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Feasibility and Effects of KOL-webben in Patients With COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
KOLwebben
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Feasibility, Health promotion tool, Self management, Evidence based care, Knowledge transfer, Implementation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults 40 years and above diagnosed with COPD according to GOLD criteria i.e. Forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) < 0.70.
  • Needs to understand Swedish or have access to anyone who understands Swedish.

Exclusion Criteria:

  • Not COPD

Sites / Locations

  • Umeå university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

KOLwebben

Control group

Arm Description

Patients in the experimental group will be introduced to KOL-webben during their ordinary visits to the primary care center. All patients will receive a pedometer

Other than receiving a pedometer the patients in the control group will not receive any intervention.

Outcomes

Primary Outcome Measures

Change in impact of COPD in daily life
Impact of COPD in daily life will be assessed using the COPD assessment test.

Secondary Outcome Measures

Change in health literacy
Health literacy will be assessed using the Swedish C & C HL Scale.
Change in confidence in managing their COPD
Confidence in managing their COPD will be assessed using questions specifically developed for this study (face validity will be tested)
Change in aspects of physical activity
Aspects of physical activity will be assessed using the Grimby's Activity Scale
Change in aspects of physical activity
Aspects of physical activity will be assessed using indicators about physical activity retrieved from the National Board of Health and Welfare
Change in self-efficacy to perform physical activity
Self-efficacy to perform physical activity will be assessed using The SCI Exercise Self-Efficacy Scale (ESES).
Change in quality of life
Quality of life will be assessed using the EQ5D.
Change in dyspnea severity
Dyspnea severity will be assessed using the Medical Research Council Scale.
Change in level of physical activity
Level of physical activity will be measured with an activity monitor, the DynaPort MiniMod. The activity monitor data collected during 7 Days at baseline and 7 Days 3 months after baseline will be used to assess change in level of physical activity.
Change in instrumental knowledge among health professionals
Instrumental knowledge use of evidence based health promotion interventions will be assessed through a review of medical records; a baseline review of medical record of patients with a COPD diagnosis who have visited the primary care centre during August and September 2015 will be performed and a follow-up review will be performed after the end of the study period.
Change in conceptual knowledge among health professionals
Conceptual knowledge use (i.e. knowledge, attitudes, and intentions) will be assessed using a questionnaire including both structured and semi-structured questions at baseline and at follow-up

Full Information

First Posted
January 14, 2016
Last Updated
August 1, 2019
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT02696187
Brief Title
Feasibility and Effects of KOL-webben in Patients With COPD
Official Title
Feasibility and Effects of KOL-webben - an Internet Based Health Promotion Tool Directed Towards People With Chronic Obstructive Pulmonary Disease and Staff in the Primary Health Care in Sweden
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 21, 2016 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effects of KOL-webben (the COPD web), an interactive web-based system directed towards two target groups; people with chronic obstructive pulmonary disease (COPD) and health professionals in primary care. KOL-webben include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. Moreover, KOL-webben include knowledge and tools directed towards staff in the primary care aimed to implement provision of evidence based health promotion interventions.The feasibility and effects of KOL-webben will be evaluated.
Detailed Description
Pulmonary rehabilitation is a cornerstone in the management of patients with chronic obstructive pulmonary disease (COPD) and includes self-management strategies and exercise training. Pulmonary rehabilitation has been shown to decrease dyspnea, improve physical capacity, level of physical activity and health-related quality of life. Traditionally patients with COPD have been treated at pulmonary or medical departments in hospitals. However, due to changes in the Swedish health system these patients now are mainly treated in primary care. Though, the pulmonary rehabilitation programs are still mainly offered by hospitals. Our research group performed a survey in all hospitals treating patients with COPD in Sweden. The investigators found that less than a half percent of the COPD population took part in pulmonary rehabilitation in 2011. Moreover, a recent survey study performed in Swedish primary care settings found that physiotherapists were available for patients with COPD which is positive. However, only 10 % of the patients with COPD have had access to physiotherapy for their disease. Consequently there is an urgent need to find new strategies to facilitate the provision of pulmonary rehabilitation in the primary care and to provide to people with COPD. The components included in pulmonary rehabilitation can be considered as health promotion intervention. Health promotion interventions are an important part of the primary care's assignment/mission in Sweden and in order to stress the responsibility for these interventions directed to people with COPD, we have chosen to use the term health promotion interventions instead of pulmonary rehabilitation. Even though there is strong scientific evidence for beneficial effects of health promoting interventions including physical exercise and self-management strategies, a very limited proportion of the people with COPD get access to such services in the primary care. There is an obvious need to find ways to implement available knowledge in clinical practice. Accordingly, KOL-webben is developed as a method (measure/tool) to implement evidence based health promotion interventions and to facilitate the delivery of such services to people with COPD. KOL-webben is also developed as a tool that will support self-management including health promotion among people with COPD. The design of the explorative feasibility study will be an controlled study with a baseline assessment, delivery of the intervention during 3 months and a follow-up at two month after the completion of the delivery. In order to explore best practice, the usefulness and the effect of the intervention, the feasibility of the data collection and recruitment of people with COPD, a process evaluation will be carried out.Two primary health care units in the county council of Västerbotten in northern Sweden and four primary units in the county council of Dalarna in Mid Sweden will be included in the study. The units will represent both rural and urban settings. KOL-webben is an interactive web-based system directed towards two target groups; people with COPD and health care professionals. The section directed towards people with COPD will provide tools that improve health literacy and thereby promote and enable a healthier lifestyle with a specific focus on 1) increased physical activity and 2) use appropriate self-management strategies. The tools include educational material, use of (e.g. texts, images, movies, web-links) and interactive components (e.g. ability to report steps per day and symptoms with feedback) adapted to the different stages of the disease. The section directed towards health care professionals includes tools that aim to improve the knowledge, attitudes and confidence in providing evidence based health promotion interventions. The tools include easily accessible knowledge and material (e.g. movies, screening tests, images, power point presentation for patient education and exercise programs).The control group will be recruited from the same health care units among listed patients with no planned visit within the 3 month intervention period. The control group will not receive any intervention. All persons with COPD who visits the primary care centre during the study period will constitute the sample in the intervention group (KOL-webben). The control group will be recruited from the same primary health care units among listed patients with no planned visit within the 3 month intervention period A subgroup of 40 persons (8 from each unit) will be included in additional assessment according to the following: measure of physical activity, measure of physical activity and the process evaluation, or the process evaluation alone. The subgroup will be consecutively recruited among those who visit the primary care centres. Measures of physical activity will also be made in a similar size subgroup of participants in the control group. Before and after the three month intervention period effects on impact of COPD in daily life, health literacy, confidence in managing their COPD, aspects of physical activity, self-efficacy to perform physical activity, quality of life, dyspnea and level of physical activity will be collected. In addition will we determine effects on instrumental and conceptual knowledge among health professionals

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Disease, Chronic Obstructive, Feasibility, Health promotion tool, Self management, Evidence based care, Knowledge transfer, Implementation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KOLwebben
Arm Type
Experimental
Arm Description
Patients in the experimental group will be introduced to KOL-webben during their ordinary visits to the primary care center. All patients will receive a pedometer
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Other than receiving a pedometer the patients in the control group will not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
KOLwebben
Intervention Description
KOL-webben will be introduced to all people with COPD during their ordinary visits to the primary care center during a 3 months period. The introduction to KOL-webben will be tailored to each person's needs and include 1) registration of the patient at KOL-webben 2) showing and discussing specific content on KOL-webben (e.g. movies with exercises if the person needs exercise training) chosen to meet the needs of the individual 3) giving a card (A5 format) with address to KOL-webben, user information and references to chosen content on KOL-webben. All patients will also receive a pedometer.
Primary Outcome Measure Information:
Title
Change in impact of COPD in daily life
Description
Impact of COPD in daily life will be assessed using the COPD assessment test.
Time Frame
Baseline and 3 months after baseline
Secondary Outcome Measure Information:
Title
Change in health literacy
Description
Health literacy will be assessed using the Swedish C & C HL Scale.
Time Frame
Baseline and 3 months after baseline
Title
Change in confidence in managing their COPD
Description
Confidence in managing their COPD will be assessed using questions specifically developed for this study (face validity will be tested)
Time Frame
Baseline and 3 months after baseline
Title
Change in aspects of physical activity
Description
Aspects of physical activity will be assessed using the Grimby's Activity Scale
Time Frame
Baseline and 3 months after baseline
Title
Change in aspects of physical activity
Description
Aspects of physical activity will be assessed using indicators about physical activity retrieved from the National Board of Health and Welfare
Time Frame
Baseline and 3 months after baseline
Title
Change in self-efficacy to perform physical activity
Description
Self-efficacy to perform physical activity will be assessed using The SCI Exercise Self-Efficacy Scale (ESES).
Time Frame
Baseline and 3 months after baseline
Title
Change in quality of life
Description
Quality of life will be assessed using the EQ5D.
Time Frame
Baseline and 3 months after baseline
Title
Change in dyspnea severity
Description
Dyspnea severity will be assessed using the Medical Research Council Scale.
Time Frame
Baseline and 3 months after baseline
Title
Change in level of physical activity
Description
Level of physical activity will be measured with an activity monitor, the DynaPort MiniMod. The activity monitor data collected during 7 Days at baseline and 7 Days 3 months after baseline will be used to assess change in level of physical activity.
Time Frame
7 Days at baseline and and 7 days at 3 months after baseline
Title
Change in instrumental knowledge among health professionals
Description
Instrumental knowledge use of evidence based health promotion interventions will be assessed through a review of medical records; a baseline review of medical record of patients with a COPD diagnosis who have visited the primary care centre during August and September 2015 will be performed and a follow-up review will be performed after the end of the study period.
Time Frame
Baseline and 3 months after baseline
Title
Change in conceptual knowledge among health professionals
Description
Conceptual knowledge use (i.e. knowledge, attitudes, and intentions) will be assessed using a questionnaire including both structured and semi-structured questions at baseline and at follow-up
Time Frame
Baseline and 3 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults 40 years and above diagnosed with COPD according to GOLD criteria i.e. Forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) < 0.70. Needs to understand Swedish or have access to anyone who understands Swedish. Exclusion Criteria: Not COPD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Wadell, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre Nyberg, PhD
Organizational Affiliation
Umeå University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Malin Tistad, PhD
Organizational Affiliation
Umeå University
Official's Role
Study Director
Facility Information:
Facility Name
Umeå university
City
Umeå
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33929327
Citation
Marklund S, Tistad M, Lundell S, Ostrand L, Sorlin A, Bostrom C, Wadell K, Nyberg A. Experiences and Factors Affecting Usage of an eHealth Tool for Self-Management Among People With Chronic Obstructive Pulmonary Disease: Qualitative Study. J Med Internet Res. 2021 Apr 30;23(4):e25672. doi: 10.2196/25672.
Results Reference
derived
PubMed Identifier
28765136
Citation
Nyberg A, Wadell K, Lindgren H, Tistad M. Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare. BMJ Open. 2017 Aug 1;7(7):e016851. doi: 10.1136/bmjopen-2017-016851.
Results Reference
derived

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Feasibility and Effects of KOL-webben in Patients With COPD

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