Effectiveness of a Decision Aid for Knee Osteoarthritis

NCT ID: NCT03254771

Last Updated: 2020-01-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2018-12-31

Brief Summary

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The main goal of this study is assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART

Detailed Description

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Open label

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

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

Decision aid

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Basurto

OTHER

Sponsor Role collaborator

Hospital Donostia

OTHER

Sponsor Role collaborator

Servicio Canario de Salud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Spain

Other Identifiers

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PI15-01264

Identifier Type: -

Identifier Source: org_study_id

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