Selfcare MAnagement InteRvenTion in COPD (SMART COPD)

Copd Clinical Trial

Official title:

Evaluation of a Digital Support and Communication Platform for COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416295
• Other study ID #: SMART-COPD
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Assessment, Self
• Copd
• Hospitalization

Intervention

Device:
• LifePod
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.

Locations

Country	Name	City	State
Sweden	Lund University	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of dyspnea on the basis of modified medical research council dyspnea scale [mMRC]	Dyspnea is measured with mMRC from 0-4 where high figure represent dyspnea in minimal exertion	6 months
Primary	Change in health status and symptom relief based on COPD assessment scale [CAT]	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	6 months
Primary	Change in quality of life	Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life	6 months
Primary	A change in the classification of COPD severity based on GOLD A-D	A change in the classification of COPD severity based on GOLD 1-4 (A-D) where high figure represent worse severity	6 months
Primary	Change in patient reported symptoms	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 months
Primary	Number of participants with COPD related events and deaths during intervention and up to 12 months after inclusion		12 months
Primary	Number of participants with new hospitalization up 12 months after inclusion		12 months
Primary	Number of hospital days during intervention and up 12 months after inclusion		12 months
Primary	Number of health care visits during intervention and up to 12 months after inclusion		12 months