The Virtual Hospital - a Clinical Trial (TVH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Frederiksberg University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
TRYG Foundation
The TOYOTA Foundation
Sygekassernes Helsefond
Lykfeldt legat
Frederiksberg Fonden
Danmarks Lungeforening
Information provided by (Responsible Party):
Klaus Phanareth, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01155856
First received: June 21, 2010
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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. Is comparable in reestablishing Forced Expiratory Volume in 1 second (FEV1).
  2. Demands the same number of treatment days/time before discharge/cessation of telemedical surveillance.
  3. Is comparable in quality of life in the two groups of treated patients.
  4. Have comparable adverse event profiles.
  5. leads to a lower total cost in health services (health economical analysis)
  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 Is better seen from the physician's perspective when it comes to:

  1. The virtual patient contact / communication
  2. Technology
  3. The work process compared to the conventional work process
  4. Time spent with the patient
  5. Usability
  6. Improvement potentials ("the doctors view")

    8. The equipment is satisfactory for the patient to use

    Method

    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 participates in the study for 6 months after discharge with follow-up at 1, 3 and 6 months.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Telemedicine
Other: Telemedical admission and treatment in the patients´ own homes instead of conventional admission and treatment at the hospital

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Consecutive, Randomized Controlled Multicenter Trial, Investigating the Feasibility and Safety of a Telemedicine Based Treatment Regimen in Patients With Chronic Obstructive Pulmonary Disease (COPD), Compared to Conventional Hospital Treatment

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • Death [ Time Frame: 30 days, 3 months, 6 months ] [ Designated as safety issue: Yes ]
    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.

  • readmission [ Time Frame: 30 days, 3 months, 6 months ] [ Designated as safety issue: No ]
    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.

  • need for additional Prednisolone, additional antibiotics , NIV or life support machine (respirator) [ Time Frame: 30 days, 3 months, 6 months ] [ Designated as safety issue: Yes ]
  • Self-efficacy [ Time Frame: 3 days ] [ Designated as safety issue: No ]

    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


  • Cognitive function [ Time Frame: 3 days and six weeks after discharge ] [ Designated as safety issue: No ]
    Cognitive function evaluated by a neuropsychological test battery, International Study of Post Operative Cognitive Dysfunction (ISPOCD) including verbal learning, memory capacity and attention.


Secondary Outcome Measures:
  • FEV1 [ Time Frame: 30 days, 3 months, 6 months ] [ Designated as safety issue: No ]
    To evaluate if telemedical surveillance and treatment in the recovery period of an acute exacerbation compared to conventional treatment of COPD: Is comparable in reestablishing FEV1 (stable phase). This is however not possible to compare with patients that have just been diagnosed with COPD.

  • Admission days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To evaluate if telemedical surveillance and treatment in the recovery period of an acute exacerbation compared to conventional treatment of COPD demands the same number of treatment days/time before discharge/cessation of telemedical surveillance

  • Healthrelated Quality of life [ Time Frame: baseline, discharge, 4-6 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]
    To evaluate if telemedical surveillance and treatment in the recovery period of an acute exacerbation compared to conventional treatment of COPD is comparable in quality of life in the two groups of treated patients. Quality of life is measured via questionnaires (EQ-5D, CCQ, SGRQ)

  • Adverse event [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    To evaluate if telemedical surveillance and treatment in the recovery period of an acute exacerbation compared to conventional treatment of COPD have comparable adverse event profiles

  • cost in health services [ Time Frame: 30 days, 3 months, 6 months ] [ Designated as safety issue: No ]
    To evaluate if telemedical surveillance and treatment in the recovery period of an acute exacerbation compared to conventional treatment of COPD leads to a lower total cost in health services (health economical analysis)

  • Telemedicine coping skills [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    To evaluate if telemedical surveillance and treatment in the recovery period of an acute exacerbation compared to conventional treatment of COPD 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.)Intervention group only.

  • Patient satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To evaluate if the equipment is satisfactory for the patient to use (intervention group only). Assessed by questionnaire

  • Physicians/user satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    To evaluate if telemedicine is better than hospital admission, seen from the physicians perspective, when it comes to:

    1. The virtual patient contact / communication
    2. Technology
    3. The work process compared to the conventional work process
    4. Amount of time spent with the patient
    5. Usability
    6. Improvement potentials ("the doctors view") assessed by questionnaire intervention group only

  • Number of bed days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Self-reported cognitive function [ Time Frame: 3 days, six weeks and three months after discharge ] [ Designated as safety issue: No ]
    Evaluated by a questionnaire: Subjective Cognitive Functioning (SCF)

  • Self-efficacy [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    Evaluated by the COPD Self Efficacy Scale (CSES). Will be evaluated at baseline, three days after discharge, and also six weeks and three months after discharge.

  • Activities of daily living [ Time Frame: 3 days, six weeks and three months after discharge ] [ Designated as safety issue: No ]
    Evaluated by a questionnaire: Instrumental Activity of Daily Living (IADL)

  • Health related quality of life [ Time Frame: 3 days, 6 weeks, 3 months after discharge ] [ Designated as safety issue: No ]
    Evaluated by a questionnaire: St George Respiratory Questionnaire (SGRQ)

  • Anxiety and Depression [ Time Frame: 3 days, six weeks and three months after discharge ] [ Designated as safety issue: No ]
    Evaluated by a questionnaire: Hospital Anxiety and Depression Scale (HADS)


Estimated Enrollment: 175
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: telemedicine
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
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.
No Intervention: control
The control group will receive usual care and treatment at the hospital until discharge(typically between 5-7 days).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155856

Locations
Denmark
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
TRYG Foundation
The TOYOTA Foundation
Sygekassernes Helsefond
Lykfeldt legat
Frederiksberg Fonden
Danmarks Lungeforening
Investigators
Study Director: Klaus V Phanareth, ass.professor Frederiksberg Hospital
  More Information

No publications provided

Responsible Party: Klaus Phanareth, MD, ph.d, research leader, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01155856     History of Changes
Other Study ID Numbers: H-2-2010-021
Study First Received: June 21, 2010
Last Updated: June 19, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Frederiksberg University Hospital:
telemedicine
COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014