Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03254771
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2017-06-05
Brief Title:
Effectiveness of a Decision Aid for Knee Osteoarthritis
Sponsor:
Servicio Canario de Salud
Organization:
Servicio Canario de Salud
Study Overview
Official Title:
Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main goal of this study is assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART
Detailed Description:
The number of knee total arthroplasty ART interventions has increased in the last 10 years in European countries partly due to the aging of the population and partly because of the increase in the use of these interventions to improve the quality of life among elderly patients According to the Organization for Economic Cooperation and Development OECD 2012 from 2000 to 2010 in Spain the percentage of knee ART has doubled in recent years
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 diseasetreatments informed choice and the satisfaction with the decision making process and decreasing decisional regret
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 diseasetreatments informed choice and the satisfaction with the decision making process and decreasing decisional regret
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None