Knee OsteoarthritisNCT02416505
The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
A study testing Verbal+Anatomic Model and Verbal+Video in people with Knee Osteoarthritis, run by University of Missouri, Kansas City.
Trial summary
This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial. In this study, the investigators aim to evaluate the impact of a visual aid on patient comprehension an orthopedic informed consent discussion in low socioeconomic populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Verbal+Anatomic Model and Verbal+Video
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients newly diagnosed with Knee Osteoarthritis managed with steroid injections
- Patients who express lack of knowledge regarding knee osteoarthritis (causes, diagnosis, treatment, anatomy)
- English speaking
- Patients that meet the Federal Poverty Guideline for Healthcare (i.e. Medicaid)
Who cannot join
- Patients under the age of 18
- College graduates
- Non-English speaking
- Patient without the capacity to give consent
- Patients with a tactile, mental, visual or auditory disability
About this study
This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial.
In this study, the investigators aim to evaluate the impact of a visual aid on patient comprehension an orthopedic informed consent discussion in low socioeconomic populations.
The primary outcome is patient comprehension measured by a Validated Knowledge-Based Multiple Choice Questionnaire.
The secondary outcomes include: Patient satisfaction and Time efficiency.
The investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic informed consent discussion will improve patient comprehension, satisfaction and time-efficiency of orthopedic care.
- Conditions
- Knee Osteoarthritis
- Being tested
- Verbal+Anatomic Model, Verbal+Video
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal+Anatomic ModelBehavioural
Verbal+VideoBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Verbal Discussion: Control Group | No intervention | In this group, participants will receive a 10 minute Verbal Only Knee Osteoarthritis Steroid Injection Informed Consent discussion. This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection. |
| Verbal+Anatomic Model | Active comparator | This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Knee Model.
This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection. Receives: Behavioral: Verbal+Anatomic Model |
| Verbal+Video Presentation | Active comparator | This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Video.
This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection. Receives: Behavioral: Verbal+Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Nkem Test
Comprehension based examination of an informed consent discussion
Measured: 20 minutes
Secondary outcomes (1)
Patient Satisfaction Survey
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nkemakolam Egekeze, University of Missouri, Kansas City
- Investigators
- Mark Bernhardt, MD, Study chair, UMKC Department of Orthopaedic SurgeryJohnathan Dubin, MD, Study director, UMKC Department of Orthopaedic SurgeryKaren Williams, PhD, Study director, UMKC Dept of BioinformaticsNkem Egekeze, MD, Principal investigator, UMKC Dept of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416505
- Sponsor's protocol ID
- 14-334
- Status last verified
- Oct 2016
- First submitted
- 6 Apr 2015
- Last updated
- 4 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
- ClinicalTrials.gov ID
- NCT02416505
- Acronym / sponsor ID
- 14-334
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- First posted
- 15 Apr 2015 (estimated)
- 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.
This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial.
In this study, the investigators aim to evaluate the impact of a visual aid on patient comprehension an orthopedic informed consent discussion in low socioeconomic populations.
The primary outcome is patient comprehension measured by a Validated Knowledge-Based Multiple Choice Questionnaire.
The secondary outcomes include: Patient satisfaction and Time efficiency.
The investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic informed consent discussion will improve patient comprehension, satisfaction and time-efficiency of orthopedic care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verbal Discussion: Control Group | No intervention | –In this group, participants will receive a 10 minute Verbal Only Knee Osteoarthritis Steroid Injection Informed Consent discussion. This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection. |
| Verbal+Anatomic Model | Active comparator | Behavioral: Verbal+Anatomic ModelThis intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Knee Model. This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection. |
| Verbal+Video Presentation | Active comparator | Behavioral: Verbal+VideoThis intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Video. This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients newly diagnosed with Knee Osteoarthritis managed with steroid injections
- Patients who express lack of knowledge regarding knee osteoarthritis (causes, diagnosis, treatment, anatomy)
- English speaking
- Patients that meet the Federal Poverty Guideline for Healthcare (i.e. Medicaid)
Key exclusion criteria (5 listed)
- Patients under the age of 18
- College graduates
- Non-English speaking
- Patient without the capacity to give consent
- Patients with a tactile, mental, visual or auditory disability
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 |
|---|---|---|
| Verbal+Anatomic Model | Behavioural | Verbal+Anatomic Model |
| Verbal+Video | Behavioural | Verbal+Video Presentation |
Primary outcome
The Nkem Test
Time frame: 20 minutes
Comprehension based examination of an informed consent discussion
1 secondary outcome
Patient Satisfaction Survey
Time frame: 5 minutes
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 4 Oct 2016.
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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.
Mark Bernhardt, MD study chair
UMKC Department of Orthopaedic Surgery
Johnathan Dubin, MD study director
UMKC Department of Orthopaedic Surgery
Karen Williams, PhD study director
UMKC Dept of Bioinformatics
Questions about this trial
What is this clinical trial studying?
A study testing Verbal+Anatomic Model and Verbal+Video in people with Knee Osteoarthritis, run by University of Missouri, Kansas City.
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 5 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The Nkem Test (time frame: 20 minutes). 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 4 Oct 2016.