Pharmacotherapy Follow-up in Older HIV-infected Patients: Impact on Cardiovascular Risk and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Cardiovascular risk estimation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patients with neurodegenerative deficit or HIV dementia
- •participants in clinical trials
- •non signature of a written informed consent
结局指标
主要结局
Cardiovascular risk estimation
时间窗: Baseline and 12 months
Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care
Health-related quality of life
时间窗: 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.
次要结局
- High-density lipoprotein (HDL-c) levels(Baseline and 12 months)
- Triglycerides levels(Baseline and 12 months)
- Glucose levels(Baseline and 12 months)
- Low-density lipoprotein (LDL-c) levels(Baseline and 12 months)
- Systolic and diastolic blood pressure(Baseline and 12 months)
- Total cholesterol levels(Baseline and 12 months)
- Number of patients with smoking cessation(Baseline and 12 months)
研究者
Elza Aparecida Machado Domingues
MSc
Universidad de Granada