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Completed

NCT Number: NCT03254771

Effectiveness of a Decision Aid for Knee Osteoarthritis

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Evaluación de. Servicio Canario de Salud -

Santa Cruz de Tenerife, 38004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with osteoarthritis of the knee
  • Candidates for arthroplasty

Exclusion criteria

  • Patients who have already undergone knee arthroplasty
  • Patients younger than 18 years

Treatment and study plan

Decision Aid

Other

Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health

Primary outcomes

  1. Decisional conflict, measured by the Decisional Conflict Scale (DCS).

    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

Secondary outcomes

  1. Knowledge of the disease and treatments

    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

  2. Goals and concerns

    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

  3. Treatment preference

    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

  4. Satisfaction with the decision making process

    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

  5. Decisional regret, measured by the Decisional Regret Scale (DRS)

    Time frame: 6 months (only operated patients)

    The DRS contains five items measuring patients regret with the treatment decision

Sponsors and collaborators

Lead sponsor

Servicio Canario de Salud

Other

Collaborators

  • Hospital Donostia
  • Hospital de Basurto

Registry information

Official study title

Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 18, 2017
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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