Selfcare MAnagement InteRvenTion in COPD (SMART COPD)

Not Applicable

Completed

• Conditions: Copd; Hospitalization; Assessment, Self
• Interventions: Device: LifePod

• Registration Number: NCT04416295
• Lead Sponsor: Lund University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-04
• Primary Completion: 2021-01-31
• Study Completion: 2021-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard COPD care and a digital COPD support system	LifePod	Device: LifePod The intervention group is testing LifePod on a digital communication platform between patient and healthcare provide
Control group Standard COPD Care	LifePod	-

Primary Outcome Measures

Name	Time	Method
Number of hospital days during intervention and up 12 months after inclusion	12 months
Change in health status and symptom relief based on COPD assessment scale [CAT]	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	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	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	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]	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	12 months
Number of health care visits during intervention and up to 12 months after inclusion	12 months
Number of participants with COPD related events and deaths during intervention and up to 12 months after inclusion	12 months

Trial Locations

Locations (1)

Lund University; 🇸🇪 Lund, Skåne, Sweden