Chronic Obstructive Pulmonary Disease (COPD)NCT06850961
A Digital Health Intervention to Promote Self-management in Patients With Chronic Obstructive Pulmonary Disease
A study testing Digital health intervention by using a mobile application and Feasibilty study and qualitative interview studies in people with Chronic Obstructive Pulmonary Disease (COPD) and Self-management, run by Western Norway University of Applied Sciences at 1 site in Norway.
Trial summary
Dyspnea, cough, and chronic mucus hypersecretion are common symptoms in patients with Chronic Obstructive Pulmonary Disease (COPD), which increases risk of infections followed by exacerbations, often leading to hospitalization, disease progression and mortality. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Self-management, Mobile Application
- What is being tested?
- Digital health intervention by using a mobile application and Feasibilty study and qualitative interview studies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNorway
- Study dates
- 6 Jan 2025to 31 Dec 2030
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Chronic Obstructive Pulmonary Disease
- Mucus-related issues ≥3 times per week
- Speak and write Norwegian
- Ability to independently operate a smartphone and/or iPad
Who cannot join
- Severe mental illness
- Substance abuse that hinder participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Western Norway University of Applied Sciences
Bergen, Norway, 5063
Bente Frisk, PHD, 0047-55587143, bente.frisk@hvl.no
Siri Dahl Aune, MSc, 0047-46417431, siri.dahl.aune@hvl.no
About this study
Official title: A Digital Health Intervention for Promoting Self-management in Patients With Chronic Obstructive Pulmonary Disease - a Feasibility Study
Dyspnea, cough, and chronic mucus hypersecretion are common symptoms in patients with Chronic Obstructive Pulmonary Disease (COPD), which increases risk of infections followed by exacerbations, often leading to hospitalization, disease progression and mortality. This patient group requires lifelong treatment in healthcare. A mobile application was developed to facilitate adherence to evidence-based guidelines for tailored breathing and airway clearance techniques to enhance self-management. The app is only in Norwegian and has a Norwegian name which is "Pust Deg Bedre" (PDB). The PDB app is fully developed and tested and can be downloaded for free. The app seems promising as a treatment tool, but has not yet been clinical evaluated. This project aims to 1) explore the feasibility of providing the app for patients with COPD, 2) explore the patients' with COPD experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 3) explore the physiotherapists' experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 4) explore the physiotherapists' experiences with implementing the PDB-app in treatment of patients with COPD, 5) explore the patients' experiences with the education in use of the PDB-app, and 6) At a 6-month follow up: explore the physiotherapists experiences with the usefulness and applicability of PBD-app, and to generally explore their experiences with participating in the project.
Read the detailed description
This project is designed to explore aspects of acceptability and possible uncertainties associated with implementing the PDB-app as part of self-management in patients with COPD. Both quantitative and qualitative data will be collected and analysed.
50-60 patients with COPD and 15-30 physiotherapists in primary health care will be recruited.
A feasibility study will be conducted and evaluated after 8-week intervention and at 6-month follow-up, using a pre-post design.
Intervention: The physiotherapists will be responsible for providing the patients with training on the use of the PDB-app. Based on clinical assessment, the patients will receive a tailored treatment plan within the app. Patients are expected to engage with the tailored PDB-treatment for 8 weeks with follow-up after 6 months. If necessarily, adjustments to the treatment plan will be made throughout the intervention period. Follow-up of patients will occur digitally and physically.
A qualitative interview study will be conducted with semi-structured interviews after 8 weeks of intervention for a deeper understanding of the patients' and physiotherapists' experiences with the PDB-app. Separate focus groups will be conducted with the patients and the physiotherapists.
The investigators will also conduct video-recorded physiotherapy sessions at two time points during the intervention. The first one during the initial session, and then again between 3 to 6 weeks during the 8-week intervention. Subsequently, in-depth interviews, using Interpersonal Process Recall (IPR), will be conducted, with the researcher and physiotherapist, and with the researcher and patient. By using IPR interviews, video-assisted recall will help research participants access underlying experiences of their recent clinical interactions and put them into words. This means that the interaction between patient, physiotherapist and the PDB-app, experienced and recalled in the interview, relates to concrete events of the specific session.
Targeting physiotherapists, the investigators aim to do a long-term follow up 6 months after the intervention and explore their experiences with having participated in IPR interviews and as participants in the study in general. How and to what degree has the IPR interview sessions and the experiences from participating in this project impacted on their clinical practice, perception of role, identity and lifeworld? The investigators will conduct individual semi-structured qualitative interviews with all the physiotherapists from the IPR interviews.
Criteria for success:
- At least 80% of the patients complete the intervention and the questionnaires after 8-weeks
- At least 80% of the patients' complete questionnaires at 6-month follow-up
- At least 90% of physiotherapists complete the study period
- No adverse events by using the PDB-app
- Patient satisfaction score measured with CSQ-8 ≥20 (indicate good satisfaction)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Self-management, Mobile Application, Feasibility Studies
- Being tested
- Digital health intervention by using a mobile application, Feasibilty study and qualitative interview studies
- Keywords
- COPD, Digital health intervention, Feasibility, Self-management, Mobile Application
- 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 health intervention by using a mobile applicationDevice
A digital health intervention for promoting self-management in patients with COPD by using a mobile application.
Feasibilty study and qualitative interview studiesOther
This study is a one group feasibility study including quantitative and qualitative study designs. The investigators will use focus groups and indiviual interviews, as well as Interpersonal Process Recall (IPR) interviews.
| Study group | Role | What they receive |
|---|---|---|
| Digital health intervention group | Experimental | Patients with COPD will use the mobile-app in self-management of treating dyspnea and mucus secretion. Receives: Device: Digital health intervention by using a mobile application; Other: Feasibilty study and qualitative interview studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate (n, %)
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Intervention adherence
Intervention adherence (n, %)
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Adverse events
Adverse events (n, %)
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Dropout rate
Dropout (n, %)
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health related outcomes
- Dyspnea-12 (D-12) scale score (score 0-36) - low score indicates better outcome
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health related outcomes
Modified Medical Research Council dyspnea scale (mMRC) (score 0-4) - low score indicates better outcome
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health related outcomes
Chalder Fatigue Scale (CFQ-11) (score 0-33) - low score indicates better outcome
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health related outcomes
COPD Assessment Test (CAT) (score 0-40) - low score indicates better outcome
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health related outcome
Generalized Anxiety Disorder Assessment (GAD-7) (score 0-21) - low score indicates better outcome
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health related outcome
Patient Health Questionnaire-9 (PHQ-9) (score 0-27) - low score indicates better outcome
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health related outcomes
Patient Health Questionnaire-9 (PHQ-9) (score 0-27) - low score indicates better outcome
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health related outcomes
EuroQol Questionnaire (EQ-5D) (index and VAS score 0-100) Index: An overall score is generated, ranging from <0 to 1. Low score indicates worse outcome VAS score: low score indicates worse outcome
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Physical functioning
60 seconds Sit-To-Stand (60sSTS) (number of repetitions) - Higher number of repetitions indicates better outcome
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Exacerbations, hospital admissions and use of healthcare services
The number of exacerbations, hospital admissions and use of healthcare services (n)
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health literacy
Health Literacy Questionnaire (HLQ) (44 items, 9 domains) - Health literacy was measured using three domains of the HLQ; 3) Actively managing my health, 6) Ability to engage actively with health-care providers and 9) Understand health information well enough to know what to do. Domains 1-5 are scored 1-4, and domains 6-9 are scored 1-5. Lower score indicates lower levels of health literacy.
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health literacy
E-Health Literacy Questionnaire (e-HLQ) (35 items, 7 domains) - E-Health literachy was measured using two domains of the e-HLQ; 3) Ability to actively engage with digital services and 5) Motivated to engage with digital services. Scores range from 1-4. Lower score indicates lower levels of e-Health literacy.
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health education and self-management
Health Education Impact Questionnaire (heiQ) (48 items, 8 domains) - is used to measure helath edcuation and self-management. We are using three domains of the heiQ; 2) Health related behaviour, 3) Skill and technique acquisition and 5) Self-monitoring and insight. Scores ranges from 1-4. Lower score indicates lower levels of health education impact and self-management.
Measured: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Satisfaction with treatment
Patients Global Impression of Change (PGIC) (score 0-7) - low score indicates better outcome
Measured: End of treatment at 8 weeks and the end of treatment at 6-month follow-up
Satisfaction with treatment
Client Satisfaction Questionnaire (CSQ-8) (score 8-32) - low score indicates worse outcome
Measured: End of treatment at 8 weeks and the end of treatment at 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start6 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators will use the mobile app "Pust Deg Bedre" to explore the feasibility and experiences of providing PDB for patients with COPD,
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Forde
- Responsible party
- Principal investigator, Bente Frisk, Western Norway University of Applied Sciences
- Investigators
- Bente Frisk, PHD, Principal investigator, Western Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850961
- Sponsor's protocol ID
- REK2024/733856
- Other IDs
- REK2024/733856
- Status last verified
- Feb 2025
- First submitted
- 2 Dec 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the approvals granted for this study by the Regional Committee on Medical Research Ethics and the Norwegian Data Inspectorate, the data files will be stored securely and in accordance with the Norwegian Law of Privacy Protection. A subset of the data file with anonymized data will be made available to interested researchers upon reasonable request to Bente Frisk: bente.frisk@hvl.no, providing that Norwegian privacy legislation and the General Data Protection Regulation are respected, and that permission is granted from the Norwegian Data Inspectorate and the data protection officer at Western Norway University of Applied Sciences.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Health Intervention for Promoting Self-management in Patients With Chronic Obstructive Pulmonary Disease - a Feasibility Study
- ClinicalTrials.gov ID
- NCT06850961
- Acronym / sponsor ID
- REK2024/733856
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Self-management, Mobile Application, Feasibility Studies
- Keywords
- COPD, Digital health intervention, Feasibility, Self-management, Mobile Application
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Western Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- Helse Forde
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Feb 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.
Dyspnea, cough, and chronic mucus hypersecretion are common symptoms in patients with Chronic Obstructive Pulmonary Disease (COPD), which increases risk of infections followed by exacerbations, often leading to hospitalization, disease progression and mortality. This patient group requires lifelong treatment in healthcare. A mobile application was developed to facilitate adherence to evidence-based guidelines for tailored breathing and airway clearance techniques to enhance self-management. The app is only in Norwegian and has a Norwegian name which is "Pust Deg Bedre" (PDB). The PDB app is fully developed and tested and can be downloaded for free. The app seems promising as a treatment tool, but has not yet been clinical evaluated. This project aims to 1) explore the feasibility of providing the app for patients with COPD, 2) explore the patients' with COPD experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 3) explore the physiotherapists' experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 4) explore the physiotherapists' experiences with implementing the PDB-app in treatment of patients with COPD, 5) explore the patients' experiences with the education in use of the PDB-app, and 6) At a 6-month follow up: explore the physiotherapists experiences with the usefulness and applicability of PBD-app, and to generally explore their experiences with participating in the project.
Detailed description
This project is designed to explore aspects of acceptability and possible uncertainties associated with implementing the PDB-app as part of self-management in patients with COPD. Both quantitative and qualitative data will be collected and analysed.
50-60 patients with COPD and 15-30 physiotherapists in primary health care will be recruited.
A feasibility study will be conducted and evaluated after 8-week intervention and at 6-month follow-up, using a pre-post design.
Intervention: The physiotherapists will be responsible for providing the patients with training on the use of the PDB-app. Based on clinical assessment, the patients will receive a tailored treatment plan within the app. Patients are expected to engage with the tailored PDB-treatment for 8 weeks with follow-up after 6 months. If necessarily, adjustments to the treatment plan will be made throughout the intervention period. Follow-up of patients will occur digitally and physically.
A qualitative interview study will be conducted with semi-structured interviews after 8 weeks of intervention for a deeper understanding of the patients' and physiotherapists' experiences with the PDB-app. Separate focus groups will be conducted with the patients and the physiotherapists.
The investigators will also conduct video-recorded physiotherapy sessions at two time points during the intervention. The first one during the initial session, and then again between 3 to 6 weeks during the 8-week intervention. Subsequently, in-depth interviews, using Interpersonal Process Recall (IPR), will be conducted, with the researcher and physiotherapist, and with the researcher and patient. By using IPR interviews, video-assisted recall will help research participants access underlying experiences of their recent clinical interactions and put them into words. This means that the interaction between patient, physiotherapist and the PDB-app, experienced and recalled in the interview, relates to concrete events of the specific session.
Targeting physiotherapists, the investigators aim to do a long-term follow up 6 months after the intervention and explore their experiences with having participated in IPR interviews and as participants in the study in general. How and to what degree has the IPR interview sessions and the experiences from participating in this project impacted on their clinical practice, perception of role, identity and lifeworld? The investigators will conduct individual semi-structured qualitative interviews with all the physiotherapists from the IPR interviews.
Criteria for success:
- At least 80% of the patients complete the intervention and the questionnaires after 8-weeks
- At least 80% of the patients' complete questionnaires at 6-month follow-up
- At least 90% of physiotherapists complete the study period
- No adverse events by using the PDB-app
- Patient satisfaction score measured with CSQ-8 ≥20 (indicate good satisfaction)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators will use the mobile app "Pust Deg Bedre" to explore the feasibility and experiences of providing PDB for patients with COPD,
| Arm | Type | Receives |
|---|---|---|
| Digital health intervention group | Experimental | Device: Digital health intervention by using a mobile application, Other: Feasibilty study and qualitative interview studiesPatients with COPD will use the mobile-app in self-management of treating dyspnea and mucus secretion. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Chronic Obstructive Pulmonary Disease
- Mucus-related issues ≥3 times per week
- Speak and write Norwegian
- Ability to independently operate a smartphone and/or iPad
Key exclusion criteria (2 listed)
- Severe mental illness
- Substance abuse that hinder participation in the 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 |
|---|---|---|
| Digital health intervention by using a mobile applicationA digital health intervention for promoting self-management in patients with COPD by using a mobile application. | Device | Digital health intervention group |
| Feasibilty study and qualitative interview studiesThis study is a one group feasibility study including quantitative and qualitative study designs. The investigators will use focus groups and indiviual interviews, as well as Interpersonal Process Recall (IPR) interviews. | Other | Digital health intervention group |
Primary outcome
Recruitment rate
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Recruitment rate (n, %)
Intervention adherence
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Intervention adherence (n, %)
Adverse events
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Adverse events (n, %)
Dropout rate
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Dropout (n, %)
Health related outcomes
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
- Dyspnea-12 (D-12) scale score (score 0-36) - low score indicates better outcome
Health related outcomes
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Modified Medical Research Council dyspnea scale (mMRC) (score 0-4) - low score indicates better outcome
Health related outcomes
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Chalder Fatigue Scale (CFQ-11) (score 0-33) - low score indicates better outcome
Health related outcomes
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
COPD Assessment Test (CAT) (score 0-40) - low score indicates better outcome
Health related outcome
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Generalized Anxiety Disorder Assessment (GAD-7) (score 0-21) - low score indicates better outcome
Health related outcome
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Patient Health Questionnaire-9 (PHQ-9) (score 0-27) - low score indicates better outcome
Health related outcomes
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Patient Health Questionnaire-9 (PHQ-9) (score 0-27) - low score indicates better outcome
Health related outcomes
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
EuroQol Questionnaire (EQ-5D) (index and VAS score 0-100) Index: An overall score is generated, ranging from <0 to 1. Low score indicates worse outcome VAS score: low score indicates worse outcome
Physical functioning
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
60 seconds Sit-To-Stand (60sSTS) (number of repetitions) - Higher number of repetitions indicates better outcome
Exacerbations, hospital admissions and use of healthcare services
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
The number of exacerbations, hospital admissions and use of healthcare services (n)
Health literacy
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health Literacy Questionnaire (HLQ) (44 items, 9 domains) - Health literacy was measured using three domains of the HLQ; 3) Actively managing my health, 6) Ability to engage actively with health-care providers and 9) Understand health information well enough to know what to do. Domains 1-5 are scored 1-4, and domains 6-9 are scored 1-5. Lower score indicates lower levels of health literacy.
Health literacy
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
E-Health Literacy Questionnaire (e-HLQ) (35 items, 7 domains) - E-Health literachy was measured using two domains of the e-HLQ; 3) Ability to actively engage with digital services and 5) Motivated to engage with digital services. Scores range from 1-4. Lower score indicates lower levels of e-Health literacy.
Health education and self-management
Time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
Health Education Impact Questionnaire (heiQ) (48 items, 8 domains) - is used to measure helath edcuation and self-management. We are using three domains of the heiQ; 2) Health related behaviour, 3) Skill and technique acquisition and 5) Self-monitoring and insight. Scores ranges from 1-4. Lower score indicates lower levels of health education impact and self-management.
Satisfaction with treatment
Time frame: End of treatment at 8 weeks and the end of treatment at 6-month follow-up
Patients Global Impression of Change (PGIC) (score 0-7) - low score indicates better outcome
Satisfaction with treatment
Time frame: End of treatment at 8 weeks and the end of treatment at 6-month follow-up
Client Satisfaction Questionnaire (CSQ-8) (score 8-32) - low score indicates worse outcome
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 28 Feb 2025.
- Individual participant dataSharing planned: Yes. In accordance with the approvals granted for this study by the Regional Committee on Medical Research Ethics and the Norwegian Data Inspectorate, the data files will be stored securely and in accordance with the Norwegian Law of Privacy Protection. A subset of the data file with anonymized data will be made available to interested researchers upon reasonable request to Bente Frisk: bente.frisk@hvl.no, providing that Norwegian privacy legislation and the General Data Protection Regulation are respected, and that permission is granted from the Norwegian Data Inspectorate and the data protection officer at Western Norway University of Applied Sciences.
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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.
Bente Frisk, PHD principal investigator
Western Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital health intervention by using a mobile application and Feasibilty study and qualitative interview studies in people with Chronic Obstructive Pulmonary Disease (COPD) and Self-management, run by Western Norway University of Applied Sciences at 1 site in Norway.
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 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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 Norway. 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?
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?
Contact Bente Frisk, PHD (0047- 55587143, bente.frisk@hvl.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up). The study lists 19 primary outcomes in all. 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 28 Feb 2025.