The Virtual Hospital - a Clinical Trial

Chronic Obstructive Pulmonary Disease Clinical Trial

— TVH  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01155856
• Other study ID #: H-2-2010-021
• Status: Active, not recruiting
• Phase: N/A
• First received: June 21, 2010
• Last updated: June 19, 2012
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2012
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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. 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.

Description:

In addition to the main study, two sub studies will be conducted, using the same intervention and subjects as the main study;

1. COPD patients´ self-efficacy after virtual admission compared to hospital admission - implications for clinical practice

2. Cognitive function and daily life after virtual admission compared to conventional hospital admission in patients with chronic obstructive pulmonary disease (COPD)

Ad. 1: COPD patients´ self-efficacy after virtual admission compared to hospital admission - implications for clinical practice

Background:

In order to transfer the patient from the hospital to the telemedicine based homecare treatment regimen, the patient must be able to perform tests and treatments and also contribute to identification of problems and changes in the physical condition. However, so far it has not been investigated whether patients using telehomecare have or acquire the necessary skills to cope with the problems entailed by COPD, in interaction with healthcare professionals and relatives.

Aim:

The primary aim of this sub study is to describe what characterizes COPD patients´ self-efficacy after virtual admission compared to hospital admission.

Method:

Self-efficacy will be measured using "The COPD self-efficacy scale", developed by Wigal et al (Chest 1991). The mean score will be compared between the two study arms, and furthermore the changes within the two groups will be assessed. Data will be collected at baseline, and also three days, six weeks and three months after discharge.

In addition, analyses will be conducted to explore the association between self-efficacy, readmission and the use of bed days during a three month follow-up period.

Ad.2: Cognitive function and daily life after virtual admission compared to conventional hospital admission in patients with chronic obstructive pulmonary disease (COPD)

Background:

COPD affects distant organs and causes several complications, including cognitive dysfunction. The impairment forms a significant clinical problem with consequences for the patients such as dependency on help for basic daily activities, increased symptom experience and poor compliance with medical treatment.

Aim:

The aim of the study is to investigate cognitive function and daily life after virtual admission compared to conventional hospital admission in patients with COPD. The study is a part of a randomized multicenter trial, investigating the feasibility and safety of a telemedicine based treatment regime in COPD patients, compared to conventional hospital treatment (Telemedicine technology makes it possible to communicate with the patient using a video conference system connected to a telemedicine communication platform).

Method:

For this sub study, we consecutively include 150 patients from the multicenter trial. The primary outcome will be cognitive function evaluated by a neuropsychological test battery (ISPOCD), including verbal learning, memory capacity and attention, at discharge, and six weeks after discharge. The secondary outcomes is daily life evaluated by questionnaires including self-reported cognitive function, self-efficacy, activities of daily living, health related quality of life, anxiety and depression, at discharge, six weeks and three months after discharge.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Denmark	Frederiksberg Hospital	Frederiksberg

Sponsors (7)

Lead Sponsor	Collaborator
Frederiksberg University Hospital	Danmarks Lungeforening, Frederiksberg Fonden, Lykfeldt legat, Sygekassernes Helsefond, The TOYOTA Foundation, TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	need for additional Prednisolone, additional antibiotics , NIV or life support machine (respirator)		30 days, 3 months, 6 months	Yes
Primary	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	No
Primary	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	No
Secondary	FEV1	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.	30 days, 3 months, 6 months	No
Secondary	Admission days	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	30 days	No
Secondary	Healthrelated Quality of life	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)	baseline, discharge, 4-6 weeks, 3 months, 6 months	No
Secondary	Adverse event	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	30 days	Yes
Secondary	cost in health services	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)	30 days, 3 months, 6 months	No
Secondary	Telemedicine coping skills	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.	30 days	Yes
Secondary	Patient satisfaction	To evaluate if the equipment is satisfactory for the patient to use (intervention group only). Assessed by questionnaire	30 days	No
Secondary	Physicians/user satisfaction	To evaluate if telemedicine is better than hospital admission, seen from the physicians perspective, when it comes to: The virtual patient contact / communication; Technology; The work process compared to the conventional work process; Amount of time spent with the patient; Usability; Improvement potentials ("the doctors view") assessed by questionnaire intervention group only	30 days	No
Secondary	Number of bed days		30 days	No
Secondary	Self-reported cognitive function	Evaluated by a questionnaire: Subjective Cognitive Functioning (SCF)	3 days, six weeks and three months after discharge	No
Secondary	Self-efficacy	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.	up to 3 months	No
Secondary	Activities of daily living	Evaluated by a questionnaire: Instrumental Activity of Daily Living (IADL)	3 days, six weeks and three months after discharge	No
Secondary	Health related quality of life	Evaluated by a questionnaire: St George Respiratory Questionnaire (SGRQ)	3 days, 6 weeks, 3 months after discharge	No
Secondary	Anxiety and Depression	Evaluated by a questionnaire: Hospital Anxiety and Depression Scale (HADS)	3 days, six weeks and three months after discharge	No