Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy
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|ClinicalTrials.gov Identifier: NCT01618097|
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : March 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Behavioral: DVD Decision Aid Behavioral: Internet Based Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||155 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||January 2014|
Experimental: DVD Decision Aid
Patient assigned to watch DVD decision aid.
Behavioral: 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.
Behavioral: 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
- 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 ]
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618097
|United States, North Carolina|
|Durham, North Carolina, United States, 27701|
|Principal Investigator:||Kelli D Allen, PhD||Duke University|