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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
Sponsor:
Information provided by (Responsible Party):
Umeå University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Behavioral: COPD Web Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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).

  4. 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)

  5. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746873


Contacts
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Contact: Tobias Stenlund +46907868040 tobias.stenlund@umu.se
Contact: Karin Wadell karin.wadell@umu.se

Locations
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Sweden
Umeå university Recruiting
Umeå, Sweden
Contact: Karin Wadell         
Sponsors and Collaborators
Umeå University
Investigators
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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

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03746873     History of Changes
Other Study ID Numbers: KOLwebben1
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Umeå University:
Pulmonary Disease, Chronic Obstructive
Health promotion tool
Self management
Evidence based care
Implementation

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive