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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Sweden1 site
  • Umeå university

    Umeå

Other trials in Sweden

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

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 groups in NCT02696187
Study groupRoleWhat they receive
KOLwebbenExperimentalPatients 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 groupNo interventionOther 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.

  1. 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)
  1. Change in health literacy

    Health literacy will be assessed using the Swedish C \& C HL Scale.

    Measured: Baseline and 3 months after baseline

  2. 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

  3. 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

  4. 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

  5. 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

  6. Change in quality of life

    Quality of life will be assessed using the EQ5D.

    Measured: Baseline and 3 months after baseline

  7. Change in dyspnea severity

    Dyspnea severity will be assessed using the Medical Research Council Scale.

    Measured: Baseline and 3 months after baseline

  8. 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

  9. 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

  10. 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.

  1. First posted2 Mar 2016 (estimated)
  2. Study start21 Jan 2016
  3. Primary completion15 May 2017
  4. Study completion15 Mar 2018

Resources

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)
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 36995743
  • Marklund 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 33929327
  • Nyberg 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

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.

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