NCT04485832

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

July 22, 2020

Last Update Submit

July 22, 2020

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Change of COPD assessment test (CAT) at 6 months (slope of the linear regression trend)

    1 year after inclusion

Study Arms (2)

Intervention

ACTIVE COMPARATOR
Device: Telehealth careDiagnostic Test: Weekly CAT measurement

Control

ACTIVE COMPARATOR
Diagnostic Test: Weekly CAT measurement

Interventions

Telehealth careDEVICE

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
Weekly CAT measurementDIAGNOSTIC_TEST
ControlIntervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD GOLD B-D and age ≥ 40 years

You may not qualify if:

  • Inability to provide informed consent or to follow trial procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 24, 2020

Study Start

April 5, 2016

Primary Completion

September 25, 2019

Study Completion

December 1, 2019

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share