Pharmacotherapy Follow-up in Older HIV-infected Patients
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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Granada, Spanje
- Hospital Universitario Virgen de las Nieves
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Pharmaceutical care
Dader method.
Health education for lifestyle modification.
Improve adherence.
Resolution of negative outcome associated with medication.
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This is a quasi-experimental study and the same group will be evaluated before and after the follow up.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cardiovascular risk estimation
Tijdsspanne: Baseline and 12 months
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Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
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Cardiovascular risk estimation
Tijdsspanne: Baseline and 12 months
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Change in cardiovascular risk estimated by REGICOR equation will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
|
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Health-related quality of life
Tijdsspanne: Baseline and 12 months
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Change in health-related quality of life measured by SF-36 questionnaire will be evaluated after one year of Pharmaceutical Care.
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Baseline and 12 months
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Health-related quality of life
Tijdsspanne: Baseline and 12 months
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Change in health-related quality of life measured by MOS-HIV questionnaire will be evaluated after one year of Pharmaceutical Care.
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Baseline and 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Systolic and diastolic blood pressure
Tijdsspanne: Baseline and 12 months
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Change in systolic and diastolic blood pressure will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
|
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Total cholesterol levels
Tijdsspanne: Baseline and 12 months
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Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
|
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High-density lipoprotein (HDL-c) levels
Tijdsspanne: Baseline and 12 months
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Change in HDL-c will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
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Low-density lipoprotein (LDL-c) levels
Tijdsspanne: Baseline and 12 months
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Change in LDL-c will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
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Triglycerides levels
Tijdsspanne: Baseline and 12 months
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Change in triglycerides levels will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
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Glucose levels
Tijdsspanne: Baseline and 12 months
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Change in glucose levels will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
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Number of patients with smoking cessation
Tijdsspanne: Baseline and 12 months
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Patients that achieve smoking cessation after one year of Pharmaceutical Care
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Baseline and 12 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elza Aparecida M Domingues, MSc, Universidad de Granada
- Studie directeur: Miguel Angel Calleja Hernandez, PhD, University Hospital Virgen de las Nieves
- Studie directeur: Monica Ferrit Martin, PhD, University Hospital Virgen de las Nieves
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- University of Granada
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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