- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01618097
Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy
March 4, 2015 updated by: Duke University
The purpose of this study is to advance the evidence base regarding methods for facilitating informed decisions among patients with knee and hip osteoarthritis by comparing DVD and online formats of decision aids for these conditions.
The project will assess how these different formats impact key outcomes including: patient knowledge about treatment options, decisional conflict, preparation for decision making, decision self-efficacy, stage of decision making, and acceptability and usability of the decision aids.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of pain and disability.
Many patients with OA know very little about treatment options and are not well equipped to make informed decisions regarding these treatments.
Further, there are racial and gender disparities in perceptions of the risks and benefits of total joint replacement, which also highlights the need to improve facilitation of informed treatment choices in these patients.
Decision aids have great potential to improve patient satisfaction, safety, and outcomes for patients with OA, but there is no evidence base regarding best formats for delivering this information.
This project will compare patient decision-making outcomes immediately following viewing of DVD and web-based versions of the Health Dialog DAs for hip and knee OA, as well as three days and one month later.
Patients with symptomatic knee and hip OA (n=200) will be enrolled from a primary care and orthopedic clinics.
Participants will be randomized, with stratification according to health literacy level, to view the DVD or web-based DA.
Outcomes will include: Knowledge about OA and Treatments, Decisional Conflict, Preparation for Decision-Making, Decision Self-Efficacy, Stage of Decision Making, Acceptability and Usability of the DA, and home use of the DA.
This project will make a novel contribution with direct clinical applicability, providing information regarding best methods for disseminating tools to enhance informed decision-making among patients with hip and knee OA, with particular attention to patients with low literacy.
Study Type
Interventional
Enrollment (Actual)
155
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27701
- Duke University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinician diagnosis of knee/hip OA, based on radiographic evidence in Duke medical records.
- Moderate or worse current joint symptoms, assessed at telephone screening using standard items.
Exclusion Criteria:
- Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease.
- Active diagnosis of psychosis or dementia, or other cognitive impairment.
- Severe hearing or visual impairment that would prohibit effective use of the DAs.
- Planning, scheduled for or on a wait list for joint replacement surgery.
- Had a prior hip or knee joint replacement surgery.
- Inability to read English, since the DAs are in English.
- Current participation in another OA interventional study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DVD Decision Aid
Patient assigned to watch DVD decision aid.
|
Patients will receive the DVD decision aid to view, and follow up 3 days and 30 days post visit.
|
Experimental: Internet Based Decision Aid
Patient assigned to watch OA specific internet based decision aid.
|
Patients will receive the OA specific internet based decision aid to view, and follow up 3 days and 30 days post visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Facts about Osteoarthritis section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46) at Baseline to post.
Time Frame: Baseline and 1 hour
|
Knowledge is a key outcome in this study because it is fundamental to informed decision making process 45.
We will use the "Facts about Osteoarthritis" section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46), which includes 8 items that assess knowledge about the knee OA and its treatment options (behavioral, pharmacological, and surgical).
Although this instrument was developed for knee OA, the items are also appropriate for hip OA, and it will be used for both groups.
|
Baseline and 1 hour
|
Change in Decisional Conflict Scale at Baseline to post.
Time Frame: Baseline and 1 hour
|
We will use the Low Literacy version of this scale, which includes 10 items with 3 response categories (yes, no, unsure), across four subscales: Informed (do patients know the different options, benefits, and risks?),
Values Clarity (are patients clear about which benefits and risk matter most to them?), Support (do patients have support and advice to make a choice?), and Uncertainty (are patients clear or sure about what to choose?).
|
Baseline and 1 hour
|
Change in Decision Self-Efficacy Scale a Baseline to post.
Time Frame: Baseline and 1 hour
|
This is an 11-item scale that measures patients' confidence in completing various tasks related to the decision-making processes, such as getting facts about risks and benefits, asking questions, and expressing concerns.
All items are measured on a scale of 0 (not confident at all) to 4 (very confident).
|
Baseline and 1 hour
|
Change in the Facts about Osteoarthritis section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46) at 30 days.
Time Frame: Baseline and 30 days
|
Baseline and 30 days
|
|
Change in Decisional Conflict Scale at 30 days post.
Time Frame: Baseline and 30 days
|
Baseline and 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of the Acceptability and Usability Scale post viewing of the DAs.
Time Frame: Up to 1 hour
|
We will adapt a 10-item scale to assess the acceptability of this OA DAs.
This tool assesses patients' opinions of general aspects of the DA (e.g., amount of information, length), as well as specific topical areas of the DA.
In addition, for participants who are randomized to view the internet-based DA, we will use the Perceived Health Website Usability Questionnaire.
This questionnaire includes items that assess the ease of finding information, ease of reading, appearance, and ease of learning from the website.
|
Up to 1 hour
|
Semi-Structured Interviews
Time Frame: Up to 1 hour
|
We will use semi-structured interviews to assess patients' perceptions and opinions of the DAs.
Specific questions will be developed by the study team, covering the following topical areas: What participants liked about the DA, how well it answered questions they had about treatment options, any additional information to inform their decision-making, other suggestions for improving the DA, likelihood of using the DA to obtain information about treatment options, and how beneficial they think it would be to talk with a nurse / health educator about this information after viewing the DA.
|
Up to 1 hour
|
Time spent viewing different parts of the internet-based DA
Time Frame: Up to 1 hour
|
Installation of Spector Pro software onto the laptop computer on which participants will view the DA to capture information about participants' viewing of the DA.
Descriptive data will be generated.
Main variables we plan to evaluate are: 1.)
The proportion of patients who view each page of the website.
2.) The mean or median number of minutes patients spent on each page.
3.) The proportion of patients who view video(s) within the DA.
We will also compare these variables according to patient characteristics and changes in study outcomes.
|
Up to 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kelli D Allen, PhD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
May 29, 2012
First Submitted That Met QC Criteria
June 11, 2012
First Posted (Estimate)
June 13, 2012
Study Record Updates
Last Update Posted (Estimate)
March 5, 2015
Last Update Submitted That Met QC Criteria
March 4, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00032794
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Mayo ClinicCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
Sword Health, SAHospital da PreladaCompletedEfficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint ReplacementKnee Osteoarthritis | Hip OsteoarthritisPortugal
-
The Hawkins FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
Massachusetts General HospitalNewton-Wellesley HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on DVD Decision Aid
-
University of MichiganNational Cancer Institute (NCI)Completed
-
M.D. Anderson Cancer CenterPatient-Centered Outcomes Research InstituteCompletedSmoking Cessation | Lung Cancer | Tobacco Use CessationUnited States
-
University of LeedsBaxter Healthcare Corporation; National Health Service, United Kingdom; Foundation... and other collaboratorsCompletedChronic Kidney FailureUnited Kingdom
-
Massachusetts General HospitalCompletedCoronary Artery Disease | Stable AnginaUnited States
-
University Hospital HeidelbergInnovationsfonds des Gemeinsamen Bundesausschusses, GermanyCompletedPatient Decision Aid | Treatment As UsualGermany
-
Case Comprehensive Cancer CenterCompletedProstate CancerUnited States
-
Massachusetts General HospitalUnknownDecision Making | Video Decision AidsUnited States
-
Kaiser PermanenteFoundation for Informed Medical Decision MakingCompletedObesity | Obesity, Morbid | Bariatric Surgery | Decision AidsUnited States
-
University of UtahPatient-Centered Outcomes Research Institute; Mayo Clinic; Northwestern University and other collaboratorsActive, not recruitingAtrial FibrillationUnited States
-
Massachusetts General HospitalCompleted