Selfcare MAnagement InteRvenTion in COPD (SMART COPD)

NCT ID: NCT04416295

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-04-30

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

Conditions

Copd; Assessment, Self; Hospitalization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

LifePod

Intervention Type: 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

Group Type: OTHER

LifePod

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Sofia Gerward

Principal Investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lund University

Lund, Skåne County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 34495549 (View on PubMed)

Other Identifiers

SMART-COPD

Identifier Type: -

Identifier Source: org_study_id