Knee OsteoarthritisNCT02694237
The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent in a Private Practice
A study testing Model, Knee Anatomy Video and Verbal in people with Knee Osteoarthritis, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
The aim of the study is determine which method of informed consent improves comprehension in college educated patients in a private practice setting. 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?
- Model, Knee Anatomy Video and Verbal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Apr 2016
- 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
- Knee osteoarthritis patients over the age of 18 with a college education deemed appropriate for medical management with a knee injection.
Who cannot join
- Patients without the capacity to provide consent
- Patients with a visual, auditory, psychological or tactile impairment requiring the assistance of another person.
Trial locations and contacts
1 site in 1 country.
United States1 site
Truman Medical Center and Dickson-Diveley Orthopaedic Clinic
Kansas City, Missouri, 64108
About this study
The aim of the study is determine which method of informed consent improves comprehension in college educated patients in a private practice setting.
- Conditions
- Knee Osteoarthritis
- Being tested
- Model, Knee Anatomy Video, Verbal
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModelBehavioural
Each participant will receive an informed consent discussion with the aid of an anatomic knee model.
Knee Anatomy VideoBehavioural
Each participant will hear a scripted informed consent discussion while they watch a knee anatomy video orated by an interviewer.
VerbalBehavioural
Each participant will receive a verbal informed consent discussion without a visual aid.
| Study group | Role | What they receive |
|---|---|---|
| Verbal | Active comparator | This group will only receive a verbal discussion based on the same script used for all three groups. This is the control group. Receives: Behavioral: Verbal |
| Verbal + Model | Active comparator | This group will receive a verbal discussion aided with an anatomic model intervention that group participants will be able to touch throughout the discussion. Receives: Behavioral: Model |
| Verbal + Video | Active comparator | This group will receive a verbal discussion aided with a knee anatomy video intervention that will be played on silent an orated by an interviewer. Receives: Behavioral: Knee Anatomy Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Nkem Test
This knowledge based questionnaire assesses patient comprehension of an informed consent discussion. The score of the test is known as "The Nkem Score".
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 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
- Nkem Egekeze, MD, Principal investigator, UMKC Department of Orthopaedic SurgeryKaren Williams, PhD, Study director, UMKC Department of Health Insight and ResearchLuv Singh, MD, Study director, UMKC Department of Orthopaedic SurgeryDan Gurba, MD, Study director, Dickson-Diveley Orthopaedic ClinicCharles Rhoades, MD, Study director, UMKC Department of Orthopaedic SurgeryMark Bernhardt, MD, Study chair, UMKC Dept of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694237
- Sponsor's protocol ID
- OrthoInfo
- Status last verified
- Apr 2016
- First submitted
- 18 Feb 2016
- Last updated
- 2 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 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 in a Private Practice
- ClinicalTrials.gov ID
- NCT02694237
- Acronym / sponsor ID
- OrthoInfo
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- First posted
- 29 Feb 2016 (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.
The aim of the study is determine which method of informed consent improves comprehension in college educated patients in a private practice setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verbal | Active comparator | Behavioral: VerbalThis group will only receive a verbal discussion based on the same script used for all three groups. This is the control group. |
| Verbal + Model | Active comparator | Behavioral: ModelThis group will receive a verbal discussion aided with an anatomic model intervention that group participants will be able to touch throughout the discussion. |
| Verbal + Video | Active comparator | Behavioral: Knee Anatomy VideoThis group will receive a verbal discussion aided with a knee anatomy video intervention that will be played on silent an orated by an interviewer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Knee osteoarthritis patients over the age of 18 with a college education deemed appropriate for medical management with a knee injection.
Key exclusion criteria (2 listed)
- Patients without the capacity to provide consent
- Patients with a visual, auditory, psychological or tactile impairment requiring the assistance of another person.
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 |
|---|---|---|
| ModelEach participant will receive an informed consent discussion with the aid of an anatomic knee model. | Behavioural | Verbal + Model |
| Knee Anatomy VideoEach participant will hear a scripted informed consent discussion while they watch a knee anatomy video orated by an interviewer. | Behavioural | Verbal + Video |
| VerbalEach participant will receive a verbal informed consent discussion without a visual aid. | Behavioural | Verbal |
Primary outcome
The Nkem Test
Time frame: baseline
This knowledge based questionnaire assesses patient comprehension of an informed consent discussion. The score of the test is known as "The Nkem Score".
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 2 May 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.
Nkem Egekeze, MD principal investigator
UMKC Department of Orthopaedic Surgery
Karen Williams, PhD study director
UMKC Department of Health Insight and Research
Luv Singh, MD study director
UMKC Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model, Knee Anatomy Video and Verbal in people with Knee Osteoarthritis, run by University of Missouri, Kansas City at 1 site in United States.
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 1 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 2 May 2016. 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 United States. 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. 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: baseline). 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 2 May 2016.