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)
Panoramica dello studio
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Odense, Danimarca, 5000
- Odense University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Nessun intervento: Conventional
Treatment as usual
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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The number of readmissions
Lasso di tempo: at 26 weeks after discharge
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at 26 weeks after discharge
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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The mortality rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: at 26 weeks after discharge
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at 26 weeks after discharge
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The number of days readmitted
Lasso di tempo: 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
Lasso di tempo: days 26 weeks after discharge
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days 26 weeks after discharge
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Anne Dichmann Sorknaes, PhD student, University of Southern Denmark
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Completamento primario (Effettivo)
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Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UNRS-20100030-2
Informazioni su farmaci e dispositivi, documenti di studio
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