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Health-circuit Evaluation as a Digital Support for the Management of Patients at Risk of Hospitalization (Health_Circuit)

2021年2月9日 更新者:Carmen Herranz、Hospital Clinic of Barcelona

Background - There is a high potential for hospitalization prevention through: (i) a greater continuity of care, achieved by facilitating collaborative work among professionals at different levels of care, and (ii) improving the self-efficacy of patients. For both objectives, the support of appropriate information and communication technologies is essential. The study raises the hypothesis that an industry 4.0 system, Health-Circuit, based on communication technologies and intelligent collaboration, will facilitate a greater continuity of care and an improvement in patients' self-efficacy.

Objective - Analysis of Health-Circuit's potential for improving the continuity of care and self-efficacy of chronic patients at risk of hospitalization.

Material and methods - Controlled, single-blinded, randomized trial by primary care teams, with a 2:1 intervention-control ratio. The first phase of the study (September-November 2019) will be carried out in 75 patients from the primary care area of Barcelona Esquerra under the influence of Hospital Clínic of Barcelona (CAPSBE, 110k inhabitants). In the intervention group, the patients, and the corresponding healthcare professionals, will communicate and collaborate though Health-Circuit, while the control group will receive conventional treatment. In a second phase (beginning December 2019), the study will be extended to the entire healthcare area of Barcelona Esquerra (AISBE, 520k inhabitants).

Expected results - From a clinical perspective, a reduction in the number of urgent face-to-face visits is expected at: (i) Hospital; (ii) Primary Care, or, (iii) Primary Care Emergency Centers, due to better continuity of care and greater self-efficacy of patients. However, the results sought in Phase I of the study will be, fundamentally: (i) the evaluation of the usability and acceptability of Health-Circuit for patients and professionals, and (ii) the analysis of the potential of the digital tool for the management of complex clinical processes with the help of intelligent bots. In phase II of the study, the central objectives will be (i) increase in the capacity to resolve events, and (ii) improvement of patients' self-efficacy.

調査の概要

詳細な説明

The present investigation develops in the framework of the EU project CONNECARE "Personalized Connected Care for Complex Chronic Patients (H2020 - BHC25 - 689802), whose registration number in the medical research ethics committee of Hospital Clínic of Barcelona is HCB / 2018/0803. CONNECARE assumes that (i) the improvement of the continuity of care, associated with facilitating collaborative work among professionals of different levels of care, and, (ii) the increase in patients' self-efficacy, results in an optimization of the management of chronic patients with the consequent decrease in unplanned consultations, whether at primary care or at the hospital. This necessarily leads to an increase in the resolving capacity of primary care teams and an increase in the prevention of hospitalizations.

Although the role of digital technologies, as an element of support for integrated care services, is well-demonstrated, at present, we still do not have adequate digital tools that provide adequate support for collaborative work between professionals and, in turn, encourage the empowerment for self-management of patients. We understand as such, technologies: (i) compliant with the General Data Protection Regulation (GDPR), (ii) interoperable with existing health information systems, and, that (iii) facilitate the adaptive and collaborative management of chronic patients.

The present study evaluates the potential of an industry 4.0 system, Health-Circuit, based on communication technologies and intelligent collaboration, for the improvement of the management of chronic patients, with the consequent increase of the resolving capacity of the community health teams. Health-Circuit allows patients and professionals to interact, bilaterally or in groups, from various information systems and devices, regardless of their physical location. The base technology platform, Circuit, is robust (TRL 9), located in the cloud (private, mixed or public) and complies with the General Data Protection Regulation (GDPR). Circuit allows multimedia corporate communication (chat, call, video-call, file exchange, etc.) between healthcare levels, increasing coordination among professionals with the consequent improvement of health outcomes. Its potential can be increased in the future with the use of intelligent Chatbots to guide patients and professionals through complex care processes, providing decision support for personalised service selection by means of enhanced health risk assessment and patient stratification.

研究の種類

介入

入学 (実際)

400

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

      • Barcelona、スペイン、08036
        • Hospital Clínic

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Participation in the SELFIE study.
  • Accepting to participate in the study and sign the consent.
  • In the intervention group, having a "smart phone" or "Tablet" that can support the use of the computer tool (versions of the operating systems Android or iOS compatible with the patient's application) and having an internet connection.

Exclusion Criteria:

  • Physical or psychological health problems that prevent the use of the tool and that the patient does not have the help of a caregiver.

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:ヘルスサービス研究
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Health-Circuit mobile application

The intervention contemplates. (i) management of unexpected events; and, (ii) empowering the patient to improve self-efficacy.

Users of the intervention arm will have the Health-Circuit mobile application, which will offer them the possibility of contacting the case managers to notify a health event at any time and that this can be resolved by their health professionals through Health -Circuit. The improvement of the patient's self-efficacy for the management of their health problems through the use of Health-Circuit is considered through the virtual visits of follow-up with the manager, the possibility of interacting with the manager and the consultation of the shared documents reminders of the action plan agreed with the patient.

Health-Circuit as a collaborative tool between professionals and patient and professionals
介入なし:Conventional treatment
Patients assigned to this group will follow conventional treatment. Once the three months have passed, we will contact you again to ask the pertinent questions.

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
Unplanned visits
時間枠:3 months
Number of unplanned primary care and hospital visits
3 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Service utilization measures
時間枠:3 months
number of primary care and hospital visits, number of remote resolutions and number of hospitalizations
3 months
Change in The Health Empowerment Scale
時間枠:3 months
The instrument retained 8 items, scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of health-related empowerment.
3 months
Change in the Fantastic Lifestyle questionnaire
時間枠:3 months
This questionnaire contains 25 closed items that you explore nine related physical, psychological and social categories or domains to the lifestyle. It presents three response options with a numerical value of 0 to 2 for each category, and they are graded using a Likert scale, with a score of 0 to 100 points. Taking as a cut-off point the average of the qualifications proposed by the authors of the instrument five levels of qualification stratify the behavior: (<39 points = danger exists, 40 to 59 points = bad, 60 to 69 points = regular , 70 to 84 points = good, 85 to 100 points = excellent) lifestyle. The lower the score, the greater the need for change.
3 months
Equipment failures
時間枠:3 months
Number of equipment failures according to blockage, breakage, acceleration or delay and unidentified failures
3 months
Software failures
時間枠:3 months
Number of software failures described as slowdown in execution, information delay, command rows or information not available
3 months
Errors in execution
時間枠:3 months
Number of errors in execution (wrong sequence action) described as omission, forward jump, backward jump, repetition, inversion or incorrect action
3 months
Number of errors due to the participant's temporary functions
時間枠:3 months
Number of errors due to the participant's temporary functions described as forgetfulness, incorrect memory, incomplete memory, random actions, stoppage of actions, suspended task, task not completed, objective forgotten or loss of orientation
3 months
Errors due to failures in the organization
時間枠:3 months
Number of errors due to failures in the organization described as anthropometric problems or inadequate interface
3 months
Number of participants in the study with respect to the total of potential participants
時間枠:3 months
Number of participants in the study with respect to the total of potential participants of: i. Patients ii. Professionals
3 months
Number of entries to the application (app) per patient
時間枠:3 months
Number of entries to the application (app) per patient
3 months
Number of contacts with clinical professionals responsible for managing the case
時間枠:3 months
Number of contacts with clinical professionals responsible for managing the case that will be contacted through the technological tool (mHealth manager): i. Number of total contacts. ii. Number of patients who have contacted
3 months
Number of video calls
時間枠:3 months
Number of video calls i. Number of total video calls. ii. Number of patients who have contacted via video call.
3 months
Number of patients who have accessed the conditions of use
時間枠:3 months
Number of patients who have accessed the conditions of use
3 months
Change in Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
時間枠:3 months
It consists of four questions selected from the domain Collaboration between care of the Nijmegen Continuity of Care Questionnaire. Scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of Collaboration between care providers from the patient's perspective.
3 months
Patient satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
時間枠:3 months
The Net Promoter Score is calculated based on the answers to a single question. The result is calculated by dividing the percentage of promoters (who have a score of 9-10) minus the percentage of detractors (who have a score of 0-6). The percentage of "liabilities" (which obtained a score of 7-8) is not included in the NPS calculation. The NPS varies between -100 and +100. A positive score is considered good. The three custom made general satisfaction question is scored on a 5-point Likert scale that ranges from 0 (poor) to 10 (Good).
3 months
Professional satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
時間枠:3 months
The Net Promoter Score is calculated based on the answers to a single question. The result is calculated by dividing the percentage of promoters (who have a score of 9-10) minus the percentage of detractors (who have a score of 0-6). The percentage of "liabilities" (which obtained a score of 7-8) is not included in the NPS calculation. The NPS varies between -100 and +100. A positive score is considered good. The three custom made general satisfaction question is scored on a 5-point Likert scale that ranges from 0 (poor) to 10 (Good).
3 months
Patient mHealth tool usability assessed by the System Usability Scale
時間枠:3 months
The System Usability Scale is a 10 item questionnaire with 5 response options. Scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of Collaboration between care providers from the patient's perspective.
3 months
Professional mHealth tool usability by the System Usability Scale
時間枠:3 months
The System Usability Scale is a 10 item questionnaire with 5 response options. Scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of Collaboration between care providers from the patient's perspective.
3 months
Patient mHealth experience
時間枠:3 months
Two open questions regarding negative and positive aspects of the use of the computer tool
3 months
Professional mHealth experience
時間枠:3 months
Two open questions regarding negative and positive aspects of the use of the computer tool
3 months
Number of clinical diagnoses in app users
時間枠:3 months
number of high priority clinical diagnoses in app users according to CIE10 in medical history
3 months
Degree of severity of the symptom
時間枠:3 months
Degree of severity of the symptom measured according to very mild, mild, neutral, severe or very serious
3 months
Duration of the symptom
時間枠:3 months
Duration of the symptom expressed in hours, days or weeks
3 months
Number of professionals that the manager has contacted through the app
時間枠:3 months
Number of professionals that the manager has contacted through the app
3 months
Number of interactions between professionals through the app
時間枠:3 months
Number of interactions between professionals through the app
3 months
Number of solutions provided only by the manager
時間枠:3 months
Number of solutions provided only by the manager regarding the number of total solutions
3 months
Number of solutions provided by the primary care professional
時間枠:3 months
Number of solutions provided by the primary care professional regarding the number of total solutions
3 months
Number of solutions that has been a virtual visit
時間枠:3 months
Number of solutions that has been a virtual visit with the primary care professional regarding the total number of solutions
3 months
Number of solutions that has been a classroom visit
時間枠:3 months
Number of solutions that has been a classroom visit with the primary care professional regarding the total number of solutions
3 months
Number of referrals to the emergency department regarding the total number of solutions
時間枠:3 months
Number of referrals to the emergency department regarding the total number of solutions
3 months

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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。

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)

2019年9月12日

一次修了 (実際)

2019年12月31日

研究の完了 (実際)

2020年4月10日

試験登録日

最初に提出

2019年7月22日

QC基準を満たした最初の提出物

2019年8月12日

最初の投稿 (実際)

2019年8月14日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月12日

QC基準を満たした最後の更新が送信されました

2021年2月9日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Health-Circuit Clinic

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?

いいえ

試験データ・資料

  1. Framework
    情報識別子:CONNECARE
    情報コメント:The ambition of the CONNECARE consortium is to co-design, develop, deploy, and evaluate a novel smart, adaptive integrated care system for chronic care management

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。

慢性疾患の臨床試験

  • Adelphi Values LLC
    Blueprint Medicines Corporation
    完了
    肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されました
    アメリカ

Health-Circuit mobile applicationの臨床試験

3
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