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.
Studieoversikt
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Granada, Spania
- Hospital Universitario Virgen de las Nieves
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Pharmaceutical care
Dader method.
Health education for lifestyle modification.
Improve adherence.
Resolution of negative outcome associated with medication.
|
This is a quasi-experimental study and the same group will be evaluated before and after the follow up.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiovascular risk estimation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Baseline and 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Systolic and diastolic blood pressure
Tidsramme: 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
Tidsramme: Baseline and 12 months
|
Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
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High-density lipoprotein (HDL-c) levels
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and 12 months
|
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
Tidsramme: 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
Tidsramme: Baseline and 12 months
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Patients that achieve smoking cessation after one year of Pharmaceutical Care
|
Baseline and 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Elza Aparecida M Domingues, MSc, Universidad de Granada
- Studieleder: Miguel Angel Calleja Hernandez, PhD, University Hospital Virgen de las Nieves
- Studieleder: Monica Ferrit Martin, PhD, University Hospital Virgen de las Nieves
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- University of Granada
Plan for individuelle deltakerdata (IPD)
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