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Pharmacotherapy Follow-up in Older HIV-infected Patients

E

Elza Aparecida Machado Domingues

Status

Completed

Conditions

HIV

Treatments

Behavioral: Pharmaceutical care

Study type

Interventional

Funder types

Other

Identifiers

NCT02763995
University of Granada

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

42 participants in 1 patient group

Pharmaceutical care
Experimental group
Description:
Dader method. Health education for lifestyle modification. Improve adherence. Resolution of negative outcome associated with medication.
Treatment:
Behavioral: Pharmaceutical care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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