COPDNCT07031440
Digital Delivery of Living Well With COPD for Patient Education and Self-management - a Mixed-method Study
A study testing digital LWWCOPD in people with COPD, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
COPD (Chronic Obstructive Pulmonary Disease) is a common lung disease. People suffering from COPD typically experience shortness of breath, coughing, and mucus production. The condition is usually treated with medication, but it is equally important that patients are well-informed about COPD and receive guidance on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- digital LWWCOPD
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of COPD (any stage and severity)
- Able to speak/read/understand German or French
- Access to a cell phone, tablet or personal desktop computer with active internet access
- Willing and able to understand and provide written informed consent
- Current or recent enrolment in a pulmonary rehabilitation program is permitted
Who cannot join
- Inability to follow the procedures/instructions of the study or to participate in the intervention (e.g. due to language or cognitive barriers, psychological disorders, physical reasons)
- Patients already having completed the conventional LWWCOPD
About this study
COPD (Chronic Obstructive Pulmonary Disease) is a common lung disease. People suffering from COPD typically experience shortness of breath, coughing, and mucus production. The condition is usually treated with medication, but it is equally important that patients are well-informed about COPD and receive guidance on how to live with it.
The currently available program, "Living well with COPD (LWWCOPD)," is a patient education and self-management program offered on-site in healthcare institutions (such as the Lung League) over six sessions across six weeks. Studies have shown that participating in this program can improve quality of life and overall health, and COPD patients who have completed it tend to require hospitalization less frequently.
However, not all patients who could benefit from the program are able to attend in person-either due to the fixed schedule or because traveling to the training site is too difficult. Therefore, this study aims to determine whether the digital version of the "Living well with COPD" program is equally effective and perhaps more convenient for some patients. The digital version closely mirrors the existing program and consists of various modules that provide information about COPD and practical strategies for managing the disease in daily life. Only once its effectiveness is scientifically proven can the digital version be implemented in Switzerland for COPD patients.
- Conditions
- COPD
- Being tested
- digital LWWCOPD
- 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.
digital LWWCOPDBehavioural
LWWCOPD (Living well with COPD) contains six modules conventionally delivered by trained LWWCOPD Coaches. For the digital delivery the six modules are as closely adapted to the conventional LWWCOPD program as possible to make the two approaches comparable. Participants can access the digital LWWCOPD application by a weblink using a smartphone, tablet or desktop computer. Since the program duration of the conventional LWWCOPD is 6 weeks (one module per week), patients will be instructed to complete the digital LWWCOPD also within 6 weeks at their own pace, although completion within 12 weeks (3 months) is still possible. Modules can be repeated as chosen by the user. In contrast to the conventional delivery, the online delivery of LWWCOPD does not preview face-to-face contact between participants and healthcare providers, however if needed additional phone calls or meetings are still possible.
| Study group | Role | What they receive |
|---|---|---|
| digital LWWCOPD | Other | Not described Receives: Behavioral: digital LWWCOPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HRQoL (Health-Related Quality of Life)
Change in HRQoL, assessed by the Chronic Respiratory Disease Questionnaire (CRQ) from baseline (before start with digital LWWCOPD program) to three months follow-up (after completion of digital LWWCOPD program)
Measured: From enrollment to the end of intervention at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen, University Hospital, Geneva
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031440
- Sponsor's protocol ID
- STD0007385
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Delivery of Living Well With COPD for Patient Education and Self-management - a Mixed-method Study
- ClinicalTrials.gov ID
- NCT07031440
- Acronym / sponsor ID
- STD0007385
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen, University Hospital, Geneva
- Study start
- Aug 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 22 Jun 2025 (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.
COPD (Chronic Obstructive Pulmonary Disease) is a common lung disease. People suffering from COPD typically experience shortness of breath, coughing, and mucus production. The condition is usually treated with medication, but it is equally important that patients are well-informed about COPD and receive guidance on how to live with it.
The currently available program, "Living well with COPD (LWWCOPD)," is a patient education and self-management program offered on-site in healthcare institutions (such as the Lung League) over six sessions across six weeks. Studies have shown that participating in this program can improve quality of life and overall health, and COPD patients who have completed it tend to require hospitalization less frequently.
However, not all patients who could benefit from the program are able to attend in person-either due to the fixed schedule or because traveling to the training site is too difficult. Therefore, this study aims to determine whether the digital version of the "Living well with COPD" program is equally effective and perhaps more convenient for some patients. The digital version closely mirrors the existing program and consists of various modules that provide information about COPD and practical strategies for managing the disease in daily life. Only once its effectiveness is scientifically proven can the digital version be implemented in Switzerland for COPD patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| digital LWWCOPD | Other | Behavioral: digital LWWCOPD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Diagnosis of COPD (any stage and severity)
- Able to speak/read/understand German or French
- Access to a cell phone, tablet or personal desktop computer with active internet access
- Willing and able to understand and provide written informed consent
Key exclusion criteria (2 listed)
- Inability to follow the procedures/instructions of the study or to participate in the intervention (e.g. due to language or cognitive barriers, psychological disorders, physical reasons)
- Patients already having completed the conventional LWWCOPD
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 |
|---|---|---|
| digital LWWCOPDLWWCOPD (Living well with COPD) contains six modules conventionally delivered by trained LWWCOPD Coaches. For the digital delivery the six modules are as closely adapted to the conventional LWWCOPD program as possible to make the two approaches comparable. Participants can access the digital LWWCOPD application by a weblink using a smartphone, tablet or desktop computer. Since the program duration of the conventional LWWCOPD is 6 weeks (one module per week), patients will be instructed to complete the digital LWWCOPD also within 6 weeks at their own pace, although completion within 12 weeks (3 months) is still possible. Modules can be repeated as chosen by the user. In contrast to the conventional delivery, the online delivery of LWWCOPD does not preview face-to-face contact between participants and healthcare providers, however if needed additional phone calls or meetings are still possible. | Behavioural | digital LWWCOPD |
Primary outcome
Change in HRQoL (Health-Related Quality of Life)
Time frame: From enrollment to the end of intervention at 3 months
Change in HRQoL, assessed by the Chronic Respiratory Disease Questionnaire (CRQ) from baseline (before start with digital LWWCOPD program) to three months follow-up (after completion of digital LWWCOPD program)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing digital LWWCOPD in people with COPD, run by Insel Gruppe AG, University Hospital Bern.
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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in HRQoL (Health-Related Quality of Life) (time frame: From enrollment to the end of intervention at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2025.