Knee OsteoarthritisNCT03240913
A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty
A study testing Baseline and Follow-up Surveys, Patient Reported Outcome Measure informed Decision Aid and Pamphlet in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by University of Calgary at 1 site in Canada.
Trial 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)… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Baseline and Follow-up Surveys, Patient Reported Outcome Measure informed Decision Aid and Pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jun 2017to 3 Mar 2020
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals who have had prior total knee arthroplasty
- Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Fibromyalgia, or Gout.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.
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.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Baseline and Follow-up Surveys, Patient Reported Outcome Measure informed Decision Aid, Pamphlet
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline and Follow-up SurveysBehavioural
(completed online)
Patient Reported Outcome Measure informed Decision AidOther
(PROM-DA)
PamphletOther
(usual care)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Behavioral: Baseline and Follow-up Surveys; Other: Patient Reported Outcome Measure informed Decision Aid |
| Non Treatment Group | Placebo comparator | Conventional information Receives: Behavioral: Baseline and Follow-up Surveys; Other: Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision quality
Hip and Knee Decision Quality Instrument (HK-DQI)
Measured: 40 to 52 weeks after baseline
Secondary outcomes (16)
Quality of life (generic)
Euroqol Five Dimensions Questionnaire (EQ-5D-5L)
Measured: 40 to 52 weeks after baseline
Quality of life (condition-specific)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 40 to 52 weeks after baseline
Depression
The Patient Health Questionnaire (PHQ-9)
Measured: 40 to 52 weeks after baseline
Knowledge about total knee arthroplasty surgery
HK-DQI
Measured: Baseline
Values
HK-DQI
Measured: Baseline
Decisional conflict
Decisional Conflict Scale (SURE)
Measured: Baseline
Treatment Preference
Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks?
Yes No Unsure
Measured: Baseline
Preference for involvement in decision making
Control Preferences Scale (CPS)
Measured: Baseline
Willingness to have surgery
Single item question: Based on your current understanding of the risks and benefits of knee replacement surgery of your knee arthritis, what is your current preference between having joint replacement surgery or non-surgical treatments?
I would definitely consider having knee joint replacement surgery now. I would probably consider having knee joint replacement surgery now. I am not sure. I would probably not consider having knee joint replacement surgery now. I would definitely not consider having knee joint replacement surgery now.
Measured: Baseline
Patient-reported shared decision-making
CollaboRATE
Measured: 3 to 6 weeks after baseline
Decisional regret
Decision Regret Scale
Measured: 40 to 52 weeks after baseline
Satisfaction with knee replacement surgery
Three item questionnaire:
- Overall, how satisfied are you with the results of your knee replacement surgery?
- How satisfied are you with your knee replacement surgery for reducing your pain when walking on a flat surface? Going up or down stairs? Sitting or lying down?
- How satisfied are you with your most recent knee replacement surgery for improving your ability to perform five functions: Going up stairs? Getting in/out of a car or on/off a bus? Rising from bed? Lying in bed? Performing light domestic duties?
Responses from 'very dissatisfied' to ' very satisfied'
Measured: 40 to 52 weeks after baseline
Expectations
Single item question from Bourne et al. 2010. Clin Orthop Relat Res. related to whether expectations were met; not met; or whether they had no expectations.
Measured: 40 to 52 weeks after baseline
Surgical consult
Electronic Medical Records (EMR)
Measured: 1 to 4 weeks after baseline
Surgery
EMR
Measured: 27 to 30 weeks after baseline
Concordance
HK-DQI
Measured: 40 to 52 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start19 Jun 2017
- Primary completion18 Oct 2018
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240913
- Sponsor's protocol ID
- REB16-0869
- Status last verified
- Apr 2020
- First submitted
- 27 Jul 2017
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30797238
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03240913
- Acronym / sponsor ID
- REB16-0869
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 7 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Baseline and Follow-up Surveys, Other: Patient Reported Outcome Measure informed Decision Aid |
| Non Treatment Group | Placebo comparator | Behavioral: Baseline and Follow-up Surveys, Other: PamphletConventional information |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals who have had prior total knee arthroplasty
- Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Fibromyalgia, or Gout.
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 |
|---|---|---|
| Baseline and Follow-up Surveys(completed online) | Behavioural | Non Treatment Group, Treatment Group |
| Patient Reported Outcome Measure informed Decision Aid(PROM-DA) | Other | Treatment Group |
| Pamphlet(usual care) | Other | Non Treatment Group |
Primary outcome
Decision quality
Time frame: 40 to 52 weeks after baseline
Hip and Knee Decision Quality Instrument (HK-DQI)
16 secondary outcomes
Quality of life (generic)
Time frame: 40 to 52 weeks after baseline
Quality of life (condition-specific)
Time frame: 40 to 52 weeks after baseline
Depression
Time frame: 40 to 52 weeks after baseline
Knowledge about total knee arthroplasty surgery
Time frame: Baseline
Values
Time frame: Baseline
Decisional conflict
Time frame: Baseline
Treatment Preference
Time frame: Baseline
Preference for involvement in decision making
Time frame: Baseline
Willingness to have surgery
Time frame: Baseline
Patient-reported shared decision-making
Time frame: 3 to 6 weeks after baseline
Decisional regret
Time frame: 40 to 52 weeks after baseline
Satisfaction with knee replacement surgery
Time frame: 40 to 52 weeks after baseline
Expectations
Time frame: 40 to 52 weeks after baseline
Surgical consult
Time frame: 1 to 4 weeks after baseline
Surgery
Time frame: 27 to 30 weeks after baseline
Concordance
Time frame: 40 to 52 weeks after baseline
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 28 Apr 2020.
- Derived from this study: PubMed 30797238Bansback 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline and Follow-up Surveys, Patient Reported Outcome Measure informed Decision Aid and Pamphlet in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by University of Calgary at 1 site in Canada.
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 4 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 28 Apr 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Decision quality (time frame: 40 to 52 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03240913, which also lists 1 linked publication.
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 28 Apr 2020; AzTrials last refreshed its copy on 29 Oct 2026.