Selfcare MAnagement InteRvenTion in COPD (SMART COPD)

NCT04416295 | Completed

• 1 other identifier: SMART-COPD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Copd; Assessment, Self; Hospitalization

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Standard COPD care and a digital COPD support system

ACTIVE COMPARATOR

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

Device: LifePod

Control group Standard COPD Care

OTHER

Device: LifePod

Interventions

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.

Control group Standard COPD Care; Standard COPD care and a digital COPD support system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Lund University

Lund, Skåne County, 22100, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34495549 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: August 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: April 30, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)