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

This study has been completed.
Sponsor:
Collaborators:
Odense University Hospital
Sygekassernes Helsefond
Danish Nurse Organisation
Information provided by (Responsible Party):
Birte Oestergaard, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01178879
First received: August 9, 2010
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
COPD
Behavioral: Telehealth consultation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Nurse Lead Telehealth Consultations in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • The number of readmissions [ Time Frame: at 26 weeks after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mortality rate [ Time Frame: at 26 weeks weeks after discharge ] [ Designated as safety issue: No ]
  • The duration to the first readmission [ Time Frame: at 26 weeks after discharge ] [ Designated as safety issue: No ]
  • The number of hospital readmissions with exacerbation [ Time Frame: at 26 weeks after discharge ] [ Designated as safety issue: No ]
  • The number of days readmitted [ Time Frame: days 26 weeks after discharge ] [ Designated as safety issue: No ]
  • The number of days readmitted with exacerbation [ Time Frame: days 26 weeks after discharge ] [ Designated as safety issue: No ]

Enrollment: 266
Study Start Date: May 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telehealth consultation
Telehealth nurse consultation plus treatment as usual
Behavioral: 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 Name: Telehealth nurse consultation
No Intervention: Conventional
Treatment as usual

Detailed Description:

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:

  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
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178879

Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Sygekassernes Helsefond
Danish Nurse Organisation
Investigators
Principal Investigator: Anne Dichmann Sorknaes, PhD student University of Southern Denmark
  More Information

Publications:
Responsible Party: Birte Oestergaard, Associate professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01178879     History of Changes
Other Study ID Numbers: UNRS-20100030-2
Study First Received: August 9, 2010
Last Updated: June 27, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Telehealth
nurse consultation
outpatient clinic

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014