Pharmacotherapy Follow-up in Older HIV-infected Patients

May 8, 2016 updated by: Elza Aparecida Machado Domingues

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain
        • Hospital Universitario Virgen de las Nieves

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 12 months
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
Baseline and 12 months
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.
Baseline and 12 months
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.
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 12 months
Total cholesterol levels
Time Frame: Baseline and 12 months
Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care
Baseline and 12 months
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
Baseline and 12 months
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
Baseline and 12 months
Triglycerides levels
Time Frame: Baseline and 12 months
Change in triglycerides levels will be evaluated after one year of Pharmaceutical Care
Baseline and 12 months
Glucose levels
Time Frame: Baseline and 12 months
Change in glucose levels will be evaluated after one year of Pharmaceutical Care
Baseline and 12 months
Number of patients with smoking cessation
Time Frame: Baseline and 12 months
Patients that achieve smoking cessation after one year of Pharmaceutical Care
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elza Aparecida Machado Domingues

Investigators

  • Principal Investigator: Elza Aparecida M Domingues, MSc, Universidad de Granada
  • Study Director: Miguel Angel Calleja Hernandez, PhD, University Hospital Virgen de las Nieves
  • Study Director: Monica Ferrit Martin, PhD, University Hospital Virgen de las Nieves

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 8, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • University of Granada

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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