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

• Sponsor: Lund University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02974036
• Collaborator: (none)
• Enrollment: 143
• Location: 1
• Actual Duration (Months): 40
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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

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 Design

• Study Type: Observational
• Actual Enrollment: 143 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Oct 18, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. Patient enablement [directly after intervention]

   Questionnaire

Secondary Outcome Measures

1. Arthritis Self Efficacy Scale [before intervention, directly after intervention and at 3 and 9 month follow up]

   Questionnaire

Other Outcome Measures

1. Swedish Rheumatic Empowerment Scale [Before intervention, directly after intervention and at 3 and 9 month follow up]

   Questionnaire

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

   Questionnaire

3. Health care consumption [12 months before baseline and 12 months after baseline]

   Linked register data from the Skåne Health Care Register

4. Sick leave [12 months before baseline and 12 months after baseline]

   Linked register data from the Swedish Social Insurance Agency

5. EQ5D Health barometer [Before intervention, directly after intervention and at 3 and 9 month follow up]

   visual analogue scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary Health Care	Malmo		Sweden	SE20502

Sponsors and Collaborators

• Lund University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BOA registry

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.

• Responsible Party: Eva Ekvall-Hansson, Senior lecturer, associate professor, Lund University
• ClinicalTrials.gov Identifier: NCT02974036
• Other Study ID Numbers: 782-14
• First Posted: Nov 28, 2016
• Last Update Posted: Mar 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Eva Ekvall-Hansson, Senior lecturer, associate professor, Lund University: Patient education; Osteoarthritis; Primary health care
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Mar 14, 2022