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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmaceutical care | Experimental | Dader method. Health education for lifestyle modification. Improve adherence. Resolution of negative outcome associated with medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmaceutical care | Behavioral | This is a quasi-experimental study and the same group will be evaluated before and after the follow up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular risk estimation | Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care | Baseline and 12 months |
| Cardiovascular risk estimation | 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 | Change in health-related quality of life measured by SF-36 questionnaire will be evaluated after one year of Pharmaceutical Care. | Baseline and 12 months |
| Health-related quality of life | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic blood pressure | Change in systolic and diastolic blood pressure will be evaluated after one year of Pharmaceutical Care | Baseline and 12 months |
| Total cholesterol levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elza Aparecida M Domingues, MSc | Universidad de Granada | Principal Investigator |
| Miguel Angel Calleja Hernandez, PhD | University Hospital Virgen de las Nieves | Study Director |
| Monica Ferrit Martin, PhD | University Hospital Virgen de las Nieves | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de las Nieves | Granada | Spain |
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| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care
| Baseline and 12 months |
| High-density lipoprotein (HDL-c) levels | Change in HDL-c will be evaluated after one year of Pharmaceutical Care | Baseline and 12 months |
| Low-density lipoprotein (LDL-c) levels | Change in LDL-c will be evaluated after one year of Pharmaceutical Care | Baseline and 12 months |
| Triglycerides levels | Change in triglycerides levels will be evaluated after one year of Pharmaceutical Care | Baseline and 12 months |
| Glucose levels | Change in glucose levels will be evaluated after one year of Pharmaceutical Care | Baseline and 12 months |
| Number of patients with smoking cessation | Patients that achieve smoking cessation after one year of Pharmaceutical Care | Baseline and 12 months |