Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD

NCT03746873 | Completed

• 1 other identifier: KOLwebben1
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Health promotion tool; Self management; Evidence based care; Implementation

Outcome Measures

Primary Outcomes (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.

  7 Days at baseline, 7 days at 3- and 12- months after baseline

Secondary Outcomes (5)

• Change in level of subjectively assessed physical activity

  7 Days at baseline, 7 days at 3- and 12- months after baseline

• Change in subjectively assessed dyspnea severity

  7 Days at baseline, 7 days at 3- and 12- months after baseline

• Change in subjectively assessed COPD-related symptoms

  7 Days at baseline, 7 days at 3- and 12- months after baseline

• Change in subjectively assessed health related quality of life

  7 Days at baseline, 7 days at 3- and 12- months after baseline

• Change in health economics using subjectively assessed EQ-5D in combination with self-reported health care contacts

  7 Days at baseline, 7 days at 3- and 12- months after baseline

Other Outcomes (1)

• Enablers and barriers for the use of COPD Web in order to change behavior.

  3 months after baseline

Study Arms (2)

COPD Web

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

COPD Web BEHAVIORAL

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).

COPD Web

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Umeå university

Umeå, Sweden

Location

Related Publications (1)

• 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.

  PMID: 31594889 BACKGROUND

Related Links

• The COPDwebb is the site that participants in the intervention group will get access to. The site is locked with password during the study. People otside the study may still use the site with password kol1.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karin Wadell, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

• Tobias Stenlund, PhD

  Umeå University

  STUDY DIRECTOR

• André Nyberg, PhD

  Umeå University

  STUDY DIRECTOR

• Sara Lundell, MSc

  Umeå University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 20, 2018
• Study Start: November 15, 2018
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)