NCT00918905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

Enrollment Period

1.7 years

First QC Date

June 3, 2009

Last Update Submit

June 10, 2009

Conditions

Keywords

pervasive healthcaretelecaretelemedicineCOPD

Outcome Measures

Primary Outcomes (1)

  • readmission to hospital

    4 weeks

Secondary Outcomes (1)

  • the duration of hospital readmission

    days

Study Arms (2)

1 Telemonitor

EXPERIMENTAL

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).

Device: Telemonitor

Control group

NO INTERVENTION

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.

Interventions

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.

Also known as: telemonitoring, integrated care, telemedicine
1 Telemonitor

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Department, OUH Svendborg Hospital

Svendborg, 5700, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hanne Madsen, Ph.D.

    Medical Department, OUH Svendborg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 11, 2009

Study Start

June 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations