Clinical trial NCT03746873: Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Health promotion tool
Self management
Evidence based care
Implementation
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 146
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in level of objectively measured physical activity
timeFrame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Secondary outcomes:
measure: Change in level of subjectively assessed physical activity
timeFrame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
measure: Change in subjectively assessed dyspnea severity
timeFrame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
measure: Change in subjectively assessed COPD-related symptoms
timeFrame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
measure: Change in subjectively assessed health related quality of life
timeFrame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
measure: Change in health economics using subjectively assessed EQ-5D in combination with self-reported health care contacts
timeFrame: 7 Days at baseline, 7 days at 3- and 12- months after baseline
Other outcomes:
measure: Enablers and barriers for the use of COPD Web in order to change behavior.
timeFrame: 3 months after baseline
Locations:
city: Umeå
country: Sweden
facility: Umeå university
Study officials:
affiliation: Umeå University
name: Karin Wadell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Tobias Stenlund, PhD
role: STUDY_DIRECTOR
affiliation: Umeå University
name: André Nyberg, PhD
role: STUDY_DIRECTOR
affiliation: Umeå University
name: Sara Lundell, MSc
role: STUDY_DIRECTOR
References:
citation: 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.