Effectiveness of a Decision Aid for Knee Osteoarthritis
NCT ID: NCT03254771
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
193 participants
INTERVENTIONAL
2017-08-16
2018-12-31
Brief Summary
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Detailed Description
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The role of citizens in decisions affecting their health is changing. Individual factors such as improving educational attainment and access to medical information, and collective factors such as training of patient groups and changes in legislation (informed consent, autonomy principle) have motivated the transition from a paternalistic model to a co-responsibility model. Shared decision-making (TDC) has been proposed in recent years as a model of care that promotes users' involvement in the decisions about their treatment, in those situations where there is uncertainty and / or the scientific evidence reports a balance between benefits and risks that is similar for two or more therapeutic options. Decision aids (DA) are tools designed to promote and facilitate patients' involvement in medical decisions concerning their health
Objectives:
To assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART
Methodology:
Randomized controlled trial to evaluate the effectiveness of the DA versus usual care in reducing decisional conflict, increasing knowledge of the disease/treatments, informed choice and the satisfaction with the decision making process, and decreasing decisional regret.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control group
In the control group, the usual explanation about the disease and the possibilities of treatment will be followed
No interventions assigned to this group
Intervention group
In the Intervention group, the Decision Aid (DA) will be presented and explained to the patient by research personnel at a schedule previously agreed with the patient. The patient will be given a paper copy of the (DA) to take home, as well as a web link to the computer application, and oral and written instructions to review the material again and perform value clarification exercises.
Decision aid
Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
Interventions
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Decision aid
Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
Eligibility Criteria
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Inclusion Criteria
* Candidates for arthroplasty
Exclusion Criteria
* Patients younger than 18 years
18 Years
90 Years
ALL
No
Sponsors
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Hospital de Basurto
OTHER
Hospital Donostia
OTHER
Servicio Canario de Salud
OTHER
Responsible Party
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Principal Investigators
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Amado Rivero Santana, PhD
Role: STUDY_CHAIR
Researcher
Locations
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Servicio de Evaluación de. Servicio Canario de Salud -
Santa Cruz de Tenerife, , Spain
Countries
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Other Identifiers
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PI15-01264
Identifier Type: -
Identifier Source: org_study_id
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