Randomised Trial of Telehealth Consultations for Nursing Care of Chronic Obstructive Pulmonary Disease (COPD) Patients
Effectiveness of Nurse Lead Telehealth Consultations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
調査の概要
詳細な説明
COPD is among the most common reasons for illness and fatality in adults worldwide, and it is expected that this trend will escalate radically by 2020 (1). Approximately 29% of patients admitted to Hospital with exacerbation will be readmitted within the first month (2), and after one year 46% of patients will have been readmitted on one or more occasions due to exacerbation (3).
Therefore, trials have been carried out using different forms of digitally supported distance health interventions (telehealth nurse consultations) (4) of patients with COPD with a view to reducing the number of readmissions in a reliable way, measured in relation to mortality. Thus in these trials there are a certain indication that use of telehealth nurse consultations of patients with COPD is a treatment initiative that reliably can reduce the number of COPD patients readmitted with exacerbation.
The number of randomized telehealth studies are however few (4;5), and there is a lack of documentation of the effect of telehealth monitoring.
Therefore, a large randomized telehealth study with a clear set up was necessary.
This study is a randomized multicenter trial that will take place at the acute admissions department and lung department at Odense University Hospital,Denmark
We hypothesized that in a period of 26 weeks:
- The total number of readmissions can be reduced with 14%
- The time to the first readmission will be prolonged
- The number of readmissions with exacerbation can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
- The total number of readmission days can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
- The total number of readmission days with exacerbation can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
- The mortality rate will remain unchanged after the telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
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
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Odense、デンマーク、5000
- Odense University Hospital
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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:
- Chronic obstructive pulmonary disease (COPD) verified by spirometry.
- Exacerbation in COPD, defined as increased need for medicine, and increased dyspnea or increased expectorate or increased coughing.
- > or 40 years old
- Living on Funen and islands
- Signed informed consent.
Exclusion criteria:
- Not able to communicate via telephone and/or computer screen
- Previously received "The COPD suitcase", or participated in this protocol
- Systolic BT is <100 mm Hg
- Saturation < 90
- Thorax x-ray shows signs of malignant changes or lobar pneumonia
- Diagnosed with cancer or recurrence of cancer within the last five years
- Admitted with septic shock, acute myocardial infarction or other serious medical condition (for example renal disease)
- Diagnosed with heart failure (EF < 30%)
- Refused to participate
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：処理
- 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 |
|---|---|
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実験的：Telehealth consultation
Telehealth nurse consultation plus treatment as usual
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The consultations are structured as outpatient sessions immediately after discharge. The content of the education deals with the regular treatment, prevention of exacerbation and how to live with the illness. The aim of the counseling is to increase the patient's empowerment and competence to take action. The patients have the consultations for 7 days followed by a telephone call. Each session is organized and individualised according to the patient's wishes and needs for education and counselling. The equipment consists of a computer with web camera, microphone and measurement equipment. A button to contact to the nurse at the hospital, an alarm button and a volume button. The results are transferred to the hospital by a secure internet line.
他の名前：
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介入なし：Conventional
Treatment as usual
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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 |
|---|---|
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The number of readmissions
時間枠：at 26 weeks after discharge
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at 26 weeks after discharge
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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The mortality rate
時間枠：at 26 weeks weeks after discharge
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at 26 weeks weeks after discharge
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The duration to the first readmission
時間枠：at 26 weeks after discharge
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at 26 weeks after discharge
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The number of hospital readmissions with exacerbation
時間枠：at 26 weeks after discharge
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at 26 weeks after discharge
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The number of days readmitted
時間枠：days 26 weeks after discharge
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days 26 weeks after discharge
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The number of days readmitted with exacerbation
時間枠：days 26 weeks after discharge
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days 26 weeks after discharge
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協力者と研究者
捜査官
- 主任研究者：Anne Dichmann Sorknaes, PhD student、University of Southern Denmark
出版物と役立つリンク
一般刊行物
- Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet. 1997 May 24;349(9064):1498-504. doi: 10.1016/S0140-6736(96)07492-2.
- (2) Sundhedsstyrelsen. Genindlæggelser af ældre i Danmark 2008 - Nye tal fra Sundhedsstyrelsen. 1060. Ref Type: Internet Communication.
- Eriksen N, Hansen EF, Munch EP, Rasmussen FV, Vestbo J. [Chronic obstructive pulmonary disease. Admission, course and prognosis]. Ugeskr Laeger. 2003 Sep 8;165(37):3499-502. Danish.
- Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.
- Finkelstein SM, Speedie SM, Potthoff S. Home telehealth improves clinical outcomes at lower cost for home healthcare. Telemed J E Health. 2006 Apr;12(2):128-36. doi: 10.1089/tmj.2006.12.128.
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
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