Back to resultsTelehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telehealth care
Weekly CAT measurement
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- COPD GOLD B-D and age ≥ 40 years
Exclusion Criteria:
- Inability to provide informed consent or to follow trial procedures
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Change of COPD assessment test (CAT) at 6 months (slope of the linear regression trend)
Secondary Outcome Measures
Full Information
NCT ID
NCT04485832
First Posted
July 22, 2020
Last Updated
July 22, 2020
Sponsor
Cantonal Hospital of St. Gallen
1. Study Identification
Unique Protocol Identification Number
NCT04485832
Brief Title
Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial
Official Title
Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2016 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Telehealth care
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Weekly CAT measurement
Primary Outcome Measure Information:
Title
Change of COPD assessment test (CAT) at 6 months (slope of the linear regression trend)
Time Frame
1 year after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD GOLD B-D and age ≥ 40 years
Exclusion Criteria:
Inability to provide informed consent or to follow trial procedures
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial
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