Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial
Sponsor
Cantonal Hospital of St. Gallen (Other)
Overall Status
Completed
CT.gov ID
NCT04485832
Collaborator
(none)
168
2
43.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
168 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial
Actual Study Start Date
:
Apr 5, 2016
Actual Primary Completion Date
:
Sep 25, 2019
Actual Study Completion Date
:
Dec 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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
|
| Active Comparator: Control
|
Diagnostic Test: Weekly CAT measurement
|
Outcome Measures
Primary Outcome Measures
- Change of COPD assessment test (CAT) at 6 months (slope of the linear regression trend) [1 year after inclusion]
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- COPD GOLD B-D and age ≥ 40 years
Exclusion Criteria:
- Inability to provide informed consent or to follow trial procedures
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Cantonal Hospital of St. Gallen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Frank Rassouli,
PD Dr. med.,
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT04485832
Other Study ID Numbers:
- BASEC Nr. 2015-00065
First Posted:
Jul 24, 2020
Last Update Posted:
Jul 24, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: