Selfcare MAnagement InteRvenTion in COPD (SMART COPD)

Evaluation of a Digital Support and Communication Platform for 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

Study Overview

• Status: Completed
• Conditions: Copd; Hospitalization; Assessment, Self
• Intervention / Treatment: Device: LifePod

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 22100
      • Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Lund University

Publications and helpful links

General Publications

• Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SMART-COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No