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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Granada, 스페인
- Hospital Universitario Virgen de las Nieves
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cardiovascular risk estimation
기간: Baseline and 12 months
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Change in cardiovascular risk estimated by SCORE equation will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
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Cardiovascular risk estimation
기간: Baseline and 12 months
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Change in cardiovascular risk estimated by REGICOR equation will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
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Health-related quality of life
기간: Baseline and 12 months
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Change in health-related quality of life measured by SF-36 questionnaire will be evaluated after one year of Pharmaceutical Care.
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Baseline and 12 months
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Health-related quality of life
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Systolic and diastolic blood pressure
기간: Baseline and 12 months
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Change in systolic and diastolic blood pressure will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
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Total cholesterol levels
기간: Baseline and 12 months
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Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
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High-density lipoprotein (HDL-c) levels
기간: Baseline and 12 months
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Change in HDL-c will be evaluated after one year of Pharmaceutical Care
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Baseline and 12 months
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Low-density lipoprotein (LDL-c) levels
기간: Baseline and 12 months
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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
기간: 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
기간: 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
기간: Baseline and 12 months
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Patients that achieve smoking cessation after one year of Pharmaceutical Care
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Baseline and 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Elza Aparecida M Domingues, MSc, Universidad de Granada
- 연구 책임자: Miguel Angel Calleja Hernandez, PhD, University Hospital Virgen de las Nieves
- 연구 책임자: Monica Ferrit Martin, PhD, University Hospital Virgen de las Nieves
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- University of Granada
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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