Pharmacotherapy Follow-up in Older HIV-infected Patients

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763995
• Other study ID #: University of Granada
• Status: Completed
• Phase: N/A
• First received: April 27, 2016
• Last updated: May 3, 2016
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2016
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Pharmaceutical care
This is a quasi-experimental study and the same group will be evaluated before and after the follow up.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de las Nieves	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Elza Aparecida Machado Domingues

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular risk estimation	Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care	Baseline and 12 months	No
Primary	Cardiovascular risk estimation	Change in cardiovascular risk estimated by REGICOR equation will be evaluated after one year of Pharmaceutical Care	Baseline and 12 months	No
Primary	Health-related quality of life	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	No
Primary	Health-related quality of life	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	No
Secondary	Systolic and diastolic blood pressure	Change in systolic and diastolic blood pressure will be evaluated after one year of Pharmaceutical Care	Baseline and 12 months	No
Secondary	Total cholesterol levels	Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care	Baseline and 12 months	No
Secondary	High-density lipoprotein (HDL-c) levels	Change in HDL-c will be evaluated after one year of Pharmaceutical Care	Baseline and 12 months	No
Secondary	Low-density lipoprotein (LDL-c) levels	Change in LDL-c will be evaluated after one year of Pharmaceutical Care	Baseline and 12 months	No
Secondary	Triglycerides levels	Change in triglycerides levels will be evaluated after one year of Pharmaceutical Care	Baseline and 12 months	No
Secondary	Glucose levels	Change in glucose levels will be evaluated after one year of Pharmaceutical Care	Baseline and 12 months	No
Secondary	Number of patients with smoking cessation	Patients that achieve smoking cessation after one year of Pharmaceutical Care	Baseline and 12 months	No