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NCT04485832 Clinical Trial

Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04485832
Other study ID # BASEC Nr. 2015-00065
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 5, 2016
Est. completion date December 1, 2019

Study information
Verified date July 2020
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this randomised controlled trial is to test, whether telehealthcare can improve HRQOL and reduce emergency admissions and hospitalisations due to AECOPD. Different outcome parameters as described in the endpoints section will be analysed.

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date December 1, 2019
Est. primary completion date September 25, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- COPD GOLD B-D and age = 40 years

Exclusion Criteria:

- Inability to provide informed consent or to follow trial procedures

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Telehealth care
Patients in the intervention group daily answer 6 questions, which are focused on the recognition of AECOPD, using the electronic healthcare platform Evita by Swisscom, which has been and continuously is developed by the study team and Swisscom. The study team daily analyses all patients online and reacts according to a pre-specified action plan.
Diagnostic Test:
• Weekly CAT measurement

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cantonal Hospital of St. Gallen

Outcome
Type Measure Description Time frame Safety issue
Primary Change of COPD assessment test (CAT) at 6 months (slope of the linear regression trend) 1 year after inclusion
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