Pulmonary Disease, Chronic Obstructive Clinical Trial
— COPDOfficial 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
Verified date | December 2023 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 146 |
Est. completion date | June 8, 2022 |
Est. primary completion date | June 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Umeå university | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University |
Sweden,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Enablers and barriers for the use of COPD Web in order to change behavior. | Semi structured interviews and content analysis will be performed in a subgroup of patients randomized to intervention to identify enablers and barriers for the use of an eHealth solution like COPD Web in order to change behavior. The patients will receive a question to take part in an interview at the 3 month follow up. | 3 months after baseline | |
Primary | 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. | 7 Days at baseline, 7 days at 3- and 12- months after baseline | |
Secondary | Change in level of subjectively assessed physical activity | Level of physical activity will be subjectively assessed with Socialstyrelsens indicator questions on physical activity. | 7 Days at baseline, 7 days at 3- and 12- months after baseline | |
Secondary | Change in subjectively assessed dyspnea severity | Dyspnea severity will be assessed using the modified Medical Research Council dyspnea scale (mMRC) | 7 Days at baseline, 7 days at 3- and 12- months after baseline | |
Secondary | Change in subjectively assessed COPD-related symptoms | Change in COPD-related symptoms will be assessed using the COPD assessment test (CAT). | 7 Days at baseline, 7 days at 3- and 12- months after baseline | |
Secondary | 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) | 7 Days at baseline, 7 days at 3- and 12- months after baseline | |
Secondary | 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. | 7 Days at baseline, 7 days at 3- and 12- months after baseline |
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