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Nurse Tele-Consultations With Discharged COPD Patients Reduce the Numbers of Readmissions

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telemonitor
Sponsored by
Svendborg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Disease, Chronic Obstructive focused on measuring pervasive healthcare, telecare, telemedicine, COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Exacerbation in COPD with dyspnea, cough
  • Need for medical treatment
  • Age above 40 years
  • Above 10 pack years
  • The ability to use a phone

Exclusion Criteria:

  • Communication problems
  • Respiratory acidosis
  • No other severe medical disease as cancer, sepsis, shock, pneumonia

Sites / Locations

  • Medical Department, OUH Svendborg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1 Telemonitor

Control group

Arm Description

Within 24 hours after the patient was discharged the telemedicine equipment was installed at the patient's home. The patients were included for four weeks followed by a visit to the outpatient clinic with a doctor. The patient was planned to have the equipment for approximately one week and had at least one follow-up phone call within the four weeks period. Telemonitoring video conferences could be made from 8 AM to 3 PM every day. The patient could call the telemedicine department in the same period of time (hot-line).

No tele-monitor at home. The COPD patients discharged after an acute exacerbation living outside Svendborg or Faaborg-Midtfyn municipalities in the recruiting area were included in the control group and assigned to conventional care.

Outcomes

Primary Outcome Measures

readmission to hospital

Secondary Outcome Measures

the duration of hospital readmission

Full Information

First Posted
June 3, 2009
Last Updated
June 10, 2009
Sponsor
Svendborg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00918905
Brief Title
Nurse Tele-Consultations With Discharged COPD Patients Reduce the Numbers of Readmissions
Official Title
KOL-Fyn - an Explorative Study Wtih Telemedicine in COPD Patients at Home
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Svendborg Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with COPD are often admitted to the hospital with an exacerbation. It is the most common cause for admissions to medical wards. The patients are often readmitted. This is har great impact on health economy and is a significant factor to medical beds. The aim of this study was to investigate the effect of telemedicine consultations between respiratory nurses at the hospital and COPD patients in their homes after a discharge from the hospital, which was caused by an exacerbation.
Detailed Description
Participants All patients admitted acutely to the medical ward for respiratory diseases at Odense University Hospital, Svendborg from the 4th of June 2007 until the 15th of Marts 2008 and from the 8th of August 2008 until the 6th of January 2009 were candidates if they had ECOPD defined as COPD with more dyspnoea, more cough and/or more sputum and a need for increased medication. The inclusion and exclusion criteria as mentioned in eligibility criteria. The ECOPD patients included lived at Funen County, Denmark in the recruiting area of Odense University Hospital, Svendborg. In order to further characterize the patients at baseline, we retrieved data from the Funen County Patient Administrative System (FPAS) and the Odense University Pharmacoepidemiological Database (OPED). In brief, FPAS holds discharge diagnoses on all in-patient contacts in Funen County since 1973 and out-patient secondary care contacts since 1989. Diagnoses are coded according to the ICD8 until 1993 and ICD10 from 1994. OPED is a research database that holds information on reimbursed prescription from Funen County since 1990. All respiratory drugs are covered by the plan. Interventions The telemedicine equipment consisted of a computer with web camera, microphone and measurement equipment with one bottom to contact to the respiratory nurse at the hospital and one alarm bottom. The nurse and the patient were able to see each other and to talk together and the nurse was able to measure saturation and perform a spirometry. The results were transferred to the hospital by a secure internet line. The equipment was especially designed to the ECOPD patients in cooperation between the OUH, Svendborg Hospital and a private company, Global IT Systems. Its popular name is "The Patient Suitcase". Within 24 hours after the patient was discharged the telemedicine equipment was installed at the patient's home by a technician, who also collected and cleaned the equipment after use. The patients were included for four weeks followed by a visit to the outpatient clinic with a doctor. The patient was planned to have the equipment for approximately one week and had at least one follow-up phone call within the four weeks period. TVC could be made from 8 AM to 3 PM every day. The patient could call the telemedicine department in the same period of time. During the TVC the nurse made clinical observations (i.e. dyspnoea, general condition, physical activity, anxiety), measured saturation and lung function and informed the patients how to prevent exacerbations and how to use the medication. Anxiety was estimated. The telemedicine consultation was agreed on with the patient and the telemedicine nurse from day to day. If the TVC patient were readmitted, the patient stopped with telemedicine consultations and the telemedicine equipment was collected. All ECOPD patients who fulfilled the inclusion criteria and none of the exclusion criteria were consecutively divided into two groups due to home municipality. ECOPD patients who lived in Svendborg or Faaborg-Midtfyn municipality were included in the TVC-group and ECOPD patients from other municipalities were included in the control group. Implementation Obviously, the study was not blinded. Every day between 8-9 AM all patients admitted to the medical ward for respiratory diseases were screened by a nurse. Patients who fulfilled the inclusion criteria's and none of the exclusion criteria's gave informed consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
pervasive healthcare, telecare, telemedicine, COPD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Telemonitor
Arm Type
Experimental
Arm Description
Within 24 hours after the patient was discharged the telemedicine equipment was installed at the patient's home. The patients were included for four weeks followed by a visit to the outpatient clinic with a doctor. The patient was planned to have the equipment for approximately one week and had at least one follow-up phone call within the four weeks period. Telemonitoring video conferences could be made from 8 AM to 3 PM every day. The patient could call the telemedicine department in the same period of time (hot-line).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No tele-monitor at home. The COPD patients discharged after an acute exacerbation living outside Svendborg or Faaborg-Midtfyn municipalities in the recruiting area were included in the control group and assigned to conventional care.
Intervention Type
Device
Intervention Name(s)
Telemonitor
Other Intervention Name(s)
telemonitoring, integrated care, telemedicine
Intervention Description
Within 24 hours after the patient was discharged due to exacerbation in COPD the telemedicine equipment was installed at the patient's home. The patients were included for four weeks followed by a visit to the outpatient clinic with. The patient had the equipment for approximately one week and had at least one follow-up phone call. Televideo consultations could be made from 8 AM to 3 PM every day. The patient could call the telemedicine department in the same period. During the televideo consultations the nurse made clinical observations (i.e. dyspnoea, anxiety), measured saturation and lung function and informed the patients how to prevent exacerbations. The telemedicine consultation was agreed on with the patient and the telemedicine nurse from day to day.
Primary Outcome Measure Information:
Title
readmission to hospital
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
the duration of hospital readmission
Time Frame
days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Exacerbation in COPD with dyspnea, cough Need for medical treatment Age above 40 years Above 10 pack years The ability to use a phone Exclusion Criteria: Communication problems Respiratory acidosis No other severe medical disease as cancer, sepsis, shock, pneumonia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Madsen, Ph.D.
Organizational Affiliation
Medical Department, OUH Svendborg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Department, OUH Svendborg Hospital
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark

12. IPD Sharing Statement

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Nurse Tele-Consultations With Discharged COPD Patients Reduce the Numbers of Readmissions

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