HIVNCT02763995
Pharmacotherapy Follow-up in Older HIV-infected Patients
A study testing Pharmaceutical care in people with HIV, run by Elza Aparecida Machado Domingues at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Pharmaceutical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with neurodegenerative deficit or HIV dementia
- participants in clinical trials
- non signature of a written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- HIV
- Being tested
- Pharmaceutical care
- Keywords
- HIV, pharmaceutical care, older patients, cardiovascular risk, pharmacotherapy follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careBehavioural
This is a quasi-experimental study and the same group will be evaluated before and after the follow up.
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical care | Experimental | Dader method. Health education for lifestyle modification. Improve adherence. Resolution of negative outcome associated with medication. Receives: Behavioral: Pharmaceutical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk estimation
Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care
Measured: Baseline and 12 months
Cardiovascular risk estimation
Change in cardiovascular risk estimated by REGICOR equation will be evaluated after one year of Pharmaceutical Care
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months
Secondary outcomes (7)
Systolic and diastolic blood pressure
Change in systolic and diastolic blood pressure will be evaluated after one year of Pharmaceutical Care
Measured: Baseline and 12 months
Total cholesterol levels
Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care
Measured: Baseline and 12 months
High-density lipoprotein (HDL-c) levels
Change in HDL-c will be evaluated after one year of Pharmaceutical Care
Measured: Baseline and 12 months
Low-density lipoprotein (LDL-c) levels
Change in LDL-c will be evaluated after one year of Pharmaceutical Care
Measured: Baseline and 12 months
Triglycerides levels
Change in triglycerides levels will be evaluated after one year of Pharmaceutical Care
Measured: Baseline and 12 months
Glucose levels
Change in glucose levels will be evaluated after one year of Pharmaceutical Care
Measured: Baseline and 12 months
Number of patients with smoking cessation
Patients that achieve smoking cessation after one year of Pharmaceutical Care
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elza Aparecida Machado Domingues
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elza Aparecida Machado Domingues, Universidad de Granada
- Investigators
- Elza Aparecida M Domingues, MSc, Principal investigator, Universidad de GranadaMiguel Angel Calleja Hernandez, PhD, Study director, University Hospital Virgen de las NievesMonica Ferrit Martin, PhD, Study director, University Hospital Virgen de las Nieves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763995
- Sponsor's protocol ID
- University of Granada
- Status last verified
- May 2016
- First submitted
- 27 Apr 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacotherapy Follow-up in Older HIV-infected Patients: Impact on Cardiovascular Risk and Quality of Life
- ClinicalTrials.gov ID
- NCT02763995
- Acronym / sponsor ID
- University of Granada
- Conditions
- HIV
- Keywords
- HIV, pharmaceutical care, older patients, cardiovascular risk, pharmacotherapy follow up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Elza Aparecida Machado DominguesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical care | Experimental | Behavioral: Pharmaceutical careDader method. Health education for lifestyle modification. Improve adherence. Resolution of negative outcome associated with medication. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- patients with neurodegenerative deficit or HIV dementia
- participants in clinical trials
- non signature of a written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical careThis is a quasi-experimental study and the same group will be evaluated before and after the follow up. | Behavioural | Pharmaceutical care |
Primary outcome
Cardiovascular risk estimation
Time frame: Baseline and 12 months
Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care
Cardiovascular risk estimation
Time frame: Baseline and 12 months
Change in cardiovascular risk estimated by REGICOR equation will be evaluated after one year of Pharmaceutical Care
Health-related quality of life
Time frame: 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.
Health-related quality of life
Time frame: Baseline and 12 months
Change in health-related quality of life measured by MOS-HIV questionnaire will be evaluated after one year of Pharmaceutical Care.
7 secondary outcomes
Systolic and diastolic blood pressure
Time frame: Baseline and 12 months
Total cholesterol levels
Time frame: Baseline and 12 months
High-density lipoprotein (HDL-c) levels
Time frame: Baseline and 12 months
Low-density lipoprotein (LDL-c) levels
Time frame: Baseline and 12 months
Triglycerides levels
Time frame: Baseline and 12 months
Glucose levels
Time frame: Baseline and 12 months
Number of patients with smoking cessation
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elza Aparecida M Domingues, MSc principal investigator
Universidad de Granada
Miguel Angel Calleja Hernandez, PhD study director
University Hospital Virgen de las Nieves
Monica Ferrit Martin, PhD study director
University Hospital Virgen de las Nieves
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care in people with HIV, run by Elza Aparecida Machado Domingues at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular risk estimation (time frame: Baseline and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2016.