Clinical trial NCT02763995: Pharmacotherapy Follow-up in Older HIV-infected Patients
Official title: Pharmacotherapy Follow-up in Older HIV-infected Patients: Impact on Cardiovascular Risk and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
pharmaceutical care
older patients
cardiovascular risk
pharmacotherapy follow up
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular risk estimation
timeFrame: Baseline and 12 months
measure: Cardiovascular risk estimation
timeFrame: Baseline and 12 months
measure: Health-related quality of life
timeFrame: Baseline and 12 months
measure: Health-related quality of life
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: Baseline and 12 months
measure: Total cholesterol levels
timeFrame: Baseline and 12 months
measure: High-density lipoprotein (HDL-c) levels
timeFrame: Baseline and 12 months
measure: Low-density lipoprotein (LDL-c) levels
timeFrame: Baseline and 12 months
measure: Triglycerides levels
timeFrame: Baseline and 12 months
measure: Glucose levels
timeFrame: Baseline and 12 months
measure: Number of patients with smoking cessation
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
Study officials:
affiliation: Universidad de Granada
name: Elza Aparecida M Domingues, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Virgen de las Nieves
name: Miguel Angel Calleja Hernandez, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital Virgen de las Nieves
name: Monica Ferrit Martin, PhD
role: STUDY_DIRECTOR
References: