Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD (COPD)
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|ClinicalTrials.gov Identifier: NCT03746873|
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Behavioral: COPD Web||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||November 15, 2018|
|Estimated Primary Completion Date :||March 15, 2020|
|Estimated Study Completion Date :||March 15, 2020|
Experimental: COPD Web
Participants 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.
Behavioral: COPD Web
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).
No Intervention: Control
Other than receiving a pedometer and written information about the importance of physical activity the patients in the control group will not receive any intervention.
- Change in level of objectively measured physical activity [ Time Frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline ]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.
- Change in level of subjectively assessed physical activity [ Time Frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline ]Level of physical activity will be subjectively assessed with Socialstyrelsens indicator questions on physical activity.
- Change in subjectively assessed dyspnea severity [ Time Frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline ]Dyspnea severity will be assessed using the modified Medical Research Council dyspnea scale (mMRC)
- Change in subjectively assessed COPD-related symptoms [ Time Frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline ]Change in COPD-related symptoms will be assessed using the COPD assessment test (CAT).
- Change in subjectively assessed health related quality of life [ Time Frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline ]Change in health related quality of life will be assessed using the Chronic Respiratory Questionnaire, self-administered (CRQ-SA)
- Change in health economics using subjectively assessed EQ-5D in combination with self-reported health care contacts [ Time Frame: 7 Days at baseline, 7 days at 3- and 12- months after baseline ]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.
- Enablers and barriers for the use of COPD Web in order to change behavior. [ Time Frame: 3 months after baseline ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746873
|Contact: Tobias Stenlundemail@example.com|
|Contact: Karin Wadellfirstname.lastname@example.org|
|Contact: Karin Wadell|
|Principal Investigator:||Karin Wadell, PhD||Umeå University|
|Study Director:||Tobias Stenlund, PhD||Umeå University|
|Study Director:||André Nyberg, PhD||Umeå University|
|Study Director:||Sara Lundell, MSc||Umeå University|