Pharmacotherapy Follow-up in Older HIV-infected Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pharmacotherapy Follow-up in Older HIV-infected Patients: Impact on Cardiovascular Risk and Quality of Life

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Pharmaceutical care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaceutical care<br>Dader method. Health education for lifestyle modification. Improve adherence. Resolution of negative outcome associated with medication. | Behavioral: Pharmaceutical care<br>* This is a quasi-experimental study and the same group will be evaluated before and after the follow up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, pharmaceutical care, older patients, cardiovascular risk, pharmacotherapy follow up