NCT02974036

Brief Summary

The overall purpose is to study quality in patient education by means of the patients' self-rated enablement. Specific aims are: To assess the validity of the patient enablement instrument in relation to self-efficacy and empowerment; To investigate if patient enablement can be effective in identifying which patients would benefit the most from patient education; To study if patient enablement has any relation to self-efficacy, function or self-rated health; To analyze if patient enablement has a causal effect on health care consumption; To evaluate whether patient education is a cost-effective intervention. The project is a longitudinal study, including patients from a patient education programme for osteoarthritis in primary health care. Data consist of patient reported outcome measures and health care consumption. Cost-effectiveness and cost-utility analysis will be used. Inclusion of patients will start August 2016. Analyses of data and manuscript writing will be performed in 2018-2019. Researchers included are from primary health care settings and researchers in the field of OA, patient education and health economy. Our increasingly older and more inactive population will raise huge demands on the health care. The importance of optimizing treatments that are available in primary health care cannot be underestimated. The project will contribute with important knowledge about the patient's own process of getting well.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

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

Study Start

First participant enrolled

August 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

August 17, 2016

Last Update Submit

February 25, 2022

Conditions

Keywords

Patient educationOsteoarthritisPrimary health care

Outcome Measures

Primary Outcomes (1)

  • Patient enablement

    Questionnaire

    directly after intervention

Secondary Outcomes (1)

  • Arthritis Self Efficacy Scale

    before intervention, directly after intervention and at 3 and 9 month follow up

Other Outcomes (5)

  • Swedish Rheumatic Empowerment Scale

    Before intervention, directly after intervention and at 3 and 9 month follow up

  • EQ5D index

    Before intervention, directly after intervention and at 3 and 9 month follow up

  • Health care consumption

    12 months before baseline and 12 months after baseline

  • +2 more other outcomes

Study Arms (1)

Patient education for osteoarthritis

The intervention in the education program consists of three group lessons of about 90 minutes each where information about ethiology, risk factors, treatment and coping strategies concerning OA is included. The first two lessons are held by a physiotherapist and the third by a so-called expert patient that is a person with OA who shares his or her experiences of how to live with the disease. After the intervention patients are able to choose if they want to exercise at home or in a group, supervised by a physiotherapist.

Other: Patient education for osteoarthritis

Interventions

Group sessions and optional supervised exercise.

Patient education for osteoarthritis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are referred to patient education for OA in primary health care
  • Speaks and write Swedish

You may not qualify if:

  • Not having OA
  • Not able to speak or write Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Health Care

Malmo, SE20502, Sweden

Location

Related Publications (3)

  • Hansson EE, Jonsson-Lundgren M, Ronnheden AM, Sorensson E, Bjarnung A, Dahlberg LE. Effect of an education programme for patients with osteoarthritis in primary care--a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:244. doi: 10.1186/1471-2474-11-244.

    PMID: 20969809BACKGROUND
  • Akesson KS, Sunden A, Stigmar K, Eek F, Pawlikowska T, Hansson EE. Empowerment and enablement and their associations with change in health-related quality of life after a supported osteoarthritis self-management programme - a prospective observational study. Arch Physiother. 2023 Sep 22;13(1):18. doi: 10.1186/s40945-023-00172-7.

  • Akesson KS, Sunden A, Stigmar K, Fagerstrom C, Pawlikowska T, Ekvall Hansson E. Enablement and empowerment among patients participating in a supported osteoarthritis self-management programme - a prospective observational study. BMC Musculoskelet Disord. 2022 Jun 8;23(1):555. doi: 10.1186/s12891-022-05457-9.

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eva Ekvall Hansson, Ass prof

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer, associate professor

Study Record Dates

First Submitted

August 17, 2016

First Posted

November 28, 2016

Study Start

August 1, 2016

Primary Completion

October 18, 2019

Study Completion

December 1, 2019

Last Updated

March 14, 2022

Record last verified: 2022-02

Locations