Clinical trial NCT01984840: Telemedicine for Patients Suffering From COPD (Danish Telecare North Trial)
Official title: Effectiveness and Cost-effectiveness of Telemedicine for Chronic Obstructive Pulmonary Disease: The Danish "TeleCare North" Pragmatic Cluster-randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 1225
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Health related quality of life
timeFrame: 12 month follow-up
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
References:
citation: Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.
citation: Witt Udsen F, Lilholt PH, Hejlesen OK, Ehlers LH. Subgroup analysis of telehealthcare for patients with chronic obstructive pulmonary disease: the cluster-randomized Danish Telecare North Trial. Clinicoecon Outcomes Res. 2017 Jul 7;9:391-401. doi: 10.2147/CEOR.S139064. eCollection 2017.
citation: Witt Udsen F, Lilholt PH, Hejlesen O, Ehlers L. Cost-effectiveness of telehealthcare to patients with chronic obstructive pulmonary disease: results from the Danish 'TeleCare North' cluster-randomised trial. BMJ Open. 2017 May 17;7(5):e014616. doi: 10.1136/bmjopen-2016-014616.
citation: Lilholt PH, Witt Udsen F, Ehlers L, Hejlesen OK. Telehealthcare for patients suffering from chronic obstructive pulmonary disease: effects on health-related quality of life: results from the Danish 'TeleCare North' cluster-randomised trial. BMJ Open. 2017 May 9;7(5):e014587. doi: 10.1136/bmjopen-2016-014587.
citation: Lilholt PH, Schaarup C, Hejlesen OK. An Iterative, Mixed Usability Approach Applied to the Telekit System from the Danish TeleCare North Trial. Int J Telemed Appl. 2016;2016:6351734. doi: 10.1155/2016/6351734. Epub 2016 Nov 16.
citation: Udsen FW, Lilholt PH, Hejlesen O, Ehlers LH. Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial. Trials. 2014 May 21;15:178. doi: 10.1186/1745-6215-15-178.