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

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ClinicalTrials.gov Identifier: NCT02974036
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eva Ekvall-Hansson, Lund University

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.


Condition or disease Intervention/treatment Phase
Patient Education as Topic Osteoarthritis Other: Patient education for osteoarthritis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care
Actual Study Start Date : August 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 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.




Primary Outcome Measures :
  1. Patient enablement [ Time Frame: directly after intervention ]
    Questionnaire


Secondary Outcome Measures :
  1. Arthritis Self Efficacy Scale [ Time Frame: before intervention, directly after intervention and at 3 and 9 month follow up ]
    Questionnaire


Other Outcome Measures:
  1. Swedish Rheumatic Empowerment Scale [ Time Frame: Before intervention, directly after intervention and at 3 and 9 month follow up ]
    Questionnaire

  2. EQ5D index [ Time Frame: Before intervention, directly after intervention and at 3 and 9 month follow up ]
    Questionnaire

  3. Health care consumption [ Time Frame: 12 months before baseline and 12 months after baseline ]
    Linked register data from the Skåne Health Care Register

  4. Sick leave [ Time Frame: 12 months before baseline and 12 months after baseline ]
    Linked register data from the Swedish Social Insurance Agency

  5. EQ5D Health barometer [ Time Frame: Before intervention, directly after intervention and at 3 and 9 month follow up ]
    visual analogue scale



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974036


Contacts
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Contact: Eva Ekvall Hansson, Ass prof +4646-2221986 eva.ekvall-hansson@med.lu.se
Contact: Karin Åkesson, MSc karin.sturesdotter_akesson@med.lu.se

Locations
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Sweden
Primary Health Care Recruiting
Malmo, Sweden, SE20502
Contact: Malin Lundgren, RPT    +46 766-48 62 64    malin.JonssonLundgren@skane.se   
Principal Investigator: Karin Åkesson, MSc         
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Eva Ekvall Hansson, Ass prof Lund University

Additional Information:
Publications:
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Responsible Party: Eva Ekvall-Hansson, Senior lecturer, associate professor, Lund University
ClinicalTrials.gov Identifier: NCT02974036     History of Changes
Other Study ID Numbers: 782-14
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Eva Ekvall-Hansson, Lund University:
Patient education
Osteoarthritis
Primary health care
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases