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Trial record 7 of 561 for:    Recruiting, Not yet recruiting, Available Studies | Teaching

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

Tracking Information
First Submitted Date  ICMJE August 17, 2016
First Posted Date  ICMJE November 28, 2016
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE August 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
Patient enablement [ Time Frame: directly after intervention ]
Questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02974036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
Arthritis Self Efficacy Scale [ Time Frame: before intervention, directly after intervention and at 3 and 9 month follow up ]
Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 22, 2016)
  • Swedish Rheumatic Empowerment Scale [ Time Frame: Before intervention, directly after intervention and at 3 and 9 month follow up ]
    Questionnaire
  • EQ5D index [ Time Frame: Before intervention, directly after intervention and at 3 and 9 month follow up ]
    Questionnaire
  • Health care consumption [ Time Frame: 12 months before baseline and 12 months after baseline ]
    Linked register data from the Skåne Health Care Register
  • Sick leave [ Time Frame: 12 months before baseline and 12 months after baseline ]
    Linked register data from the Swedish Social Insurance Agency
  • EQ5D Health barometer [ Time Frame: Before intervention, directly after intervention and at 3 and 9 month follow up ]
    visual analogue scale
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care
Official Title  ICMJE Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Patient Education as Topic
  • Osteoarthritis
Intervention  ICMJE Other: Patient education for osteoarthritis
Group sessions and optional supervised exercise.
Study Arms  ICMJE 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.
Intervention: Other: Patient education for osteoarthritis
Publications * Hansson EE, Jönsson-Lundgren M, Ronnheden AM, Sörensson E, Bjärnung 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 22, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eva Ekvall Hansson, Ass prof +4646-2221986 eva.ekvall-hansson@med.lu.se
Contact: Karin Åkesson, MSc karin.sturesdotter_akesson@med.lu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02974036
Other Study ID Numbers  ICMJE 782-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Eva Ekvall-Hansson, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eva Ekvall Hansson, Ass prof Lund University
PRS Account Lund University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP