Impact of the Pharmaceutical Care on the Quality of Life in Patients With Chagas Heart Disease (ChagasCare)
Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial
The investigators hypothesize that pharmaceutical care may constitute an important tool for the clinical management of these patients by improving their compliance to their treatment with consequent improvement in their quality of life by minimizing symptoms, and decreasing the number of hospital admissions and adverse drug reactions. Therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with Chagas heart disease complicated by heart failure.
Study Type: Interventional
Study Design: A total of 88 patients will be randomly assigned into two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care. Both groups will be subjected to a follow-up period of 12 months. The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes include drug-related problems and exercise tolerance measured by the standard six-minute walk test.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Rio de Janeiro、ブラジル、21040360
- 募集
- Evandro Chagas Clinical Research Institute
-
コンタクト：
- Gilberto M Sperandio da Silva, pharmaceutist
- 電話番号：552138659648
- メール：gilbertomarcelo@gmail.com
-
主任研究者：
- Gilberto M Sperandio da Silva, pharmaceutist
-
-
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:
- The proposed clinical trial will be conducted in volunteers with Chagas disease complicated by heart failure.
- Subjects will include adults, men and women, racial or ethnic minorities.
- Diagnosed by two distinct Chagas serology tests (indirect immunofluorescence and enzyme linked immunosorbent assay
Exclusion Criteria:
- Patients with any of comorbidities that significantly affect the cardiac performance, such as coronary artery disease, moderate or severe heart valvular disease, left ventricular (LV) hypertrophy, congenital heart disease, or that limit their survival, such as malignant tumors and HIV, will be excluded from the study.
- Patients will be also be excluded in case of failure to give informed consent, inability to perform 6 minute- walk test, significant cognitive impairment, or pregnancy.
- Individuals who are participating in others intervention trials will also be excluded.
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：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Standard Care
(1) group who will receive standard care
|
These patients will only receive standard care, with out follow-up by the pharmacist
|
|
他の：Standard Care and Pharmaceutical Care
(2) group who will receive standard care and pharmaceutical care
|
Pharmaceutical care is the direct interaction between the pharmacist and the drug's users in order to improve the therapeutic compliance among outpatients and promote adequate pharmacotherapeutic 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 |
|---|---|---|
|
Quality of life.
時間枠：12 months
|
The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire.
Evaluation of patient quality of life during follow up of two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care.
|
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence and types of drug-related problems
時間枠：12 months
|
To evaluate the drug-related problems based on the classification of the Brazilian Pharmaceutical Care Consensus.
Evaluation of drug-related problems during follow up of two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care.
|
12 months
|
|
Physical functional capacity.
時間枠：12 months
|
All patients will have their physical functional capacity measured by the 6 minute-walk test (The patients will split in two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care).
The test will be performed at the beginning of protocol and after 12 months of follow-up.
|
12 months
|
協力者と研究者
協力者
捜査官
- 主任研究者：Gilberto M Silva, pharmaceutical、Evandro Chagas Clinical Research Institute
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。