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Effectiveness of a Decision Aid for Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Decision aid
Sponsored by
Servicio Canario de Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis, Knee focused on measuring Knee ostheoartritis, Arthroplasty, Clinical trial, Decision aids

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Servicio de Evaluación de. Servicio Canario de Salud -

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

In the control group, the usual explanation about the disease and the possibilities of treatment will be followed

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.

Outcomes

Primary Outcome Measures

Decisional conflict, measured by the Decisional Conflict Scale (DCS).
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
A 7-item scale will be udes to assess patients' knowledge of the disease and treatments
Goals and concerns
A 10-item scale will assess the importance that patients attribute to different characteristics of avaliable treatments
Treatment preference
Patients will be asked the treatment they prefer: AINEs, knee injections or arthroplasty
Satisfaction with the decision making process
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)
The DRS contains five items measuring patients regret with the treatment decision

Full Information

First Posted
June 5, 2017
Last Updated
January 20, 2020
Sponsor
Servicio Canario de Salud
Collaborators
Hospital de Basurto, Hospital Donostia
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1. Study Identification

Unique Protocol Identification Number
NCT03254771
Brief Title
Effectiveness of a Decision Aid for Knee Osteoarthritis
Official Title
Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Servicio Canario de Salud
Collaborators
Hospital de Basurto, Hospital Donostia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 disease/treatments, informed choice and the satisfaction with the decision making process, and decreasing decisional regret.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Knee ostheoartritis, Arthroplasty, Clinical trial, Decision aids

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
In the control group, the usual explanation about the disease and the possibilities of treatment will be followed
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Decision aid
Intervention Description
Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
Primary Outcome Measure Information:
Title
Decisional conflict, measured by the Decisional Conflict Scale (DCS).
Description
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)
Secondary Outcome Measure Information:
Title
Knowledge of the disease and treatments
Description
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)
Title
Goals and concerns
Description
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 after the intervention (only non-operated patients)
Title
Treatment preference
Description
Patients will be asked the treatment they prefer: AINEs, knee injections or arthroplasty
Time Frame
Immediately after the intervention; 6 months (only non-operated patients)
Title
Satisfaction with the decision making process
Description
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
Immediately after the intervention; 6 months
Title
Decisional regret, measured by the Decisional Regret Scale (DRS)
Description
The DRS contains five items measuring patients regret with the treatment decision
Time Frame
6 months (only operated patients)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amado Rivero Santana, PhD
Organizational Affiliation
Researcher
Official's Role
Study Chair
Facility Information:
Facility Name
Servicio de Evaluación de. Servicio Canario de Salud -
City
Santa Cruz de Tenerife
ZIP/Postal Code
38004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of a Decision Aid for Knee Osteoarthritis

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