Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-22 @ 9:36 AM
Study NCT ID:
NCT02763995
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacotherapy Follow-up in Older HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010593', 'term': 'Pharmaceutical Services'}], 'ancestors': [{'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-08', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular risk estimation', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care'}, {'measure': 'Cardiovascular risk estimation', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in cardiovascular risk estimated by REGICOR equation will be evaluated after one year of Pharmaceutical Care'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in health-related quality of life measured by SF-36 questionnaire will be evaluated after one year of Pharmaceutical Care.'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in health-related quality of life measured by MOS-HIV questionnaire will be evaluated after one year of Pharmaceutical Care.'}], 'secondaryOutcomes': [{'measure': 'Systolic and diastolic blood pressure', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in systolic and diastolic blood pressure will be evaluated after one year of Pharmaceutical Care'}, {'measure': 'Total cholesterol levels', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care'}, {'measure': 'High-density lipoprotein (HDL-c) levels', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in HDL-c will be evaluated after one year of Pharmaceutical Care'}, {'measure': 'Low-density lipoprotein (LDL-c) levels', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in LDL-c will be evaluated after one year of Pharmaceutical Care'}, {'measure': 'Triglycerides levels', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in triglycerides levels will be evaluated after one year of Pharmaceutical Care'}, {'measure': 'Glucose levels', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in glucose levels will be evaluated after one year of Pharmaceutical Care'}, {'measure': 'Number of patients with smoking cessation', 'timeFrame': 'Baseline and 12 months', 'description': 'Patients that achieve smoking cessation after one year of Pharmaceutical Care'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'pharmaceutical care', 'older patients', 'cardiovascular risk', 'pharmacotherapy follow up'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': "Quasi-experimental clinical study, pre-post intervention, performed with one patient cohort.\n\nStudy 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.\n\nVariables will be obtained from patients' clinical histories, from dispensing records and through interviews with patients.\n\nMain variables:\n\n* cardiovascular risk estimated according to Systematic Coronary Risk Evaluation (SCORE) and Registre GironĂ del Cor (REGICOR) equations\n* HRQoL measured by the Short-Form 36-Item Health Survey (SF-36) and Medical Outcomes Study HIV Health Survey (MOS-HIV) questionnaires.\n\nOther variables: sociodemographic, clinical, pharmacological, related to CVR, related to NOM and to the interventions.\n\nInterventions 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients older than 50 years\n* in use of antiretroviral therapy\n* cardiovascular risk ≥2%, estimated by the SCORE equation\n* accept to participate in the research through the signature of a written informed consent\n\nExclusion Criteria:\n\n* patients with neurodegenerative deficit or HIV dementia\n* participants in clinical trials\n* non signature of a written informed consent'}, 'identificationModule': {'nctId': 'NCT02763995', 'briefTitle': 'Pharmacotherapy Follow-up in Older HIV-infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Pharmacotherapy Follow-up in Older HIV-infected Patients: Impact on Cardiovascular Risk and Quality of Life', 'orgStudyIdInfo': {'id': 'University of Granada'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmaceutical care', 'description': 'Dader method. Health education for lifestyle modification. Improve adherence. Resolution of negative outcome associated with medication.', 'interventionNames': ['Behavioral: Pharmaceutical care']}], 'interventions': [{'name': 'Pharmaceutical care', 'type': 'BEHAVIORAL', 'description': 'This is a quasi-experimental study and the same group will be evaluated before and after the follow up.', 'armGroupLabels': ['Pharmaceutical care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Elza Aparecida M Domingues, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}, {'name': 'Miguel Angel Calleja Hernandez, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Virgen de las Nieves'}, {'name': 'Monica Ferrit Martin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Virgen de las Nieves'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elza Aparecida Machado Domingues', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Elza Aparecida Machado Domingues', 'investigatorAffiliation': 'Universidad de Granada'}}}}