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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Granada、スペイン
- Hospital Universitario Virgen de las Nieves
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiovascular risk estimation
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
Baseline and 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Systolic and diastolic blood pressure
時間枠：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
時間枠：Baseline and 12 months
|
Change in total cholesterol levels will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
|
High-density lipoprotein (HDL-c) levels
時間枠：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
時間枠：Baseline and 12 months
|
Change in LDL-c will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
|
Triglycerides levels
時間枠：Baseline and 12 months
|
Change in triglycerides levels will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
|
Glucose levels
時間枠：Baseline and 12 months
|
Change in glucose levels will be evaluated after one year of Pharmaceutical Care
|
Baseline and 12 months
|
|
Number of patients with smoking cessation
時間枠：Baseline and 12 months
|
Patients that achieve smoking cessation after one year of Pharmaceutical Care
|
Baseline and 12 months
|
協力者と研究者
捜査官
- 主任研究者：Elza Aparecida M Domingues, MSc、Universidad de Granada
- スタディディレクター：Miguel Angel Calleja Hernandez, PhD、University Hospital Virgen de las Nieves
- スタディディレクター：Monica Ferrit Martin, PhD、University Hospital Virgen de las Nieves
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- University of Granada
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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