A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty
1 other identifier
interventional
163
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jun 2017
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2017
CompletedFirst Submitted
Initial submission to the registry
July 27, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2020
CompletedApril 28, 2020
April 1, 2020
1.3 years
July 27, 2017
April 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Decision quality
Hip and Knee Decision Quality Instrument (HK-DQI)
40 to 52 weeks after baseline
Secondary Outcomes (16)
Quality of life (generic)
40 to 52 weeks after baseline
Quality of life (condition-specific)
40 to 52 weeks after baseline
Depression
40 to 52 weeks after baseline
Knowledge about total knee arthroplasty surgery
Baseline
Values
Baseline
- +11 more secondary outcomes
Study Arms (2)
Treatment Group
EXPERIMENTALNon Treatment Group
PLACEBO COMPARATORConventional information
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Individuals who have had prior total knee arthroplasty
- Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Fibromyalgia, or Gout.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- University of British Columbiacollaborator
Study Sites (1)
Edmonton Bone and Joint Centre
Edmonton, Alberta, T5E 5R8, Canada
Related Publications (1)
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.
PMID: 30797238DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2017
First Posted
August 7, 2017
Study Start
June 19, 2017
Primary Completion
October 18, 2018
Study Completion
March 3, 2020
Last Updated
April 28, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share