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

University of Southern Denmark (SDU) logo

University of Southern Denmark (SDU)

Status

Completed

Conditions

COPD

Treatments

Behavioral: Telehealth consultation

Study type

Interventional

Funder types

Other

Identifiers

NCT01178879
UNRS-20100030-2

Details and patient eligibility

About

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

Full 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

Enrollment

266 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

266 participants in 2 patient groups

Telehealth consultation
Experimental group
Description:
Telehealth nurse consultation plus treatment as usual
Treatment:
Behavioral: Telehealth consultation
Conventional
No Intervention group
Description:
Treatment as usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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