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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Granada, Espagne
- Hospital Universitario Virgen de las Nieves
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cardiovascular risk estimation
Délai: 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
|
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Cardiovascular risk estimation
Délai: 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
Délai: 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
|
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Health-related quality of life
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Systolic and diastolic blood pressure
Délai: 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
Délai: 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
Délai: Baseline and 12 months
|
Change in HDL-c will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
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Low-density lipoprotein (LDL-c) levels
Délai: Baseline and 12 months
|
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
Délai: 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
Délai: Baseline and 12 months
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Change in glucose levels will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
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Number of patients with smoking cessation
Délai: Baseline and 12 months
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Patients that achieve smoking cessation after one year of Pharmaceutical Care
|
Baseline and 12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Elza Aparecida M Domingues, MSc, Universidad de Granada
- Directeur d'études: Miguel Angel Calleja Hernandez, PhD, University Hospital Virgen de las Nieves
- Directeur d'études: Monica Ferrit Martin, PhD, University Hospital Virgen de las Nieves
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- University of Granada
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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