NCT02763995

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

1.6 years

First QC Date

April 27, 2016

Last Update Submit

May 8, 2016

Conditions

HIV

Keywords

HIVpharmaceutical careolder patientscardiovascular riskpharmacotherapy follow up

Outcome Measures

Primary Outcomes (4)

  • Cardiovascular risk estimation

    Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care

    Baseline and 12 months

  • Cardiovascular risk estimation

    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

    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

    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

Secondary Outcomes (7)

  • Systolic and diastolic blood pressure

    Baseline and 12 months

  • Total cholesterol levels

    Baseline and 12 months

  • High-density lipoprotein (HDL-c) levels

    Baseline and 12 months

  • Low-density lipoprotein (LDL-c) levels

    Baseline and 12 months

  • Triglycerides levels

    Baseline and 12 months

  • +2 more secondary outcomes

Study Arms (1)

Pharmaceutical care

EXPERIMENTAL

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

Behavioral: Pharmaceutical care

Interventions

Pharmaceutical careBEHAVIORAL

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

Pharmaceutical care

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients with neurodegenerative deficit or HIV dementia
  • participants in clinical trials
  • non signature of a written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

MeSH Terms

Interventions

Pharmaceutical Services

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Elza Aparecida M Domingues, MSc

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

  • Miguel Angel Calleja Hernandez, PhD

    University Hospital Virgen de las Nieves

    STUDY DIRECTOR

  • Monica Ferrit Martin, PhD

    University Hospital Virgen de las Nieves

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 5, 2016

Study Start

April 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 10, 2016

Record last verified: 2016-05

Locations

ES(1)