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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178879
• Other study ID #: UNRS-20100030-2
• Status: Completed
• Phase: N/A
• First received: August 9, 2010
• Last updated: June 27, 2013
• Start date: May 2010
• Est. completion date: February 2012

Study information

• Verified date: June 2013
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Nurses Organisation, Odense University Hospital, Sygekassernes Helsefond

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

(2) Sundhedsstyrelsen. Genindlæggelser af ældre i Danmark 2008 - Nye tal fra Sundhedsstyrelsen. 1060. Ref Type: Internet Communication.

Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernández C, Alonso A, del Pozo F, de Toledo P, Antó JM, Rodríguez-Roisín R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. Epub 2006 Apr 12. — View Citation

Eriksen N, Hansen EF, Munch EP, Rasmussen FV, Vestbo J. [Chronic obstructive pulmonary disease. Admission, course and prognosis]. Ugeskr Laeger. 2003 Sep 8;165(37):3499-502. Danish. — View Citation

Finkelstein SM, Speedie SM, Potthoff S. Home telehealth improves clinical outcomes at lower cost for home healthcare. Telemed J E Health. 2006 Apr;12(2):128-36. — View Citation

Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet. 1997 May 24;349(9064):1498-504. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of readmissions		at 26 weeks after discharge	No
Secondary	The mortality rate		at 26 weeks weeks after discharge	No
Secondary	The duration to the first readmission		at 26 weeks after discharge	No
Secondary	The number of hospital readmissions with exacerbation		at 26 weeks after discharge	No
Secondary	The number of days readmitted		days 26 weeks after discharge	No
Secondary	The number of days readmitted with exacerbation		days 26 weeks after discharge	No