AzTrials
AzTrials

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.

Completed

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

Official record
Search all trials

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
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.

Sweden1 site
  • Umeå university

    Umeå

Other trials in Sweden

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.

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 groups in NCT03746873
Study groupRoleWhat they receive
COPD WebExperimentalParticipants 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
ControlNo interventionOther 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted20 Nov 2018
  2. Study start15 Nov 2018
  3. Primary completion8 Jun 2022
  4. Study completion8 Jun 2022

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
146 participants (actual)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in