Servicio de Evaluación de. Servicio Canario de Salud -
Santa Cruz de Tenerife, 38004, Spain
NCT Number: NCT03254771
The main goal of this study is assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Santa Cruz de Tenerife, 38004, Spain
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 disease/treatments, informed choice and the satisfaction with the decision making process, and decreasing decisional regret.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
Time frame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
The DCS measures patients' uncertainty about treatment choice. It is composed of five subscales: uninformed, values, support, uncertainty and effectiveness
Time frame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
A 7-item scale will be udes to assess patients' knowledge of the disease and treatments
Time frame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
A 10-item scale will assess the importance that patients attribute to different characteristics of avaliable treatments
Time frame: Immediately after the intervention; 6 months (only non-operated patients)
Patients will be asked the treatment they prefer: AINEs, knee injections or arthroplasty
Time frame: Immediately after the intervention; 6 months
The scale developed by Barry et al. (1997) will be used, composed of 12 items measuring patients' satisfaction with information and care provided
Time frame: 6 months (only operated patients)
The DRS contains five items measuring patients regret with the treatment decision
Servicio Canario de Salud
Other
Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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