OsteoarthritisNCT01618097
Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy
A study testing DVD Decision Aid and Internet Based Decision Aid in people with Osteoarthritis, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- DVD Decision Aid and Internet Based Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2014
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- DVD Decision Aid, Internet Based Decision Aid
- Keywords
- Osteoarthritis, Decision Aids, Health Literacy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVD Decision AidBehavioural
Patients will receive the DVD decision aid to view, and follow up 3 days and 30 days post visit.
Internet Based Decision AidBehavioural
Patients will receive the OA specific internet based decision aid to view, and follow up 3 days and 30 days post visit
| Study group | Role | What they receive |
|---|---|---|
| DVD Decision Aid | Experimental | Patient assigned to watch DVD decision aid. Receives: Behavioral: DVD Decision Aid |
| Internet Based Decision Aid | Experimental | Patient assigned to watch OA specific internet based decision aid. Receives: Behavioral: Internet Based Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Baseline and 1 hour
Change in Decisional Conflict Scale at Baseline to post.
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?).
Measured: Baseline and 1 hour
Change in Decision Self-Efficacy Scale a Baseline to post.
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).
Measured: 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.
Measured: Baseline and 30 days
Change in Decisional Conflict Scale at 30 days post.
Measured: Baseline and 30 days
Secondary outcomes (3)
Measurement of the Acceptability and Usability Scale post viewing of the DAs.
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.
Measured: Up to 1 hour
Semi-Structured Interviews
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.
Measured: Up to 1 hour
Time spent viewing different parts of the internet-based DA
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.
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionJan 2014
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 OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making
- Responsible party
- Sponsor
- Investigators
- Kelli D Allen, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618097
- Sponsor's protocol ID
- Pro00032794
- Status last verified
- Mar 2015
- First submitted
- 29 May 2012
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Allen, K.D., Sanders, L. Olsen, M., Bowlby, L., Katz, J.N., Mather, R.C., Powers, B., Sperber, N., Voils, C.I., Williams, J.W. Effectiveness of Internet and DVD Decision Aids for Patients with Hip and Knee Osteoarthritis. April 2014 World Congress on Osteoarthritis. Paris, France.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy
- ClinicalTrials.gov ID
- NCT01618097
- Acronym / sponsor ID
- Pro00032794
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Decision Aids, Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Jun 2012 (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 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DVD Decision Aid | Experimental | Behavioral: DVD Decision AidPatient assigned to watch DVD decision aid. |
| Internet Based Decision Aid | Experimental | Behavioral: Internet Based Decision AidPatient assigned to watch OA specific internet based decision aid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| DVD Decision AidPatients will receive the DVD decision aid to view, and follow up 3 days and 30 days post visit. | Behavioural | DVD Decision Aid |
| Internet Based Decision AidPatients will receive the OA specific internet based decision aid to view, and follow up 3 days and 30 days post visit | Behavioural | Internet Based Decision Aid |
Primary outcome
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.
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?).
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).
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
Change in Decisional Conflict Scale at 30 days post.
Time frame: Baseline and 30 days
3 secondary outcomes
Measurement of the Acceptability and Usability Scale post viewing of the DAs.
Time frame: Up to 1 hour
Semi-Structured Interviews
Time frame: Up to 1 hour
Time spent viewing different parts of the internet-based DA
Time frame: Up to 1 hour
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 5 Mar 2015.
- Results publicationAllen, K.D., Sanders, L. Olsen, M., Bowlby, L., Katz, J.N., Mather, R.C., Powers, B., Sperber, N., Voils, C.I., Williams, J.W. Effectiveness of Internet and DVD Decision Aids for Patients with Hip and Knee Osteoarthritis. April 2014 World Congress on Osteoarthritis. Paris, France.
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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.
Kelli D Allen, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVD Decision Aid and Internet Based Decision Aid in people with Osteoarthritis, run by Duke University 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 2 inclusion and 7 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 5 Mar 2015. 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?
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). The study lists 5 primary outcomes in all. 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 NCT01618097, 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 5 Mar 2015.