Randomised Trial of Telehealth Consultations for Nursing Care of Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether telehealth nursing consultations of chronic obstructive pulmonary disease (COPD) patients are superior to hospital readmissions.

Detailed Description
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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

Official Title
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Effectiveness of Nurse Lead Telehealth Consultations in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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COPD

Intervention / Treatment
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* Behavioral: Telehealth consultation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth consultation<br>Telehealth nurse consultation plus treatment as usual | Behavioral: Telehealth consultation<br>* 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.<br>* Other names: Telehealth nurse consultation;|
| No Intervention: Conventional<br>Treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of readmissions |  | at 26 weeks after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mortality rate |  | at 26 weeks weeks after discharge | 
| The duration to the first readmission |  | at 26 weeks after discharge | 
| The number of hospital readmissions with exacerbation |  | at 26 weeks after discharge | 
| The number of days readmitted |  | days 26 weeks after discharge | 
| The number of days readmitted with exacerbation |  | days 26 weeks after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, nurse consultation, outpatient clinic