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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01178879
Enrollment
266
Registered
2010-08-10
Start date
2010-05-31
Completion date
2012-02-29
Last updated
2013-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

Telehealth, nurse consultation, outpatient clinic

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

Interventions

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.

Sponsors

Odense University Hospital
CollaboratorOTHER
Sygekassernes Helsefond
CollaboratorOTHER
Danish Nurses Organisation
CollaboratorOTHER
University of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The number of readmissionsat 26 weeks after discharge

Secondary

MeasureTime frame
The mortality rateat 26 weeks weeks after discharge
The duration to the first readmissionat 26 weeks after discharge
The number of hospital readmissions with exacerbationat 26 weeks after discharge
The number of days readmitteddays 26 weeks after discharge
The number of days readmitted with exacerbationdays 26 weeks after discharge

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026