EHRA-PATHS: 新しいケア経路の臨床的および健康経済的評価 (EHRA-PATHS)
EHRA-PATHS: 学際的で患者中心の体系的なケア経路による高齢心房細動患者のマルチモビディティへの対処 - 新しいケア経路の臨床的および健康経済的評価
In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.
調査の概要
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
-
-
-
Groningen、オランダ
- University Medical Center Groningen
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-
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:
- Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent)
- ≥65 years of age
- Willing and able to participate and to attend the scheduled follow-up visits.
Exclusion Criteria:
- Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.)
- Life expectancy of less than 1 year
- Participation in another clinical study (registry studies not included)
- Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)
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
- 主な目的：診断
- 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：New care program
The health care provider will use the EHRA-PATHS' newly developed care pathways to assess whether there is an indication for presence of risk factors and comorbidities. If this is the case, the care pathways will show possible next steps for confirming the presence of these risk factors and comorbidities. If confirmed, treatment according to the current guidelines should be initiated. Since this leads to an individualized management plan, procedures can differ between patients and will also depend on local processes. |
Newly developed care pathways integrated into a care-management software tool |
|
介入なし：Routine clinical care
The health care provider follows current clinical practice with regards to history taking, physical examination etc. |
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 |
|---|---|---|
|
Identification and management of risk factors and comorbidities
時間枠：6 months
|
The number of risk factors and comorbidities that are identified and for which treatment is initiated during base mapping and at the end of the randomized controlled trial. |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
AF symptom burden
時間枠：6 months
|
Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire |
6 months
|
|
Quality of life (QoL)
時間枠：6 months
|
Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire |
6 months
|
|
Referrals to other disciplines
時間枠：6 months
|
The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred. |
6 months
|
|
Patient and health care provider satisfaction
時間枠：6 months
|
Measured with a patient and health care provider (HCP) satisfaction questionnaire |
6 months
|
|
Healthcare resource use/costs
時間枠：6 months
|
Measured with the iMedical Consumption Questionnaire (iMCQ) |
6 months
|
|
HRQoL/utility
時間枠：6 months
|
Measured with the EQ-5D-5L questionnaire (iMCQ) |
6 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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。