単群、多施設共同研究：ATTR-CM患者向けに構成されたデジタル遠隔モニタリングツールの受容性と実現可能性を評価する：ACO-Monitor (ACO-MONITOR)
トランスサイレチンアミロイド心筋症（ATTR-CM）患者におけるデジタル遠隔モニタリングツール（Luscii）の受容性と実用性をより詳しく学ぶための観察研究
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a heart condition caused by a protein called transthyretin (TTR) building up as amyloid in the heart muscle. This build-up makes the heart stiff and can lead to symptoms of heart failure, such as difficulty breathing, tiredness, swelling in the legs, and reduced ability to be physically active. ATTR-CM occurs in two forms: a hereditary (variant) type caused by changes in genes, and a wild-type form that usually develops with aging.
People living with ATTR-CM are usually cared for at specialist centers, which may require them to travel long distances for appointments. Because of this, visits may be infrequent, and sometimes people only see their doctor once a year. This can make it harder to notice if the disease is getting worse or if there are problems with following their treatment plan. As a result, important changes in health may go unnoticed for several months, which can be risky.
Remote monitoring offers a way for people living with ATTR-CM and their healthcare professionals to stay connected between clinic visits. Recent studies have shown that remote monitoring can help by making it easier to share health information, spot problems earlier, and support people to follow their treatment plans. This can lead to fewer hospital visits and better health outcomes.
Luscii is a digital remote monitoring tool designed to help people living with ATTR-CM and their healthcare professionals stay connected between clinic visits. Luscii has two main parts: Luscii contact, a smartphone app that allows secure messaging and video calls, and Luscii vitals, a clinical software system that organizes health data and can alert the healthcare team if there are changes that need attention. Luscii vitals is a CE-marked medical device used within its approved purpose and does not replace a doctor's judgement.
By making it easier to communicate and share information, Luscii aims to support earlier detection of problems, better management of ATTR-CM, and a more positive experience for people living with this condition.
The main purpose of this observational study, called ACO-MONITOR, is to learn how acceptable and practical Luscii is for people living with ATTR-CM and their healthcare professionals. The study will take place in Austria, Germany, and Italy at three specialist centers. About 60 adults with a diagnosis of hereditary or wild-type ATTR-CM will be invited to take part. There will be no treatments given as part of this study. Instead, participants will use the Luscii app and devices at home to track their health and share information with their healthcare professionals. The study team will provide training on how to use Luscii and will help participants get started.
The study team will look at:
- How quickly and how often participants and healthcare professionals use Luscii
- How long Luscii is used by each person
- How many times participants use Luscii after being reminded
- How easy Luscii is to use, based on questionnaires for both participants and healthcare professionals
The study will last about 18 months in total, including a 6-month period to invite participants and a 12-month follow-up period. During the study, the study team will:
- Support participants in using Luscii to share health information from home
- Monitor how often and how easily Luscii is used
- Ask participants and healthcare professionals about their experiences using Luscii, including what worked well and what could be improved
- Record any problems or technical issues with using Luscii By collecting this information, the researchers hope to learn if Luscii can help improve communication, support earlier detection of health problems, and make it easier for people living with ATTR-CM to manage their condition between clinic visits.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Bayer Clinical Trials Contact
- 電話番号：(+)1-888-84 22937
- メール：clinical-trials-contact@bayer.com
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
サンプリング方法
調査対象母集団
Eligible participants will be invited by their treating physician and, after providing informed consent, will be observed for approx. 12 months. Patients with an established diagnosis of either wild-type or variant ATTR-CM can be enrolled. Evidence of assessment of all eligibility criteria by the physician or a delegate, as well as enrolment of a participant in the study should be documented in the participant medical records. Medical professionals who are directly involved in the participants' treatment and who have access to and will review the Luscii-captured data for routine care are asked to complete the study-specific questionnaires/forms.
説明
Inclusion Criteria:
For patients:
- Adult (≥18 years at the date of signing the informed consent form (ICF)).
- Diagnosis of either wild-type or variant ATTR-CM.
- Treatment with a drug approved for ATTR-CM, including newly prescribed therapy at the initial visit.
- Signed ICF.
- Access to and basic ability to use a personal smartphone with internet connectivity sufficient to install and operate the Luscii contact application.
For medical professionals:
- Directly involved in the treatment or clinical management of the enrolled ATTR-CM participants and having access to and reviewing the Luscii-captured data for routine care.
- Agreement to ICF within the EDC system for the purpose of using Luscii or to complete the HCP Experience Questionnaire.
Exclusion Criteria:
For patients:
- Participation in an investigational program with interventions outside of routine clinical practice.
- Patients who are unable to provide consent, including those whose consent would need to be given by a legal representative.
For medical professionals:
- Any current affiliation with Luscii, Bayer, or any of their affiliates.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Wild-type or variant ATTR-CM participants
Participants will be enrolled after the decision to initiate the use of the digital remote monitoring tool, Luscii, as per standard use. |
The Luscii tool (CE class IIa certification) will be utilized for remote monitoring of health data specific to ATTR-CM patients. Following the observational nature of the study, no additional interventions will be implemented beyond the standard use of the Luscii tool. Participants will use the Luscii tool continuously throughout the observational period, which is approximately 12 months. |
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 |
|---|---|---|
|
Acceptance of Luscii among medical professionals
時間枠：At baseline (initial visit), at 6 months and at 12 months
|
Defined as their willingness to adopt and engage with the ATTR-CM-specific configuration of Luscii vitals and Luscii contact throughout the study period. |
At baseline (initial visit), at 6 months and at 12 months
|
|
Acceptance of Luscii among participants with ATTR-CM
時間枠：At baseline (initial visit), at 6 months and at 12 months
|
Defined as their willingness to adopt and engage with the ATTR-CM-specific configuration of Luscii contact throughout the observational period. |
At baseline (initial visit), at 6 months and at 12 months
|
|
Feasibility of Luscii for medical professionals
時間枠：At baseline (initial visit), at 6 months and at 12 months
|
Defined as the practicality of implementing the tool in real-world ATTR-CM care throughout the study period. |
At baseline (initial visit), at 6 months and at 12 months
|
|
Feasibility of Luscii for participants with ATTR-CM
時間枠：At baseline (initial visit), at 6 months and at 12 months
|
Defined as the practicality of using the tool in real-world settings throughout the observational period. |
At baseline (initial visit), at 6 months and at 12 months
|
|
Self-reported acceptance and feasibility of the ATTR-CM-specific Luscii configuration among participants
時間枠：At baseline (initial visit), at 6 months and at 12 months
|
Measured by the Patient Experience Questionnaire |
At baseline (initial visit), at 6 months and at 12 months
|
|
Self-reported acceptance and feasibility of the ATTR-CM-specific Luscii configuration among medical professionals
時間枠：At baseline (initial visit), at 6 months and at 12 months
|
Measured by the Healthcare Professional (HCP) Experience Questionnaire |
At baseline (initial visit), at 6 months and at 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
スクリーニングに失敗した患者の数
時間枠：ベースライン（初回来院時）
|
ベースライン（初回来院時）
|
|
|
スクリーニング失敗理由
時間枠：ベースライン時（初回訪問）
|
ベースライン時（初回訪問）
|
|
|
Participant demographic characteristics: age
時間枠：At baseline (initial visit)
|
Demographic characteristics of participants with ATTR-CM who are willing to use a digital remote tool at baseline (initial visit) |
At baseline (initial visit)
|
|
Participant demographic characteristics: sex
時間枠：At baseline (initial visit)
|
Demographic characteristics of participants with ATTR-CM who are willing to use a digital remote tool at baseline |
At baseline (initial visit)
|
|
Participant demographic characteristics: race
時間枠：At baseline (initial visit)
|
Demographic characteristics of participants with ATTR-CM who are willing to use a digital remote tool at baseline |
At baseline (initial visit)
|
|
Clinical characteristics: National Amyloidosis Centre (NAC) Stage
時間枠：At baseline (initial visit)
|
Categorization of participants according to the NAC Stage into stages I, II, or III, with stage III indicating a higher risk of mortality |
At baseline (initial visit)
|
|
Clinical characteristics: relevant comorbidities
時間枠：At baseline (initial visit)
|
ATTR-CM relevant comorbidities |
At baseline (initial visit)
|
|
Treatment patterns with Acoramidis: ATTR-CM prior medications
時間枠：At baseline (initial visit)
|
Concomitant medications administered within the past 12 months before initial visit |
At baseline (initial visit)
|
|
Treatment patterns with Acoramidis: ATTR-CM concomitant medications
時間枠：At baseline (initial visit)
|
Previously administered ATTR-CM related medications within the past 12 months before initial visit |
At baseline (initial visit)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- 23127
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?
IPD プランの説明
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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