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Self-screening of Cardiovascular Risk (ACRISC)

2019年8月28日 更新者:Maria Grau、Parc de Salut Mar

Validity and Effectiveness of a Method for Self-screening of Cardiovascular Risk

The aims of this study are (1) to validate a self-screening method for cardiovascular (CV) risk that does not require the supervision of a health professional (including self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) From these data, the investigators will generate personalized recommendations based on the best available evidence. The investigators will also analyze whether this innovative approach improves adherence to preventive recommendations for cardiovascular and other chronic diseases.

調査の概要

詳細な説明

Primary prevention activities based on some admittedly blunt screening instruments such as cardiovascular (CV) risk functions must be addressed to the whole population, prioritizing certain sectors of the population. However, the main limitation of current risk screening procedures is related to the natural history of cardiovascular disease, whose expression depends on the cumulative exposure to cardiovascular risk factors throughout a person's lifetime. Early prevention of cardiovascular disease is key to reduce this cumulative risk, thereby reducing the incidence of cardiovascular events.

The objectives of this study are (1) to validate a self-screening method for cardiovascular risk that does not require the supervision of a health professional (including self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) From these data, the investigators will generate personalized recommendations based on the best available evidence. The investigators will also analyze whether this innovative approach improves adherence to preventive recommendations for cardiovascular and other chronic diseases.

Cardiovascular risk measured with the self-screening method will be compared with the gold standard (cardiovascular risk supervised by health professional). Participants will be randomly assigned to the intervention (communication of cardiovascular risk and recommendation of personalized preventive actions) or control groups (communication of cardiovascular risk). Subjects will be reexamined one year after recruitment for assessing adherence to the preventive recommendations in terms of improvement in the control of cardiovascular risk factors.

研究の種類

介入

入学 (実際)

960

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Girona、スペイン、17002
        • Unitat de Suport a la Recerca de Girona IDIAP Jordi Gol

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

35年~74年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Understand and accept the study's procedures and sign an informed consent form
  • Inhabitants of Girona (Gerona, Spain) and the metropolitan area

Exclusion Criteria:

  • History of cardiovascular disease
  • Individuals with terminal disease

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ふるい分け
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • 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:CV-screening-1 plus personalized
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
実験的:CV-screening-2 plus personalized
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
アクティブコンパレータ:CV-screening-1 plus standard
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Standard communication of the health exam results
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Standard communication of the health exam results
アクティブコンパレータ:CV-screening-2 plus standard
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results

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
Pre-post changes in blood lipid levels
時間枠:[Time frame: From baseline to 12 months after the intervention]
Pre-post changes in mean levels of blood lipid levels (total, HDL and LDL cholesterol). Blood samples will be obtained at baseline and 12 months after the intervention.
[Time frame: From baseline to 12 months after the intervention]

二次結果の測定

結果測定
メジャーの説明
時間枠
Pre-post changes in controlled blood lipid levels
時間枠:From baseline to 12 months after the intervention
Pre-post changes in the percentage of individuals with controlled blood lipid levels according to the most updated European Clinical Practice Guidelines (total, HDL and LDL cholesterol). Blood samples will be obtained at baseline and 12 months after the intervention.
From baseline to 12 months after the intervention
Pre-post changes in controlled blood pressure
時間枠:From baseline to 12 months after the intervention
Pre-post changes in the percentage of individuals with controlled systolic and diastolic blood pressure levels (140 and 90 mmHg, respectively). Measures will be obtained at baseline and 12 months after the intervention
From baseline to 12 months after the intervention
Pre-post changes in controlled body mass index
時間枠:From baseline to 12 months after the intervention
Pre-post changes in the percentage of individuals with body mass index below 25 kg/m2. Measures will be obtained at baseline and 12 months after the intervention.
From baseline to 12 months after the intervention
Pre-post differences in smoking status
時間枠:From baseline to 12 months after the intervention
Pre-post changes in the percentage of smokers. Smoking status will be assessed at baseline and 12 months after the intervention
From baseline to 12 months after the intervention
Mean difference between two methods of cardiovascular risk estimation
時間枠:From baseline to 30 minutes
Comparison of cardiovascular risk estimates by two methods (Screening of cardiovascular risk supervised by health professional (Gold Standard) - self-screening of cardiovascular risk). Measures with each method will be taken 30 minutes apart after a wash-out period
From baseline to 30 minutes
Pre-post changes in blood pressure
時間枠:From baseline to 12 months after the intervention
Pre-post changes in mean levels of systolic and diastolic blood pressure. Measures will be obtained at baseline and 12 months after the intervention.
From baseline to 12 months after the intervention
Pre-post changes in body mass index
時間枠:From baseline to 12 months after the intervention
Pre-post changes in mean levels of systolic and diastolic blood pressure. Measures will be obtained at baseline and 12 months after the intervention.
From baseline to 12 months after the intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Maria Grau, MD, PhD, MPH、IMIM
  • スタディディレクター:Jaume Marrugat, MD, PhD、IMIM

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年3月1日

一次修了 (実際)

2017年4月1日

研究の完了 (実際)

2018年4月1日

試験登録日

最初に提出

2015年2月20日

QC基準を満たした最初の提出物

2015年2月26日

最初の投稿 (見積もり)

2015年2月27日

学習記録の更新

投稿された最後の更新 (実際)

2019年8月29日

QC基準を満たした最後の更新が送信されました

2019年8月28日

最終確認日

2019年8月1日

詳しくは

本研究に関する用語

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。

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