A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty

NCT ID: NCT03240913

Last Updated: 2020-04-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2020-03-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objectives of this study are to: 1) develop an educational tool known as the Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine what to expect if they choose either option; 2) assess the extent that the PROM-DA improves patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA in multiple sites and more patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis Total Knee Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

Group Type EXPERIMENTAL

Baseline and Follow-up Surveys

Intervention Type BEHAVIORAL

(completed online)

Patient Reported Outcome Measure informed Decision Aid

Intervention Type OTHER

(PROM-DA)

Non Treatment Group

Conventional information

Group Type PLACEBO_COMPARATOR

Baseline and Follow-up Surveys

Intervention Type BEHAVIORAL

(completed online)

Pamphlet

Intervention Type OTHER

(usual care)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Baseline and Follow-up Surveys

(completed online)

Intervention Type BEHAVIORAL

Patient Reported Outcome Measure informed Decision Aid

(PROM-DA)

Intervention Type OTHER

Pamphlet

(usual care)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult (age≄30) patients with knee osteoarthritis (OA)
* Have an appointment with a surgeon for consultation about Total Knee Arthroplasty at the Edmonton Bone and Joint Centre
* Understands, speaks and reads English; and
* Able to provide informed consent.

Exclusion Criteria

* Individuals who have had prior total knee arthroplasty
* Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Fibromyalgia, or Gout.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of British Columbia

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Edmonton Bone and Joint Centre

Edmonton, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Bansback N, Trenaman L, MacDonald KV, Hawker G, Johnson JA, Stacey D, Marshall DA. An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2019 Feb 23;20(1):89. doi: 10.1186/s12891-019-2434-2.

Reference Type DERIVED
PMID: 30797238 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REB16-0869

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Computer Assisted Total Knee Replacement
NCT00279838 COMPLETED PHASE4