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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— TCN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984840
• Other study ID #: RN-TN-001
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: June 16, 2016
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2016
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1225
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Telemedicine

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life	SF-36	12 month follow-up	No
Primary	Incremental cost-effectiveness ratio (ICER)		12 month follow-up	No

External Links

•   Danish site for the trial (no website in english available at this time)