Randomised Trial of Telehealth Consultations for Nursing Care of Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT ID: NCT01178879
Last Updated: 2013-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
266 participants
INTERVENTIONAL
2010-05-31
2012-02-29
Brief Summary
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Detailed Description
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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:
1. The total number of readmissions can be reduced with 14%
2. The time to the first readmission will be prolonged
3. The number of readmissions with exacerbation can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
4. The total number of readmission days can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
5. 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
6. The mortality rate will remain unchanged after the telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Telehealth consultation
Telehealth nurse consultation plus treatment as usual
Telehealth consultation
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.
Conventional
Treatment as usual
No interventions assigned to this group
Interventions
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Telehealth consultation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Sygekassernes Helsefond
OTHER
Danish Nurses Organisation
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Birte Oestergaard
Associate professor
Principal Investigators
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Anne Dichmann Sorknaes, PhD student
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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References
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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.
Other Identifiers
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UNRS-20100030-2
Identifier Type: -
Identifier Source: org_study_id