CopdNCT04416295
Selfcare MAnagement InteRvenTion in COPD (SMART COPD)
A study testing LifePod in people with Copd and Assessment, Self, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Copd, Assessment, Self, Hospitalization
- What is being tested?
- LifePod
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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
- Conditions
- Copd, Assessment, Self, Hospitalization
- Being tested
- LifePod
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifePodDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: LifePod |
| Control group Standard COPD Care | Other | Not described Receives: Device: LifePod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 months
Number of participants with COPD related events and deaths during intervention and up to 12 months after inclusion
Measured: 12 months
Number of participants with new hospitalization up 12 months after inclusion
Measured: 12 months
Number of hospital days during intervention and up 12 months after inclusion
Measured: 12 months
Number of health care visits during intervention and up to 12 months after inclusion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Aug 2019
- Primary completion31 Jan 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Gerward, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416295
- Sponsor's protocol ID
- SMART-COPD
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34495549
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Digital Support and Communication Platform for COPD
- ClinicalTrials.gov ID
- NCT04416295
- Acronym / sponsor ID
- SMART-COPD
- Conditions
- Copd, Assessment, Self, Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard COPD care and a digital COPD support system | Active comparator | Device: LifePodDevice: LifePod The intervention group is testing LifePod on a digital communication platform between patient and healthcare provide |
| Control group Standard COPD Care | Other | Device: LifePod |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifePodLifePod 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. | Device | Control group Standard COPD Care, Standard COPD care and a digital COPD support system |
Primary outcome
Severity of dyspnea on the basis of modified medical research council dyspnea scale [mMRC]
Time frame: 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]
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
Number of participants with new hospitalization up 12 months after inclusion
Time frame: 12 months
Number of hospital days during intervention and up 12 months after inclusion
Time frame: 12 months
Number of health care visits during intervention and up to 12 months after inclusion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Derived from this study: PubMed 34495549Poot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifePod in people with Copd and Assessment, Self, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of dyspnea on the basis of modified medical research council dyspnea scale [mMRC] (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.