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Clinical Trials/NCT01984840
NCT01984840
Completed
N/A

Effectiveness and Cost-effectiveness of Telemedicine for Chronic Obstructive Pulmonary Disease: The Danish "TeleCare North" Pragmatic Cluster-randomized Trial.

Aalborg University1 site in 1 country1,225 target enrollmentApril 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pulmonary Disease, Chronic Obstructive
Sponsor
Aalborg University
Enrollment
1225
Locations
1
Primary Endpoint
Incremental cost-effectiveness ratio (ICER)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
January 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Ole K Hejlesen, PhD

Professor

Aalborg University

Eligibility 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

Outcomes

Primary Outcomes

Incremental cost-effectiveness ratio (ICER)

Time Frame: 12 month follow-up

Health related quality of life

Time Frame: 12 month follow-up

SF-36

Study Sites (1)

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