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

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

Tracking Information

• First Submitted Date: August 17, 2016
• First Posted Date: November 28, 2016
• Last Update Posted Date: January 16, 2019
• Actual Study Start Date: August 2016
• Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 22, 2016)

Patient enablement [ Time Frame: directly after intervention ]

Questionnaire

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02974036 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: 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: Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Patient Education as Topic
• Osteoarthritis

Intervention

Other: Patient education for osteoarthritis

Group sessions and optional supervised exercise.

Study Arms

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 22, 2016): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

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: Sweden

Administrative Information

• NCT Number: NCT02974036
• Other Study ID Numbers: 782-14
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Eva Ekvall-Hansson, Lund University
• Study Sponsor: Lund University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Lund University
• Verification Date: January 2019