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OpenTrials
Completed

NCT Number: NCT04416295

Selfcare MAnagement InteRvenTion in COPD (SMART COPD)

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

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Key information

Conditions

COPD Assessment, Self Chronic Disease Disease Attributes Hospitalization Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University

Lund, Skåne County, 22100, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LifePod

Device

LifePod consists of a Web-based E-Health platform with two interfaces, one medical for healthcare professionals and one patient interface. LifePod is accessed via a smartphone, tablets and computers via a web application where patients enter symptom parameters and vital parameters such as breathing and mucus status, weight, activity, medication or other disease-specific values. Several different validated questionnaires are sent regularly to the patient to obtain information about the patient's mood and activity. The platform contains a chat function between healthcare professionals and patients. A unique health profile is created in which the patient self-reports their health. The patient receives direct feedback in their web application if they are within the interval given for the individual. The medical interfaces are designed so that patients are automatically placed in a priority order where the person outside the given range is given top priority.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

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

    Time frame: 12 months

  7. Number of participants with new hospitalization up 12 months after inclusion

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

Evaluation of a Digital Support and Communication Platform for COPD

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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