Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care

February 25, 2022 updated by: Eva Ekvall-Hansson, Lund University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The project is a longitudinal study, including patients who are referred to patient education for osteoarthritis in primary health care and is planned to follow the patients one year before baseline measures as well as one year after baseline measures.

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmo, Sweden, SE20502
        • Primary Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Group sessions and optional supervised exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient enablement
Time Frame: directly after intervention
Questionnaire
directly after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arthritis Self Efficacy Scale
Time Frame: before intervention, directly after intervention and at 3 and 9 month follow up
Questionnaire
before intervention, directly after intervention and at 3 and 9 month follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swedish Rheumatic Empowerment Scale
Time Frame: Before intervention, directly after intervention and at 3 and 9 month follow up
Questionnaire
Before intervention, directly after intervention and at 3 and 9 month follow up
EQ5D index
Time Frame: Before intervention, directly after intervention and at 3 and 9 month follow up
Questionnaire
Before intervention, directly after intervention and at 3 and 9 month follow up
Health care consumption
Time Frame: 12 months before baseline and 12 months after baseline
Linked register data from the Skåne Health Care Register
12 months before baseline and 12 months after baseline
Sick leave
Time Frame: 12 months before baseline and 12 months after baseline
Linked register data from the Swedish Social Insurance Agency
12 months before baseline and 12 months after baseline
EQ5D Health barometer
Time Frame: Before intervention, directly after intervention and at 3 and 9 month follow up
visual analogue scale
Before intervention, directly after intervention and at 3 and 9 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Principal Investigator: Eva Ekvall Hansson, Ass prof, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

October 18, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

February 25, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 782-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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