- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04485832
Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial
July 22, 2020 updated by: Frank Rassouli, Cantonal Hospital of St. Gallen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- COPD GOLD B-D and age ≥ 40 years
Exclusion Criteria:
- Inability to provide informed consent or to follow trial procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
|
|
Active Comparator: Intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of COPD assessment test (CAT) at 6 months (slope of the linear regression trend)
Time Frame: 1 year after inclusion
|
1 year after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 5, 2016
Primary Completion (Actual)
September 25, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
July 22, 2020
First Submitted That Met QC Criteria
July 22, 2020
First Posted (Actual)
July 24, 2020
Study Record Updates
Last Update Posted (Actual)
July 24, 2020
Last Update Submitted That Met QC Criteria
July 22, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASEC Nr. 2015-00065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Telehealth care
-
Novartis PharmaceuticalsInnovative Medicines InitiativeWithdrawn
-
Hospital de Clinicas de Porto AlegreEnrolling by invitation
-
Boston Children's HospitalCompleted
-
Kyle KosikRecruitingQuality of Life | Acute Pain | Telerehabilitation | Implementation Science | Ankle Sprains | Analgesics, Non-narcotic | Anti-Inflammatory Agents, Non-Steroidal | Analgesic, OpioidUnited States
-
Oregon Health and Science UniversityUniversity of PennsylvaniaCompletedDementia | Advanced Care PlanningUnited States
-
National Taiwan University HospitalUnknownChronic Obstructive Pulmonary DiseaseTaiwan
-
Peking University Third HospitalRecruitingHyperlipidemia | Cardiometabolic DiseaseChina
-
HealthPartners InstitutePatient-Centered Outcomes Research InstituteCompleted
-
University of California, DavisRecruiting
-
University of VirginiaCongressionally Directed Medical Research ProgramsActive, not recruitingAlzheimer Disease | Traumatic Brain Injury | Dementia, Mixed | Dementia Mild | Dementia ModerateUnited States