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Completed

NCT Number: NCT01178879

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

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth consultation

Behavioral

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 names: Telehealth nurse consultation

Primary outcomes

  1. The number of readmissions

    Time frame: at 26 weeks after discharge

Secondary outcomes

  1. The mortality rate

    Time frame: at 26 weeks weeks after discharge

  2. The duration to the first readmission

    Time frame: at 26 weeks after discharge

  3. The number of hospital readmissions with exacerbation

    Time frame: at 26 weeks after discharge

  4. The number of days readmitted

    Time frame: days 26 weeks after discharge

  5. The number of days readmitted with exacerbation

    Time frame: days 26 weeks after discharge

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Danish Nurses Organisation
  • Odense University Hospital
  • Sygekassernes Helsefond

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2010
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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