Effects of Remote Patient Monitoring on Heart Failure Management
Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
調査の概要
詳細な説明
Poor management of heart failure (HF) has added to the high costs and negative health outcomes from this chronic illness, including frequent hospitalization. HF patients require close monitoring to detect worsening health and to optimize their treatment. However, many patients visit their HF clinicians only once every few months, and perform minimal or no self-monitoring.
Remote patient monitoring is a potential tool to help clinicians and the patients better manage HF. A remote patient monitoring system (home monitoring of vital signs and symptoms) that has been developed with extensive clinician and patient input and testing, will be studied to determine its effects on HF management. Half of one hundred patients from the University Health Network Heart Failure Clinic will be randomly placed into the remote monitoring (RM) group and the other half will be in the control group. Patients in the RM group will monitor their weight, blood pressure, ECG, and symptoms at home for 6 months. This information will be automatically sent from the medical devices wirelessly through Bluetooth to a mobile phone, which will send the information to the data servers. Both clinicians and patients will have access to the data. Patients will get automated reminder telephone calls if they do not take the number of measurements prescribed by their doctors.
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
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Ontario
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Toronto、Ontario、カナダ、M5G 2C4
- University Health Network
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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:
- Clinical diagnosis of Heart Failure (NYHA Class II-IV)
- Out-patients attending the University Health Network Heart Failure Clinic
- English-speaking and able to read English
- 18 years old or over
Exclusion Criteria:
- Awaiting heart transplantation
- Not expected to survive over a year (as determined by their cardiologist)
- Unable to read text on a mobile phone due to vision disability
- Unable to self-care due to anxiety, depression, or decreased cognitive function
- Lack of manual dexterity to accurately press buttons on the mobile phone
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:支持療法
- 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:remote monitoring
group of patients that will be using the heart failure remote patient monitoring system in addition to the usual care they receive at the University Health Network Heart Failure Clinic
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remote monitoring of weight, blood pressure, ECG, and symptoms
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介入なし:control
group of patients provided with usual care at the University Health Network Heart Failure Clinic
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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 |
時間枠 |
---|---|
Brain Natriuretic Peptide values
時間枠:Baseline, 6 months
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Baseline, 6 months
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Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
時間枠:baseline, 6 months
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baseline, 6 months
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Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
時間枠:baseline, 6 months
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baseline, 6 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Number of hospitalizations and days in hospital
時間枠:6 months comparison between intervention and control groups
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6 months comparison between intervention and control groups
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Number of Emergency Department visits
時間枠:6 month comparison between intervention and control groups
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6 month comparison between intervention and control groups
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All cause mortality
時間枠:6 month comparison between intervention and control groups
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6 month comparison between intervention and control groups
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Number of Heart Failure Clinic visits
時間枠:6 month comparison between intervention and control groups
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6 month comparison between intervention and control groups
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協力者と研究者
捜査官
- 主任研究者:Heather J Ross, MD, MHSc、University Health Network, Toronto
出版物と役立つリンク
一般刊行物
- Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Developing healthcare rule-based expert systems: case study of a heart failure telemonitoring system. Int J Med Inform. 2012 Aug;81(8):556-65. doi: 10.1016/j.ijmedinf.2012.03.001. Epub 2012 Mar 31.
- Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909.
研究記録日
主要日程の研究
研究開始
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 (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。
心不全の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)