Osteoarthritis, KneeNCT03254771
Effectiveness of a Decision Aid for Knee Osteoarthritis
A study testing Decision aid in people with Osteoarthritis, Knee, run by Servicio Canario de Salud at 1 site in Spain.
Trial summary
The main goal of this study is assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Decision aid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteSpain
- Study dates
- 16 Aug 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis of the knee
- Candidates for arthroplasty
Who cannot join
- Patients who have already undergone knee arthroplasty
- Patients younger than 18 years
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Evaluación de. Servicio Canario de Salud -
Santa Cruz de Tenerife, 38004
About this study
Official title: Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty
The main goal of this study is assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Decision aid
- Keywords
- Knee ostheoartritis, Arthroplasty, Clinical trial, Decision aids
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidOther
Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | In the control group, the usual explanation about the disease and the possibilities of treatment will be followed |
| Intervention group | Experimental | 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. Receives: Other: Decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
Secondary outcomes (5)
Knowledge of the disease and treatments
A 7-item scale will be udes to assess patients' knowledge of the disease and treatments
Measured: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
Goals and concerns
A 10-item scale will assess the importance that patients attribute to different characteristics of avaliable treatments
Measured: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
Treatment preference
Patients will be asked the treatment they prefer: AINEs, knee injections or arthroplasty
Measured: Immediately after the intervention; 6 months (only non-operated patients)
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
Measured: Immediately after the intervention; 6 months
Decisional regret, measured by the Decisional Regret Scale (DRS)
The DRS contains five items measuring patients regret with the treatment decision
Measured: 6 months (only operated patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start16 Aug 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servicio Canario de Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Basurto, Hospital Donostia
- Responsible party
- Sponsor
- Investigators
- Amado Rivero Santana, PhD, Study chair, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254771
- Sponsor's protocol ID
- PI15-01264
- Status last verified
- Jan 2020
- First submitted
- 5 Jun 2017
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty
- ClinicalTrials.gov ID
- NCT03254771
- Acronym / sponsor ID
- PI15-01264
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee ostheoartritis, Arthroplasty, Clinical trial, Decision aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Servicio Canario de SaludUniversity, hospital or other
- Collaborators
- Hospital de Basurto, Hospital Donostia
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –In the control group, the usual explanation about the disease and the possibilities of treatment will be followed |
| Intervention group | Experimental | Other: Decision aidIn 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with osteoarthritis of the knee
- Candidates for arthroplasty
Key exclusion criteria (2 listed)
- Patients who have already undergone knee arthroplasty
- Patients younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidDecision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health | Other | Intervention group |
Primary outcome
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
5 secondary outcomes
Knowledge of the disease and treatments
Time frame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
Goals and concerns
Time frame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
Treatment preference
Time frame: Immediately after the intervention; 6 months (only non-operated patients)
Satisfaction with the decision making process
Time frame: Immediately after the intervention; 6 months
Decisional regret, measured by the Decisional Regret Scale (DRS)
Time frame: 6 months (only operated patients)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amado Rivero Santana, PhD study chair
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Osteoarthritis, Knee, run by Servicio Canario de Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict, measured by the Decisional Conflict Scale (DCS). (time frame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.