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Telemedicine for Patients Suffering From COPD (Danish Telecare North Trial) (TCN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01984840
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Ole K Hejlesen, PhD, Aalborg University

Brief Summary:

There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from COPD that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with COPD across patients and municipality districts.

It is hypothesized that telehealth care will increase patients quality adjusted life years at both the cluster and individual level compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Device: Telemedicine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Cost-effectiveness of Telemedicine for Chronic Obstructive Pulmonary Disease: The Danish "TeleCare North" Pragmatic Cluster-randomized Trial.
Study Start Date : April 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Telemedicine
A tablet (a Samsung GALAXY TAB 2 (10.1)) that holds information on handling COPD in general and software that automatically instructs the patient in handling COPD during exacerbations. The device can also collect and transmit relevant disease-specific data, which are indicative of their current state of health, via an attached Fingertip Pulse Oximeter (Nonin, Onyx II % SpO2), a Digital Blood Pressure Monitor (Model UA-767, plus BT-C) and a scale. The device can measure four vital signs, which are transferred wirelessly: blood pressure, pulse, blood oxygen saturation and weight. The tablet can be activated and give a sound, when it is time for taking measurements again.
Device: Telemedicine
No Intervention: Usual care
In Denmark, usual practice for treating, monitoring and caring for patients with COPD are the responsibility of the patient's general practitioner (treatment and monitoring) and the municipalities (practical help and nursing care). COPD patients can make appointments with their general practitioner or practice nurse free of charge in order to get help in managing COPD. Community based care and practical help varies. As a rule community care comes at regular intervals based on a clinically based estimate of the patients' needs, but the personnel are not necessarily certified nurses and often not fully educated in COPD and definitely not on call



Primary Outcome Measures :
  1. Health related quality of life [ Time Frame: 12 month follow-up ]
    SF-36

  2. Incremental cost-effectiveness ratio (ICER) [ Time Frame: 12 month follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed COPD by spirometry
  • in treatment corresponding to GOLD-guidelines
  • motivated for treatment of COPD
  • COPD is the primary disease
  • fixed residence and be affiliated to a general practitioner in North Denmark Region
  • At least one of the following criteria should also be met: MRCm (modified) ≥ 2 or MRC ≥3, CAT ≥ 10, have had at least 2 exacerbations within the last 12 months

Exclusion Criteria:

  • no phone line or GSM coverage
  • unable to understand Danish sufficiently to complete study questionnaires
  • have a cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984840


Locations
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Denmark
Aalborg University
Aalborg, Denmark, 9220
Sponsors and Collaborators
Aalborg University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ole K Hejlesen, PhD, Professor, Aalborg University
ClinicalTrials.gov Identifier: NCT01984840    
Other Study ID Numbers: RN-TN-001
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive