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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Granada、西班牙
- Hospital Universitario Virgen de las Nieves
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cardiovascular risk estimation
大体时间：Baseline and 12 months
|
Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
|
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Cardiovascular risk estimation
大体时间：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
|
Baseline and 12 months
|
|
Health-related quality of life
大体时间：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
大体时间：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.
|
Baseline and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Systolic and diastolic blood pressure
大体时间：Baseline and 12 months
|
Change in systolic and diastolic blood pressure will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
|
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Total cholesterol levels
大体时间：Baseline and 12 months
|
Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
|
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High-density lipoprotein (HDL-c) levels
大体时间：Baseline and 12 months
|
Change in HDL-c will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
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Low-density lipoprotein (LDL-c) levels
大体时间：Baseline and 12 months
|
Change in LDL-c will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
|
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Triglycerides levels
大体时间：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
大体时间：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
大体时间：Baseline and 12 months
|
Patients that achieve smoking cessation after one year of Pharmaceutical Care
|
Baseline and 12 months
|
合作者和调查者
调查人员
- 首席研究员：Elza Aparecida M Domingues, MSc、Universidad de Granada
- 研究主任：Miguel Angel Calleja Hernandez, PhD、University Hospital Virgen de las Nieves
- 研究主任：Monica Ferrit Martin, PhD、University Hospital Virgen de las Nieves
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- University of Granada
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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