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Trial record 2 of 252330 for:    ALL

Effectiveness of a Decision Aid for Knee Osteoarthritis

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Servicio Canario de Salud
Sponsor:
Collaborators:
Hospital de Basurto
Hospital Donostia
Information provided by (Responsible Party):
Servicio Canario de Salud
ClinicalTrials.gov Identifier:
NCT03254771
First received: June 5, 2017
Last updated: August 16, 2017
Last verified: April 2017
  Purpose
The main goal of this study is assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART

Condition Intervention
Osteoarthritis, Knee Other: Decision aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open label
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty

Resource links provided by NLM:


Further study details as provided by Servicio Canario de Salud:

Primary Outcome Measures:
  • Decisional conflict, measured by the Decisional Conflict Scale (DCS). [ Time Frame: Immediately after the intervention ]
    The DCS measures patients' uncertainty about treatment choice. It is composed of five subscales: uninformed, values, support, uncertainty and effectiveness


Secondary Outcome Measures:
  • Knowledge of the disease and treatments [ Time Frame: Immediately after the intervention ]
    A 7-item scale will be udes to assess patients' knowledge of the disease and treatments

  • Goals and concerns [ Time Frame: Immediately after the intervention ]
    A 10-item scale will assess the importance that patients attribute to different characteristics of avaliable treatments

  • Treatment preference [ Time Frame: Immediately after the intervention ]
    Patients will be asked the treatment they prefer: AINEs, knee injections or arthroplasty

  • Satisfaction with the decision making process [ Time Frame: 3 months ]
    The scale developed by Barry et al. (1997) will be used, composed of 12 items measuring patients' satisfaction with information and care provided

  • Decisional regret, measured by the Decisional Regret Scale (DRS) [ Time Frame: 3 months ]
    The DRS contains five items measuring patients regret with the treatment decision


Estimated Enrollment: 226
Anticipated Study Start Date: August 16, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
In the control group, the usual explanation about the disease and the possibilities of treatment will be followed
Experimental: 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.
Other: Decision aid
Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health

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:

Cluster 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03254771

Contacts
Contact: Pedro Serrano Aguilar, MD, PhD 34922475714 pseragu@gobiernodecanarias.org
Contact: Lilisbeth Perestelo Perez, PhD 922 684019 lilisbeth.peresteloperez@sescs.es

Locations
Spain
Servicio de Evaluación de. Servicio Canario de Salud - Recruiting
Santa Cruz de Tenerife, Spain, 38004
Contact: Alezandra Torres Castaño, PhD    922680023    atorrcas@sescs.es   
Sponsors and Collaborators
Servicio Canario de Salud
Hospital de Basurto
Hospital Donostia
Investigators
Study Chair: Amado Rivero Santana, PhD Researcher
  More Information

Responsible Party: Servicio Canario de Salud
ClinicalTrials.gov Identifier: NCT03254771     History of Changes
Other Study ID Numbers: PI15-01264
Study First Received: June 5, 2017
Last Updated: August 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Servicio Canario de Salud:
Knee ostheoartritis
Arthroplasty
Clinical trial
Decision aids

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 18, 2017