Pharmacotherapy Follow-up in Older HIV-infected Patients

NCT ID: NCT02763995

Last Updated: 2016-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-11-30

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 GironĂ­ 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.

Conditions

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Pharmaceutical care

Dader method. Health education for lifestyle modification. Improve adherence. Resolution of negative outcome associated with medication.

Group Type EXPERIMENTAL

Pharmaceutical care

Intervention Type BEHAVIORAL

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

Interventions

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Pharmaceutical care

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elza Aparecida Machado Domingues

OTHER

Sponsor Role lead

Responsible Party

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Elza Aparecida Machado Domingues

MSc

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Elza Aparecida M Domingues, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Miguel Angel Calleja Hernandez, PhD

Role: STUDY_DIRECTOR

University Hospital Virgen de las Nieves

Monica Ferrit Martin, PhD

Role: STUDY_DIRECTOR

University Hospital Virgen de las Nieves

Locations

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Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status

Countries

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Spain

Other Identifiers

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University of Granada

Identifier Type: -

Identifier Source: org_study_id

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