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

Primary Purpose

COPD

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telehealth consultation
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Telehealth, nurse consultation, outpatient clinic

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telehealth consultation

Conventional

Arm Description

Telehealth nurse consultation plus treatment as usual

Treatment as usual

Outcomes

Primary Outcome Measures

The number of readmissions

Secondary Outcome Measures

The mortality rate
The duration to the first readmission
The number of hospital readmissions with exacerbation
The number of days readmitted
The number of days readmitted with exacerbation

Full Information

First Posted
August 9, 2010
Last Updated
June 27, 2013
Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Sygekassernes Helsefond, Danish Nurses Organisation
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1. Study Identification

Unique Protocol Identification Number
NCT01178879
Brief Title
Randomised Trial of Telehealth Consultations for Nursing Care of Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Effectiveness of Nurse Lead Telehealth Consultations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Sygekassernes Helsefond, Danish Nurses Organisation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: The total number of readmissions can be reduced with 14% The time to the first readmission will be prolonged The number of readmissions with exacerbation can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment The total number of readmission days can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment 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 The mortality rate will remain unchanged after the telehealth consultations as a supplement to the conventional treatment compared with conventional treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Telehealth, nurse consultation, outpatient clinic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telehealth consultation
Arm Type
Experimental
Arm Description
Telehealth nurse consultation plus treatment as usual
Arm Title
Conventional
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Telehealth consultation
Other Intervention Name(s)
Telehealth nurse consultation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of readmissions
Time Frame
at 26 weeks after discharge
Secondary Outcome Measure Information:
Title
The mortality rate
Time Frame
at 26 weeks weeks after discharge
Title
The duration to the first readmission
Time Frame
at 26 weeks after discharge
Title
The number of hospital readmissions with exacerbation
Time Frame
at 26 weeks after discharge
Title
The number of days readmitted
Time Frame
days 26 weeks after discharge
Title
The number of days readmitted with exacerbation
Time Frame
days 26 weeks after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Dichmann Sorknaes, PhD student
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
9167458
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. doi: 10.1016/S0140-6736(96)07492-2.
Results Reference
background
Citation
(2) Sundhedsstyrelsen. Genindlæggelser af ældre i Danmark 2008 - Nye tal fra Sundhedsstyrelsen. 1060. Ref Type: Internet Communication.
Results Reference
background
PubMed Identifier
14531348
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.
Results Reference
background
PubMed Identifier
16611656
Citation
Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin 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. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.
Results Reference
background
PubMed Identifier
16620167
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. doi: 10.1089/tmj.2006.12.128.
Results Reference
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Randomised Trial of Telehealth Consultations for Nursing Care of Chronic Obstructive Pulmonary Disease (COPD) Patients

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