Pulmonary Disease, Chronic ObstructiveNCT02696187
Feasibility and Effects of KOL-webben in Patients With COPD
A study testing KOLwebben in people with Pulmonary Disease, Chronic Obstructive, run by Umeå University at 1 site in Sweden.
Trial summary
This study evaluates the effects of KOL-webben (the COPD web), an interactive web-based system directed towards two target groups; people with chronic obstructive pulmonary disease (COPD) and health professionals in primary care. 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?
- KOLwebben
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSweden
- Study dates
- 21 Jan 2016to 15 Mar 2018
- 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
- Adults 40 years and above diagnosed with COPD according to GOLD criteria i.e. Forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) < 0.70.
- Needs to understand Swedish or have access to anyone who understands Swedish.
Who cannot join
- Not COPD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effects of KOL-webben - an Internet Based Health Promotion Tool Directed Towards People With Chronic Obstructive Pulmonary Disease and Staff in the Primary Health Care in Sweden
This study evaluates the effects of KOL-webben (the COPD web), an interactive web-based system directed towards two target groups; people with chronic obstructive pulmonary disease (COPD) and health professionals in primary care. KOL-webben include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. Moreover, KOL-webben include knowledge and tools directed towards staff in the primary care aimed to implement provision of evidence based health promotion interventions.The feasibility and effects of KOL-webben will be evaluated.
Read the detailed description
Pulmonary rehabilitation is a cornerstone in the management of patients with chronic obstructive pulmonary disease (COPD) and includes self-management strategies and exercise training. Pulmonary rehabilitation has been shown to decrease dyspnea, improve physical capacity, level of physical activity and health-related quality of life. Traditionally patients with COPD have been treated at pulmonary or medical departments in hospitals. However, due to changes in the Swedish health system these patients now are mainly treated in primary care. Though, the pulmonary rehabilitation programs are still mainly offered by hospitals.
Our research group performed a survey in all hospitals treating patients with COPD in Sweden. The investigators found that less than a half percent of the COPD population took part in pulmonary rehabilitation in 2011. Moreover, a recent survey study performed in Swedish primary care settings found that physiotherapists were available for patients with COPD which is positive. However, only 10 % of the patients with COPD have had access to physiotherapy for their disease. Consequently there is an urgent need to find new strategies to facilitate the provision of pulmonary rehabilitation in the primary care and to provide to people with COPD.
The components included in pulmonary rehabilitation can be considered as health promotion intervention. Health promotion interventions are an important part of the primary care's assignment/mission in Sweden and in order to stress the responsibility for these interventions directed to people with COPD, we have chosen to use the term health promotion interventions instead of pulmonary rehabilitation. Even though there is strong scientific evidence for beneficial effects of health promoting interventions including physical exercise and self-management strategies, a very limited proportion of the people with COPD get access to such services in the primary care. There is an obvious need to find ways to implement available knowledge in clinical practice. Accordingly, KOL-webben is developed as a method (measure/tool) to implement evidence based health promotion interventions and to facilitate the delivery of such services to people with COPD. KOL-webben is also developed as a tool that will support self-management including health promotion among people with COPD.
The design of the explorative feasibility study will be an controlled study with a baseline assessment, delivery of the intervention during 3 months and a follow-up at two month after the completion of the delivery. In order to explore best practice, the usefulness and the effect of the intervention, the feasibility of the data collection and recruitment of people with COPD, a process evaluation will be carried out.Two primary health care units in the county council of Västerbotten in northern Sweden and four primary units in the county council of Dalarna in Mid Sweden will be included in the study. The units will represent both rural and urban settings.
KOL-webben is an interactive web-based system directed towards two target groups; people with COPD and health care professionals. The section directed towards people with COPD will provide tools that improve health literacy and thereby promote and enable a healthier lifestyle with a specific focus on 1) increased physical activity and 2) use appropriate self-management strategies. The tools include educational material, use of (e.g. texts, images, movies, web-links) and interactive components (e.g. ability to report steps per day and symptoms with feedback) adapted to the different stages of the disease. The section directed towards health care professionals includes tools that aim to improve the knowledge, attitudes and confidence in providing evidence based health promotion interventions. The tools include easily accessible knowledge and material (e.g. movies, screening tests, images, power point presentation for patient education and exercise programs).The control group will be recruited from the same health care units among listed patients with no planned visit within the 3 month intervention period. The control group will not receive any intervention.
- All persons with COPD who visits the primary care centre during the study period will constitute the sample in the intervention group (KOL-webben).
- The control group will be recruited from the same primary health care units among listed patients with no planned visit within the 3 month intervention period
- A subgroup of 40 persons (8 from each unit) will be included in additional assessment according to the following: measure of physical activity, measure of physical activity and the process evaluation, or the process evaluation alone. The subgroup will be consecutively recruited among those who visit the primary care centres. Measures of physical activity will also be made in a similar size subgroup of participants in the control group.
Before and after the three month intervention period effects on impact of COPD in daily life, health literacy, confidence in managing their COPD, aspects of physical activity, self-efficacy to perform physical activity, quality of life, dyspnea and level of physical activity will be collected. In addition will we determine effects on instrumental and conceptual knowledge among health professionals
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- KOLwebben
- Keywords
- Pulmonary Disease, Chronic Obstructive, Feasibility, Health promotion tool, Self management, Evidence based care, Knowledge transfer, 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.
KOLwebbenBehavioural
KOL-webben will be introduced to all people with COPD during their ordinary visits to the primary care center during a 3 months period. The introduction to KOL-webben will be tailored to each person's needs and include 1) registration of the patient at KOL-webben 2) showing and discussing specific content on KOL-webben (e.g. movies with exercises if the person needs exercise training) chosen to meet the needs of the individual 3) giving a card (A5 format) with address to KOL-webben, user information and references to chosen content on KOL-webben. All patients will also receive a pedometer.
| Study group | Role | What they receive |
|---|---|---|
| KOLwebben | Experimental | Patients in the experimental group will be introduced to KOL-webben during their ordinary visits to the primary care center. All patients will receive a pedometer Receives: Behavioral: KOLwebben |
| Control group | No intervention | Other than receiving a pedometer 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 impact of COPD in daily life
Impact of COPD in daily life will be assessed using the COPD assessment test.
Measured: Baseline and 3 months after baseline
Secondary outcomes (10)
Change in health literacy
Health literacy will be assessed using the Swedish C \& C HL Scale.
Measured: Baseline and 3 months after baseline
Change in confidence in managing their COPD
Confidence in managing their COPD will be assessed using questions specifically developed for this study (face validity will be tested)
Measured: Baseline and 3 months after baseline
Change in aspects of physical activity
Aspects of physical activity will be assessed using the Grimby's Activity Scale
Measured: Baseline and 3 months after baseline
Change in aspects of physical activity
Aspects of physical activity will be assessed using indicators about physical activity retrieved from the National Board of Health and Welfare
Measured: Baseline and 3 months after baseline
Change in self-efficacy to perform physical activity
Self-efficacy to perform physical activity will be assessed using The SCI Exercise Self-Efficacy Scale (ESES).
Measured: Baseline and 3 months after baseline
Change in quality of life
Quality of life will be assessed using the EQ5D.
Measured: Baseline and 3 months after baseline
Change in dyspnea severity
Dyspnea severity will be assessed using the Medical Research Council Scale.
Measured: Baseline and 3 months after baseline
Change in level of physical activity
Level of physical activity will be measured with an activity monitor, the DynaPort MiniMod. The activity monitor data collected during 7 Days at baseline and 7 Days 3 months after baseline will be used to assess change in level of physical activity.
Measured: 7 Days at baseline and and 7 days at 3 months after baseline
Change in instrumental knowledge among health professionals
Instrumental knowledge use of evidence based health promotion interventions will be assessed through a review of medical records; a baseline review of medical record of patients with a COPD diagnosis who have visited the primary care centre during August and September 2015 will be performed and a follow-up review will be performed after the end of the study period.
Measured: Baseline and 3 months after baseline
Change in conceptual knowledge among health professionals
Conceptual knowledge use (i.e. knowledge, attitudes, and intentions) will be assessed using a questionnaire including both structured and semi-structured questions at baseline and at follow-up
Measured: Baseline and 3 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 posted2 Mar 2016 (estimated)
- Study start21 Jan 2016
- Primary completion15 May 2017
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Umeå 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 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 UniversityAndre Nyberg, PhD, Study director, Umeå UniversityMalin Tistad, PhD, Study director, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696187
- Sponsor's protocol ID
- KOLwebben
- Status last verified
- May 2018
- First submitted
- 14 Jan 2016
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nyberg A, Sondell A, Lundell S, Marklund S, Tistad M, Wadell K. Experiences of Using an Electronic Health Tool Among Health Care Professionals Involved in Chronic Obstructive Pulmonary Disease Management: Qualitative Analysis. JMIR Hum Factors. 2023 Mar 30;10:e43269. doi: 10.2196/43269.
PubMed 36995743Marklund S, Tistad M, Lundell S, Ostrand L, Sorlin A, Bostrom C, Wadell K, Nyberg A. Experiences and Factors Affecting Usage of an eHealth Tool for Self-Management Among People With Chronic Obstructive Pulmonary Disease: Qualitative Study. J Med Internet Res. 2021 Apr 30;23(4):e25672. doi: 10.2196/25672.
PubMed 33929327Nyberg A, Wadell K, Lindgren H, Tistad M. Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare. BMJ Open. 2017 Aug 1;7(7):e016851. doi: 10.1136/bmjopen-2017-016851.
PubMed 28765136
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effects of KOL-webben - an Internet Based Health Promotion Tool Directed Towards People With Chronic Obstructive Pulmonary Disease and Staff in the Primary Health Care in Sweden
- ClinicalTrials.gov ID
- NCT02696187
- Acronym / sponsor ID
- KOLwebben
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Feasibility, Health promotion tool, Self management, Evidence based care, Knowledge transfer, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 2 Mar 2016 (estimated)
- 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 KOL-webben (the COPD web), an interactive web-based system directed towards two target groups; people with chronic obstructive pulmonary disease (COPD) and health professionals in primary care. KOL-webben include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. Moreover, KOL-webben include knowledge and tools directed towards staff in the primary care aimed to implement provision of evidence based health promotion interventions.The feasibility and effects of KOL-webben will be evaluated.
Detailed description
Pulmonary rehabilitation is a cornerstone in the management of patients with chronic obstructive pulmonary disease (COPD) and includes self-management strategies and exercise training. Pulmonary rehabilitation has been shown to decrease dyspnea, improve physical capacity, level of physical activity and health-related quality of life. Traditionally patients with COPD have been treated at pulmonary or medical departments in hospitals. However, due to changes in the Swedish health system these patients now are mainly treated in primary care. Though, the pulmonary rehabilitation programs are still mainly offered by hospitals.
Our research group performed a survey in all hospitals treating patients with COPD in Sweden. The investigators found that less than a half percent of the COPD population took part in pulmonary rehabilitation in 2011. Moreover, a recent survey study performed in Swedish primary care settings found that physiotherapists were available for patients with COPD which is positive. However, only 10 % of the patients with COPD have had access to physiotherapy for their disease. Consequently there is an urgent need to find new strategies to facilitate the provision of pulmonary rehabilitation in the primary care and to provide to people with COPD.
The components included in pulmonary rehabilitation can be considered as health promotion intervention. Health promotion interventions are an important part of the primary care's assignment/mission in Sweden and in order to stress the responsibility for these interventions directed to people with COPD, we have chosen to use the term health promotion interventions instead of pulmonary rehabilitation. Even though there is strong scientific evidence for beneficial effects of health promoting interventions including physical exercise and self-management strategies, a very limited proportion of the people with COPD get access to such services in the primary care. There is an obvious need to find ways to implement available knowledge in clinical practice. Accordingly, KOL-webben is developed as a method (measure/tool) to implement evidence based health promotion interventions and to facilitate the delivery of such services to people with COPD. KOL-webben is also developed as a tool that will support self-management including health promotion among people with COPD.
The design of the explorative feasibility study will be an controlled study with a baseline assessment, delivery of the intervention during 3 months and a follow-up at two month after the completion of the delivery. In order to explore best practice, the usefulness and the effect of the intervention, the feasibility of the data collection and recruitment of people with COPD, a process evaluation will be carried out.Two primary health care units in the county council of Västerbotten in northern Sweden and four primary units in the county council of Dalarna in Mid Sweden will be included in the study. The units will represent both rural and urban settings.
KOL-webben is an interactive web-based system directed towards two target groups; people with COPD and health care professionals. The section directed towards people with COPD will provide tools that improve health literacy and thereby promote and enable a healthier lifestyle with a specific focus on 1) increased physical activity and 2) use appropriate self-management strategies. The tools include educational material, use of (e.g. texts, images, movies, web-links) and interactive components (e.g. ability to report steps per day and symptoms with feedback) adapted to the different stages of the disease. The section directed towards health care professionals includes tools that aim to improve the knowledge, attitudes and confidence in providing evidence based health promotion interventions. The tools include easily accessible knowledge and material (e.g. movies, screening tests, images, power point presentation for patient education and exercise programs).The control group will be recruited from the same health care units among listed patients with no planned visit within the 3 month intervention period. The control group will not receive any intervention.
- All persons with COPD who visits the primary care centre during the study period will constitute the sample in the intervention group (KOL-webben).
- The control group will be recruited from the same primary health care units among listed patients with no planned visit within the 3 month intervention period
- A subgroup of 40 persons (8 from each unit) will be included in additional assessment according to the following: measure of physical activity, measure of physical activity and the process evaluation, or the process evaluation alone. The subgroup will be consecutively recruited among those who visit the primary care centres. Measures of physical activity will also be made in a similar size subgroup of participants in the control group.
Before and after the three month intervention period effects on impact of COPD in daily life, health literacy, confidence in managing their COPD, aspects of physical activity, self-efficacy to perform physical activity, quality of life, dyspnea and level of physical activity will be collected. In addition will we determine effects on instrumental and conceptual knowledge among health professionals
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KOLwebben | Experimental | Behavioral: KOLwebbenPatients in the experimental group will be introduced to KOL-webben during their ordinary visits to the primary care center. All patients will receive a pedometer |
| Control group | No intervention | –Other than receiving a pedometer 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 (2 listed)
- Adults 40 years and above diagnosed with COPD according to GOLD criteria i.e. Forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) < 0.70.
- Needs to understand Swedish or have access to anyone who understands Swedish.
Key exclusion criteria (1 listed)
- Not COPD
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 |
|---|---|---|
| KOLwebbenKOL-webben will be introduced to all people with COPD during their ordinary visits to the primary care center during a 3 months period. The introduction to KOL-webben will be tailored to each person's needs and include 1) registration of the patient at KOL-webben 2) showing and discussing specific content on KOL-webben (e.g. movies with exercises if the person needs exercise training) chosen to meet the needs of the individual 3) giving a card (A5 format) with address to KOL-webben, user information and references to chosen content on KOL-webben. All patients will also receive a pedometer. | Behavioural | KOLwebben |
Primary outcome
Change in impact of COPD in daily life
Time frame: Baseline and 3 months after baseline
Impact of COPD in daily life will be assessed using the COPD assessment test.
10 secondary outcomes
Change in health literacy
Time frame: Baseline and 3 months after baseline
Change in confidence in managing their COPD
Time frame: Baseline and 3 months after baseline
Change in aspects of physical activity
Time frame: Baseline and 3 months after baseline
Change in aspects of physical activity
Time frame: Baseline and 3 months after baseline
Change in self-efficacy to perform physical activity
Time frame: Baseline and 3 months after baseline
Change in quality of life
Time frame: Baseline and 3 months after baseline
Change in dyspnea severity
Time frame: Baseline and 3 months after baseline
Change in level of physical activity
Time frame: 7 Days at baseline and and 7 days at 3 months after baseline
Change in instrumental knowledge among health professionals
Time frame: Baseline and 3 months after baseline
Change in conceptual knowledge among health professionals
Time frame: Baseline and 3 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 5 Aug 2019.
- Derived from this study: PubMed 36995743Nyberg A, Sondell A, Lundell S, Marklund S, Tistad M, Wadell K. Experiences of Using an Electronic Health Tool Among Health Care Professionals Involved in Chronic Obstructive Pulmonary Disease Management: Qualitative Analysis. JMIR Hum Factors. 2023 Mar 30;10:e43269. doi: 10.2196/43269.
- Derived from this study: PubMed 33929327Marklund S, Tistad M, Lundell S, Ostrand L, Sorlin A, Bostrom C, Wadell K, Nyberg A. Experiences and Factors Affecting Usage of an eHealth Tool for Self-Management Among People With Chronic Obstructive Pulmonary Disease: Qualitative Study. J Med Internet Res. 2021 Apr 30;23(4):e25672. doi: 10.2196/25672.
- Derived from this study: PubMed 28765136Nyberg A, Wadell K, Lindgren H, Tistad M. Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare. BMJ Open. 2017 Aug 1;7(7):e016851. doi: 10.1136/bmjopen-2017-016851.
- 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
Andre Nyberg, PhD study director
Umeå University
Malin Tistad, 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 KOLwebben 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 2 inclusion and 1 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 5 Aug 2019. 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 impact of COPD in daily life (time frame: Baseline and 3 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 NCT02696187, which also lists 3 linked publications.
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 5 Aug 2019.