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

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

Sponsors

Lead Sponsor: Cantonal Hospital of St. Gallen

Source Cantonal Hospital of St. Gallen
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.

Overall Status Completed
Start Date April 5, 2016
Completion Date December 1, 2019
Primary Completion Date September 25, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change of COPD assessment test (CAT) at 6 months (slope of the linear regression trend) 1 year after inclusion
Enrollment 168
Condition
Intervention

Intervention Type: Device

Intervention Name: Telehealth care

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.

Arm Group Label: Intervention

Intervention Type: Diagnostic Test

Intervention Name: Weekly CAT measurement

Eligibility

Criteria:

Inclusion Criteria:

- COPD GOLD B-D and age ≥ 40 years

Exclusion Criteria:

- Inability to provide informed consent or to follow trial procedures

Gender: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: No

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cantonal Hospital of St. Gallen

Investigator Full Name: Frank Rassouli

Investigator Title: PD Dr. med.

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention

Type: Active Comparator

Label: Control

Type: Active Comparator

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov