Pulmonary Disease, Chronic ObstructiveCOPDNCT03746873
Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD
A study testing COPD Web in people with Pulmonary Disease, Chronic Obstructive, run by Umeå University at 1 site in Sweden.
Trial summary
This study evaluates the effects of the COPD Web (KOLwebben), an interactive web-based tool directed towards people with chronic obstructive pulmonary disease (COPD). The COPD Web include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- COPD Web
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2018to 8 Jun 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All persons with a diagnosis of COPD (ICD-10:J44:9) who visit included primary care units due to their COPD.
- Needs to understand and read Swedish.
- Needs to have a smartphone, tablet or computer with access to internet.
- In case of exacerbation, the participant has to wait at least 6 weeks after initiated pharmacological treatment, before being eligible in the study.
Who cannot join
- Not COPD
- Dementia or other psychiatric condition that can prevent understanding of the intervention.
- Serious comorbidity that can be considered as the contributing factor for limitation in physical activity.
- Has an account on the COPD Web.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Web-based Self-management Intervention to Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD, in Primary Care: A Protocol for a Randomized Controlled Clinical Trial
This study evaluates the effects of the COPD Web (KOLwebben), an interactive web-based tool directed towards people with chronic obstructive pulmonary disease (COPD). The COPD Web include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. This randomized clinical trial aims to generate evidence on the effect and usability of the COPD Web in a properly powered cohort of patients in primary care context.
Read the detailed description
COPD is a chronic and disabling disease with substantial morbidity and mortality. The disease is one of the top 5 leading causes of death worldwide and the high prevalence places a considerable burden on the health care system. The symptom burden of the disease; dyspnea, fatigue, impaired functional performance, decreased level of physical activity and quality of life in patients with COPD are not only a consequence of the underlying condition, but depend also on the patients' adaptation to the symptoms and their ability to manage their disabling disease.
Self-management strategies, including strategies to promote self-efficacy through increasing the patients' knowledge, skills and their confidence in successfully managing their chronic disease is therefore an important part of COPD management. Even though education and promotion of self-management strategies for patients with COPD could be performed independently using a case manager, it is often promoted through pulmonary rehabilitation. In this context self-management means supporting individuals in gaining personal care and health behavioral skills, and develops confidence in applying these skills in everyday life. Pulmonary rehabilitation has been shown to be cost effective and is recommended as treatment for people with mild to very severe COPD since regular physical activity reduces hospital admissions and mortality in COPD. Support for self-management and education is often promoted by an asthma/COPD-nurse through pulmonary rehabilitation. However, in Sweden only a limited proportion of patients with COPD get access to such services which is related to both structural as well as individual barriers. With regard to the former, both limited access to pulmonary rehabilitation as well as to relevant health professionals have recently been reported in Swedish primary care settings. Individual barriers for participation in pulmonary rehabilitation programs found among patients with COPD are lack in knowledge and insight in their diagnosis, transportation and changing health.
Consequently there is an urgent need to find new strategies to facilitate the provision of self-management support to patients with COPD. Electronic health (eHealth) solutions are a promising way of delivering health service, and has previously been used as an alternative way of delivering pulmonary rehabilitation to patients with COPD. However, even though eHealth solutions have been suggested to have the potential to deliver support for self-management in patients with COPD, effects are inconsistent and further research is warranted. Therefore, to further address this question, the research group have developed the COPD Web, a web-based tool aimed at facilitating support for self-management through increasing the patients' knowledge and skills. The COPD Web has been co-created together with health professionals, patients with COPD, their relatives and experts in pulmonary rehabilitation. The COPD Web includes, in addition to texts, pictures and films (e.g., how to perform exercise training, breathing techniques etc.) also interactive components, such as a tool for registration of steps per day with automatized feedback. In a pilot study on 83 patients the investigators found promising results showing increased self-reported level of physical activity that is of great interest since level of physical activity is the strongest predictor of mortality in COPD. However, the pilot study fell short in design, i.e the intervention was not randomized, and there were a lack of power and objective measurements. Still, studies evaluating whether an objective web-based tool as the COPD Web could be used to promote self-management strategies in order to support e.g. increased physical activity in patients with COPD are contradictory and so far no study has been performed in a Swedish context.
The design will be a randomized controlled clinical trial with a baseline assessment and 3- and 12-months follow up regarding effects on physical activity, health related quality of life, COPD related symptoms and health economics as a consequence of the use of the COPD Web. In addition will the investigators identify enablers and barriers for the use of an web-based solution like the COPD Web in order to change behavior. All persons with COPD who visits included primary care centres in Sweden, until a total of 144 participants are included will constitute the sample in the intervention (COPD Web) and control group.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- COPD Web
- Keywords
- Pulmonary Disease, Chronic Obstructive, Health promotion tool, Self management, Evidence based care, Implementation
- 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.
COPD WebBehavioural
The COPD Web will be introduced to the participant randomized to intervention by a letter containing a code to get access to the web site and how to create an account and login. At the web site there will be an instruction movie showing/ discussing specific content on the COPD Web. The web site will be self-managed. To secure that there is no technical or user problems participants will be contacted by a researcher the first week of intervention.
Participants will receive "push notifications" (email) with targeted information containing links to the COPD Web and reminder to register the number of steps walked during that week. The push notifications will come every week (week 1-12), every other week (week 12 to 24) and every fourth week (week 24-52).
| Study group | Role | What they receive |
|---|---|---|
| COPD Web | Experimental | Participants randomised to experimental group will be introduced to the COPD Web by a letter containing written information. All participants will receive a pedometer and written information about the importance of physical activity. Receives: Behavioral: COPD Web |
| Control | No intervention | Other than receiving a pedometer and written information about the importance of physical activity the patients in the control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of objectively measured physical activity
Level of physical activity will be objectively measured with an activity monitor, the DynaPort MiniMod. The activity monitor data collected during 7 Days at baseline and 7 Days 3- and 12- months after baseline will be used to assess change in level of physical activity.
Measured: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Secondary outcomes (5)
Change in level of subjectively assessed physical activity
Level of physical activity will be subjectively assessed with Socialstyrelsens indicator questions on physical activity.
Measured: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Change in subjectively assessed dyspnea severity
Dyspnea severity will be assessed using the modified Medical Research Council dyspnea scale (mMRC)
Measured: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Change in subjectively assessed COPD-related symptoms
Change in COPD-related symptoms will be assessed using the COPD assessment test (CAT).
Measured: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Change in subjectively assessed health related quality of life
Change in health related quality of life will be assessed using the Chronic Respiratory Questionnaire, self-administered (CRQ-SA)
Measured: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Change in health economics using subjectively assessed EQ-5D in combination with self-reported health care contacts
Evaluation of health economics will be done using EQ-5D in combination with the number of COPD-related health care contacts that will be self-reported.
Measured: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start15 Nov 2018
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
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 Pulmonary Disease, Chronic ObstructiveStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin Wadell, PhD, Principal investigator, Umeå UniversityTobias Stenlund, PhD, Study director, Umeå UniversityAndré Nyberg, PhD, Study director, Umeå UniversitySara Lundell, MSc, Study director, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746873
- Sponsor's protocol ID
- KOLwebben1
- Acronym
- COPD
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2018
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stenlund T, Nyberg A, Lundell S, Wadell K. Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial. BMJ Open. 2019 Oct 7;9(10):e030788. doi: 10.1136/bmjopen-2019-030788.
PubMed 31594889
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-based Self-management Intervention to Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD, in Primary Care: A Protocol for a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03746873
- Acronym / sponsor ID
- COPD / KOLwebben1
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Health promotion tool, Self management, Evidence based care, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 20 Nov 2018 (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.
This study evaluates the effects of the COPD Web (KOLwebben), an interactive web-based tool directed towards people with chronic obstructive pulmonary disease (COPD). The COPD Web include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. This randomized clinical trial aims to generate evidence on the effect and usability of the COPD Web in a properly powered cohort of patients in primary care context.
Detailed description
COPD is a chronic and disabling disease with substantial morbidity and mortality. The disease is one of the top 5 leading causes of death worldwide and the high prevalence places a considerable burden on the health care system. The symptom burden of the disease; dyspnea, fatigue, impaired functional performance, decreased level of physical activity and quality of life in patients with COPD are not only a consequence of the underlying condition, but depend also on the patients' adaptation to the symptoms and their ability to manage their disabling disease.
Self-management strategies, including strategies to promote self-efficacy through increasing the patients' knowledge, skills and their confidence in successfully managing their chronic disease is therefore an important part of COPD management. Even though education and promotion of self-management strategies for patients with COPD could be performed independently using a case manager, it is often promoted through pulmonary rehabilitation. In this context self-management means supporting individuals in gaining personal care and health behavioral skills, and develops confidence in applying these skills in everyday life. Pulmonary rehabilitation has been shown to be cost effective and is recommended as treatment for people with mild to very severe COPD since regular physical activity reduces hospital admissions and mortality in COPD. Support for self-management and education is often promoted by an asthma/COPD-nurse through pulmonary rehabilitation. However, in Sweden only a limited proportion of patients with COPD get access to such services which is related to both structural as well as individual barriers. With regard to the former, both limited access to pulmonary rehabilitation as well as to relevant health professionals have recently been reported in Swedish primary care settings. Individual barriers for participation in pulmonary rehabilitation programs found among patients with COPD are lack in knowledge and insight in their diagnosis, transportation and changing health.
Consequently there is an urgent need to find new strategies to facilitate the provision of self-management support to patients with COPD. Electronic health (eHealth) solutions are a promising way of delivering health service, and has previously been used as an alternative way of delivering pulmonary rehabilitation to patients with COPD. However, even though eHealth solutions have been suggested to have the potential to deliver support for self-management in patients with COPD, effects are inconsistent and further research is warranted. Therefore, to further address this question, the research group have developed the COPD Web, a web-based tool aimed at facilitating support for self-management through increasing the patients' knowledge and skills. The COPD Web has been co-created together with health professionals, patients with COPD, their relatives and experts in pulmonary rehabilitation. The COPD Web includes, in addition to texts, pictures and films (e.g., how to perform exercise training, breathing techniques etc.) also interactive components, such as a tool for registration of steps per day with automatized feedback. In a pilot study on 83 patients the investigators found promising results showing increased self-reported level of physical activity that is of great interest since level of physical activity is the strongest predictor of mortality in COPD. However, the pilot study fell short in design, i.e the intervention was not randomized, and there were a lack of power and objective measurements. Still, studies evaluating whether an objective web-based tool as the COPD Web could be used to promote self-management strategies in order to support e.g. increased physical activity in patients with COPD are contradictory and so far no study has been performed in a Swedish context.
The design will be a randomized controlled clinical trial with a baseline assessment and 3- and 12-months follow up regarding effects on physical activity, health related quality of life, COPD related symptoms and health economics as a consequence of the use of the COPD Web. In addition will the investigators identify enablers and barriers for the use of an web-based solution like the COPD Web in order to change behavior. All persons with COPD who visits included primary care centres in Sweden, until a total of 144 participants are included will constitute the sample in the intervention (COPD Web) and control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Web | Experimental | Behavioral: COPD WebParticipants randomised to experimental group will be introduced to the COPD Web by a letter containing written information. All participants will receive a pedometer and written information about the importance of physical activity. |
| Control | No intervention | –Other than receiving a pedometer and written information about the importance of physical activity the patients in the control group will not receive any intervention. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All persons with a diagnosis of COPD (ICD-10:J44:9) who visit included primary care units due to their COPD.
- Needs to understand and read Swedish.
- Needs to have a smartphone, tablet or computer with access to internet.
- In case of exacerbation, the participant has to wait at least 6 weeks after initiated pharmacological treatment, before being eligible in the study.
Key exclusion criteria (4 listed)
- Not COPD
- Dementia or other psychiatric condition that can prevent understanding of the intervention.
- Serious comorbidity that can be considered as the contributing factor for limitation in physical activity.
- Has an account on the COPD Web.
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 |
|---|---|---|
| COPD WebThe COPD Web will be introduced to the participant randomized to intervention by a letter containing a code to get access to the web site and how to create an account and login. At the web site there will be an instruction movie showing/ discussing specific content on the COPD Web. The web site will be self-managed. To secure that there is no technical or user problems participants will be contacted by a researcher the first week of intervention. Participants will receive "push notifications" (email) with targeted information containing links to the COPD Web and reminder to register the number of steps walked during that week. The push notifications will come every week (week 1-12), every other week (week 12 to 24) and every fourth week (week 24-52). | Behavioural | COPD Web |
Primary outcome
Change in level of objectively measured physical activity
Time frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Level of physical activity will be objectively measured with an activity monitor, the DynaPort MiniMod. The activity monitor data collected during 7 Days at baseline and 7 Days 3- and 12- months after baseline will be used to assess change in level of physical activity.
5 secondary outcomes
Change in level of subjectively assessed physical activity
Time frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Change in subjectively assessed dyspnea severity
Time frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Change in subjectively assessed COPD-related symptoms
Time frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Change in subjectively assessed health related quality of life
Time frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Change in health economics using subjectively assessed EQ-5D in combination with self-reported health care contacts
Time frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
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 8 Dec 2023.
- Background: PubMed 31594889Stenlund T, Nyberg A, Lundell S, Wadell K. Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial. BMJ Open. 2019 Oct 7;9(10):e030788. doi: 10.1136/bmjopen-2019-030788.
- The COPDwebb is the site that participants in the intervention group will get access to. The site is locked with password during the study. People otside the study may still use the site with password kol1.Link provided by the sponsor.
- 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.
Karin Wadell, PhD principal investigator
Umeå University
Tobias Stenlund, PhD study director
Umeå University
André Nyberg, PhD study director
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPD Web in people with Pulmonary Disease, Chronic Obstructive, run by Umeå 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 8 Dec 2023. 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?
Change in level of objectively measured physical activity (time frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline). 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 NCT03746873, 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 8 Dec 2023.