoking cessation
Prazo: Baseline and 12 months
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Patients that achieve smoking cessation after one year of Pharmaceutical Care
|
Baseline and 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Elza Aparecida M Domingues, MSc, Universidad de Granada
- Diretor de estudo: Miguel Angel Calleja Hernandez, PhD, University Hospital Virgen de las Nieves
- Diretor de estudo: Monica Ferrit Martin, PhD, University Hospital Virgen de las Nieves
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- University of Granada
Plano para dados de participantes individuais (IPD)
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