NCT03254771

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

June 5, 2017

Last Update Submit

January 20, 2020

Conditions

Osteoarthritis, Knee

Keywords

Knee ostheoartritisArthroplastyClinical trialDecision aids

Outcome Measures

Primary Outcomes (1)

  • 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

    Immediately after the intervention; 6 months after the intervention (only non-operated patients)

Secondary Outcomes (5)

  • Knowledge of the disease and treatments

    Immediately after the intervention; 6 months after the intervention (only non-operated patients)

  • Goals and concerns

    Immediately after the intervention; 6 months after the intervention (only non-operated patients)

  • Treatment preference

    Immediately after the intervention; 6 months (only non-operated patients)

  • Satisfaction with the decision making process

    Immediately after the intervention; 6 months

  • Decisional regret, measured by the Decisional Regret Scale (DRS)

    6 months (only operated patients)

Study Arms (2)

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.

Other: Decision aid

Interventions

Decision aidOTHER

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

Intervention group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with osteoarthritis of the knee
  • Candidates for arthroplasty

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Evaluación de. Servicio Canario de Salud -

Santa Cruz de Tenerife, 38004, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Amado Rivero Santana, PhD

    Researcher

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open label
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2017

First Posted

August 18, 2017

Study Start

August 16, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)