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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02974036
Other study ID # 782-14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date December 2019

Study information

Verified date February 2022
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date December 2019
Est. primary completion date October 18, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Patient education for osteoarthritis
Group sessions and optional supervised exercise.

Locations

Country Name City State
Sweden Primary Health Care Malmo

Sponsors (1)

Lead Sponsor Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Swedish Rheumatic Empowerment Scale Questionnaire Before intervention, directly after intervention and at 3 and 9 month follow up
Other EQ5D index Questionnaire Before intervention, directly after intervention and at 3 and 9 month follow up
Other Health care consumption Linked register data from the Skåne Health Care Register 12 months before baseline and 12 months after baseline
Other Sick leave Linked register data from the Swedish Social Insurance Agency 12 months before baseline and 12 months after baseline
Other EQ5D Health barometer visual analogue scale Before intervention, directly after intervention and at 3 and 9 month follow up
Primary Patient enablement Questionnaire directly after intervention
Secondary Arthritis Self Efficacy Scale Questionnaire before intervention, directly after intervention and at 3 and 9 month follow up
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