Selfcare MAnagement InteRvenTion in COPD (SMART COPD)

Sponsor

Lund University (Other)

Overall Status

Completed

CT.gov ID

NCT04416295

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Decreased breathlessness on the basis of modified medical research council dyspnea scale [mMRC]
Improved health status and symptom relief based on COPD assessment scale [CAT]
Improved quality of life based on EQ-5D
Reduction in the number of incidents, hospital nights, the number of hospitalizations, outpatient contacts or the number of deaths related to COPD
A change in the classification of COPD severity based on GOLD A-D

Condition or Disease	Intervention/Treatment	Phase
Copd Assessment, Self Hospitalization	Device: LifePod	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Evaluation of a Digital Support and Communication Platform for COPD

Actual Study Start Date :

Aug 1, 2019

Actual Primary Completion Date :

Jan 31, 2021

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard COPD care and a digital COPD support system Device: LifePod The intervention group is testing LifePod on a digital communication platform between patient and healthcare provide	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.
Other: Control group Standard COPD Care	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.

Arm

Intervention/Treatment

Active Comparator: Standard COPD care and a digital COPD support system

Device: LifePod The intervention group is testing LifePod on a digital communication platform between patient and healthcare provide

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.

Other: Control group Standard COPD Care

Device: LifePod

Outcome Measures

Primary Outcome Measures

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
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.
Number of participants with COPD related events and deaths during intervention and up to 12 months after inclusion [12 months]
Number of participants with new hospitalization up 12 months after inclusion [12 months]
Number of hospital days during intervention and up 12 months after inclusion [12 months]
Number of health care visits during intervention and up to 12 months after inclusion [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lund University	Lund	Skåne	Sweden	22100

Sponsors and Collaborators

Lund University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sofia Gerward, Principal Investigator, MD, PhD, Lund University

ClinicalTrials.gov Identifier:

NCT04416295

Other Study ID Numbers:

SMART-COPD

First Posted:

Jun 4, 2020

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 30, 2021