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Clinical Trials/NCT04416295
NCT04416295
Completed
Not Applicable

Evaluation of a Digital Support and Communication Platform for COPD

Lund University1 site in 1 country60 target enrollmentAugust 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Copd
Sponsor
Lund University
Enrollment
60
Locations
1
Primary Endpoint
Number of hospital days during intervention and up 12 months after inclusion
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

To evaluate whether a digital support and communication platform for COPD patients after 6 months provides:

  1. Decreased breathlessness on the basis of modified medical research council dyspnea scale [mMRC]
  2. Improved health status and symptom relief based on COPD assessment scale [CAT]
  3. Improved quality of life based on EQ-5D
  4. Reduction in the number of incidents, hospital nights, the number of hospitalizations, outpatient contacts or the number of deaths related to COPD
  5. A change in the classification of COPD severity based on GOLD A-D
Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
April 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sofia Gerward

Principal Investigator, MD, PhD

Lund University

Eligibility Criteria

Inclusion Criteria

  • The patient is included in the study in connection with visits to COPD.
  • Diagnosed COPD J44 (newly discovered or existing)
  • Have completed the consent form
  • Is judged to be able to handle the intervention himself or with the help of staff or relatives

Exclusion Criteria

  • Patient who declines to participate in the trial.
  • Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner.
  • Life expectancy \<8 months
  • In other ways, treating physicians are deemed to be inappropriate to participate in the study, e.g. due to participation in another study.

Outcomes

Primary Outcomes

Number of hospital days during intervention and up 12 months after inclusion

Time Frame: 12 months

Change in health status and symptom relief based on COPD assessment scale [CAT]

Time Frame: 6 months

Health status and symptom is evaluated with COPD assessment scale (CAT) where the scale is from 0-40 and where high score represent worse health status and symptoms

Change in quality of life

Time Frame: 6 months

Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life

A change in the classification of COPD severity based on GOLD A-D

Time Frame: 6 months

A change in the classification of COPD severity based on GOLD 1-4 (A-D) where high figure represent worse severity

Change in patient reported symptoms

Time Frame: 6 months

Improved patient-reported symptoms as measured by questionnaire EuroQol three-dimensional questionnaire (EQ-5D-3L ) where high score represent worse symptoms. The minimum score is 7 points and the maximum score is 23 points.

Severity of dyspnea on the basis of modified medical research council dyspnea scale [mMRC]

Time Frame: 6 months

Dyspnea is measured with mMRC from 0-4 where high figure represent dyspnea in minimal exertion

Number of participants with new hospitalization up 12 months after inclusion

Time Frame: 12 months

Number of health care visits during intervention and up to 12 months after inclusion

Time Frame: 12 months

Number of participants with COPD related events and deaths during intervention and up to 12 months after inclusion

Time Frame: 12 months

Study Sites (1)

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