NCT02696187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

January 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
Last Updated

August 5, 2019

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

January 14, 2016

Last Update Submit

August 1, 2019

Conditions

Keywords

Pulmonary Disease, Chronic ObstructiveFeasibilityHealth promotion toolSelf managementEvidence based careKnowledge transferImplementation

Outcome Measures

Primary Outcomes (1)

  • Change in impact of COPD in daily life

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

    Baseline and 3 months after baseline

Secondary Outcomes (10)

  • Change in health literacy

    Baseline and 3 months after baseline

  • Change in confidence in managing their COPD

    Baseline and 3 months after baseline

  • Change in aspects of physical activity

    Baseline and 3 months after baseline

  • Change in aspects of physical activity

    Baseline and 3 months after baseline

  • Change in self-efficacy to perform physical activity

    Baseline and 3 months after baseline

  • +5 more secondary outcomes

Study Arms (2)

KOLwebben

EXPERIMENTAL

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

Behavioral: KOLwebben

Control group

NO INTERVENTION

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

Interventions

KOLwebbenBEHAVIORAL

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.

KOLwebben

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå university

Umeå, Sweden

Location

Related Publications (3)

  • Nyberg A, Sondell A, Lundell S, Marklund S, Tistad M, Wadell K. Experiences of Using an Electronic Health Tool Among Health Care Professionals Involved in Chronic Obstructive Pulmonary Disease Management: Qualitative Analysis. JMIR Hum Factors. 2023 Mar 30;10:e43269. doi: 10.2196/43269.

  • 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.

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karin Wadell, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR
  • Andre Nyberg, PhD

    Umeå University

    STUDY DIRECTOR
  • Malin Tistad, PhD

    Umeå University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 14, 2016

First Posted

March 2, 2016

Study Start

January 21, 2016

Primary Completion

May 15, 2017

Study Completion

March 15, 2018

Last Updated

August 5, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations