The Virtual Hospital - a Clinical Trial

NCT01155856 | Unknown DMC

• 1 other identifier: H-2-2010-021
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: With the rapid development in technology telemedicine has become a tool with the potential to improve and optimize the treatment of different diseases and to make diagnostics, treatment and counseling possible over shorter or longer distances. Home based telemedicine is a new method that leads to a series of important questions that needs to be answered. This study is designed to answer questions concerning patient safety in telehomecare, the patients´ quality of life, efficiency and a cost benefit analysis of implementing this technology. This study is about patients with chronic obstructive pulmonary disease (COPD) who are admitted to the hospital with an acute exacerbation. Approximately 24 hours after admission half of the patients are randomized to be admitted to their own home supported by telemedical equipment while the other half remain admitted at the hospital (typically between 5-7 days). Primary Aim: To investigate if telemedical surveillance and treatment in the recovery period of an acute exacerbation is just as safe as conventional admission of patients with COPD measured on treatment failure. Secondary Aims: To evaluate if telemedical surveillance and treatment in the recovery period of an acute exacerbation compared to conventional treatment of COPD:

1. 1.Is comparable in reestablishing Forced Expiratory Volume in 1 second (FEV1).
2. 2.Demands the same number of treatment days/time before discharge/cessation of telemedical surveillance.
3. 3.Is comparable in quality of life in the two groups of treated patients.
4. 4.Have comparable adverse event profiles.
5. 5.leads to a lower total cost in health services (health economical analysis)
6. 6.Is possible to do for the patients (drop-outs because of the technical equipment or the patient does not know how to use the equipment.)
7. 7.The virtual patient contact / communication
8. 8.Technology
9. 9.The work process compared to the conventional work process
10. 10.Time spent with the patient
11. 11.Usability
12. 12.Improvement potentials ("the doctors view")

Conditions

Chronic Obstructive Pulmonary Disease; Telemedicine

Keywords

telemedicine; COPD

Outcome Measures

Primary Outcomes (5)

• Death

  To study essential safety parameters for the patients the numbers of deaths will be compared in the two groups using data from the Danish Death Registry.

  30 days, 3 months, 6 months

• readmission

  Readmission can be considered as a treatment failure related to COPD and will thus be assessed in both groups by reviewing the hospital patient administration system.

  30 days, 3 months, 6 months

• need for additional Prednisolone, additional antibiotics , NIV or life support machine (respirator)

  30 days, 3 months, 6 months

• Self-efficacy

  Self-efficacy is measured using "The COPD self-efficacy scale". The scale has been validated in Danish, prior to its use in the current sub studies. The patients will be asked to fill in the questionnaire at baseline, and 3 days after discharge

  3 days

• Cognitive function

  Cognitive function evaluated by a neuropsychological test battery, International Study of Post Operative Cognitive Dysfunction (ISPOCD) including verbal learning, memory capacity and attention.

  3 days and six weeks after discharge

Secondary Outcomes (14)

• FEV1

  30 days, 3 months, 6 months

• Admission days

  30 days

• Healthrelated Quality of life

  baseline, discharge, 4-6 weeks, 3 months, 6 months

• Adverse event

  30 days

• cost in health services

  30 days, 3 months, 6 months

Study Arms (2)

telemedicine

EXPERIMENTAL

Within 24 hours after admission for exacerbation of COPD, patients in the intervention group are sent home for further treatment (telemedicine based) instead of the conventional treatment at the hospital. Patients in the intervention group will receive the same treatment as the control group and have daily contact with the physician/nurse at the hospital through a videoconference system.

Other: Telemedical admission and treatment in the patients´ own homes instead of conventional admission and treatment at the hospital

control

NO INTERVENTION

The control group will receive usual care and treatment at the hospital until discharge(typically between 5-7 days).

Interventions

Telemedical admission and treatment in the patients´ own homes instead of conventional admission and treatment at the hospital OTHER

For this study a telemedical platform has been developed on which it is possible to treat patients in their own homes. The platform consists of a videoconference part that allows the patients to make contact to qualified medical staff and a technology part that can transfer vital indicators of the patients health condition (lung function, oxygen saturation, pulse etc.)175 patients will be included with an expected drop-out of 20 % or 35 patients. The patients will be equally recruited from two hospitals (Frederiksberg and Herlev Hospital). All patients must have an exacerbation in their COPD that requires hospitalization to be included in this study. Each patient participate in the study for 6 months after discharge with follow-up at 1, 3 and 6 months.

telemedicine

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of COPD stage III or IV according to GOLD guidelines
• \>45 years of age
• Compliant patient (is able to see, hear and follow instructions)
• Estimated admission time \> 2 days

You may not qualify if:

• X-score \> 4 at randomization(need of NIV or respirator)
• severe overweight assessed by investigator
• serious comorbidity (malignancy,unstable heart disease, dysregulated diabetes or other disease that makes participation impossible)
• non-compliant patient (cannot follow simple instructions)
• fever (\>38 degrees Celsius) at randomization point, in need of I.V. antibiotics assessed by investigator
• participation in another clinical trial within the last 30 days

Sponsors & Collaborators

• Frederiksberg University Hospital: lead
• TRYG Foundation: collaborator
• The TOYOTA Foundation: collaborator
• Sygekassernes Helsefond: collaborator
• Lykfeldt legat: collaborator
• Frederiksberg Fonden: collaborator
• Danmarks Lungeforening: collaborator

Study Sites (1)

Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Related Publications (1)

• Jakobsen AS, Laursen LC, Ostergaard B, Rydahl-Hansen S, Phanareth KV. Hospital-admitted COPD patients treated at home using telemedicine technology in The Virtual Hospital Trial: methods of a randomized effectiveness trial. Trials. 2013 Sep 3;14:280. doi: 10.1186/1745-6215-14-280.

  PMID: 24139548 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Klaus V Phanareth, ass.professor

  Frederiksberg Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, ph.d, research leader

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: July 2, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

DK (1)