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NCT Number: NCT02763995

Pharmacotherapy Follow-up in Older HIV-infected Patients

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.

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Key information

Conditions

HIV

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen de las Nieves

Granada, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmaceutical Care

Behavioral

This is a quasi-experimental study and the same group will be evaluated before and after the follow up.

Primary outcomes

  1. Cardiovascular risk estimation

    Time frame: Baseline and 12 months

    Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care

  2. Cardiovascular risk estimation

    Time frame: Baseline and 12 months

    Change in cardiovascular risk estimated by REGICOR equation will be evaluated after one year of Pharmaceutical Care

  3. Health-related quality of life

    Time frame: 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.

  4. Health-related quality of life

    Time frame: Baseline and 12 months

    Change in health-related quality of life measured by MOS-HIV questionnaire will be evaluated after one year of Pharmaceutical Care.

Secondary outcomes

  1. Systolic and diastolic blood pressure

    Time frame: Baseline and 12 months

    Change in systolic and diastolic blood pressure will be evaluated after one year of Pharmaceutical Care

  2. Total cholesterol levels

    Time frame: Baseline and 12 months

    Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care

  3. High-density lipoprotein (HDL-c) levels

    Time frame: Baseline and 12 months

    Change in HDL-c will be evaluated after one year of Pharmaceutical Care

  4. Low-density lipoprotein (LDL-c) levels

    Time frame: Baseline and 12 months

    Change in LDL-c will be evaluated after one year of Pharmaceutical Care

  5. Triglycerides levels

    Time frame: Baseline and 12 months

    Change in triglycerides levels will be evaluated after one year of Pharmaceutical Care

  6. Glucose levels

    Time frame: Baseline and 12 months

    Change in glucose levels will be evaluated after one year of Pharmaceutical Care

  7. Number of patients with smoking cessation

    Time frame: Baseline and 12 months

    Patients that achieve smoking cessation after one year of Pharmaceutical Care

Sponsors and collaborators

Lead sponsor

Elza Aparecida Machado Domingues

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 5, 2016
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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