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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Behavioral: Telehealth consultation

• Registration Number: NCT01178879
• Lead Sponsor: University of Southern Denmark

Brief Summary

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

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

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-10
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-27
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telehealth consultation	Telehealth consultation	Telehealth nurse consultation plus treatment as usual

Primary Outcome Measures

Name	Time	Method
The number of readmissions	at 26 weeks after discharge

Secondary Outcome Measures

Name	Time	Method
The number of hospital readmissions with exacerbation	at 26 weeks after discharge
The duration to the first readmission	at 26 weeks after discharge
The number of days readmitted	days 26 weeks after discharge
The mortality rate	at 26 weeks weeks after discharge
The number of days readmitted with exacerbation	days 26 weeks after discharge

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark