Clinical trial NCT03245463
Conditions: Osteoarthritis, Knee
Sponsor: Hospital for Special Surgery, New York
Start date: 2017-08-09; Completion date: 2018-02-13
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence, and even safety of the individuals who suffer from it. One of the most powerful tools for these patients can be education on self-care and self-management strategies that can be taught to a patient by a physician, physical or occupational therapist, or a nurse. These self-management strategies can help patients treat daily stiffness through exercise or manage flares of osteoarthritis. There is a lack of consensus on the best teaching methods to accomplish the goal of educating our patients. Feedback from both patients and providers regarding teaching methods is needed. This study will evaluate teaching methods on self-management strategies for patients who are undergoing hyaluronic acid injections for knee osteoarthritis.

Detailed description:

Arms: arm 1: Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions. arm 2: Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).
Interventions: intervention 1: Educational handout intervention 2: Verbal script intervention 3: Hyaluronic Acid
Intervention descriptions: intervention 1: The educational handout will include information on self-management strategies. intervention 2: The verbal script will include details on self-management strategies that will be reviewed with the patient. intervention 3: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.

Protocol documents:
Prot_SAP_000.pdf: 
 
TITLE: Evaluation of two different methods of teaching self-
management strategies to patients with symptomatic knee osteoarthritis 
 
NCT: 03245463 
 
DOCUMENT DATE: July 25, 2017 
 
 
 


Title: Evaluation of two different methods of teaching self-management strategies to patients 
with symptomatic knee osteoarthritis  
 
Principal Investigator: Dr. James Wyss, MD  
 
Condition or Intervention to be studied: The condition being studied is self-management 
education for patients who have symptomatic knee osteoarthritis (OA) and are scheduled for a 
hyaluronic acid (HA) injection.  
 
Research questions/specific aims: This is a pilot study to evaluate two different teaching 
methods of self-management education to patients receiving an HA injection for symptomatic 
knee OA. The main goal is to see if the study can be feasibly conducted. Feasibility will be 
determined by availability of the fellows/residents to administer the assigned teaching method to 
the potential patient (if they are unavailable 70% of the time, then the study will be deemed to be 
not feasible). The other goals are to obtain information on the following:  
1. Patient satisfaction with their assigned teaching methods.  
2. Education methods that are preferred by patients.  
3. Provider (fellows and residents) satisfaction with their assigned teaching methods.  
4. Teaching methods that are preferred by fellows and residents.  
 
Hypothesis: We hypothesize that the study can be feasibly conducted, and that patient 
satisfaction with assigned teaching method 2 (education handout + 5-minute explanation) will be 
higher than patient satisfaction with assigned teaching method A (educational handout only, no 
explanation).  
 
Primary outcome:  
1. Patient satisfaction with their assigned teaching method (0-10 scale; 0=not satisfied; 
10=most satisfied) – assessed at 1 and 3 months post-injection  
2. Provider (fellow, resident) satisfaction with their assigned teaching method (0-10 scale; 
0=not satisfied; 10=most satisfied) – assessed at 1 and 3 months post-injection  
 
Secondary outcomes:  
1. Patient preference regarding teaching method – assessed at 1 and 3 months post-injection  
2. Provider preference regarding teaching method – assessed at 1 month post-injection  
3. Quality of education on post-injection care – assessed at 1 and 3 months post-injection  
4. PROMIS-10 – assessed at 1 and 3 months post-injection  
 
Background: Symptomatic knee OA is a condition that is characterized by frequent pain to the 
joint and affects approximately 10 million adults in the United States.1 By age 60, the lifetime 
risk of being diagnosed with symptomatic knee OA is 9.29%.2 Increases in symptomatic knee 
OA pain have been associated with higher BMI, greater comorbidity, and lower level of 
education.3 For patients who do not want to have surgery, treatment options include 
pharmacologic injections, physical therapy, and medications, with the goal of relieving 
symptoms, improving quality of life, and restoring physical function. Regardless of treatment 
type, achieving the abovementioned goals requires self-management.  
In 2003, the EULAR consensus stated that patient education should be provided to 
patients with symptomatic knee OA to help them understand and self-manage their condition.4 


However, there is a lack of consensus on the best teaching methods to educate our patients with 
symptomatic knee OA on self-management strategies. Different physician practices within a 
department or across different departments utilize different strategies to accomplish these goals. 
Many provide direct doctor-to-patient teaching that may occur during an office visit (one-on-
one) or with a small group. Others may rely on educational handouts or other forms of individual 
education that are given to patients. Some utilize both methods of teaching, and others rely on 
physical therapists to provide this education to their patients as part of their physical therapy 
program. There are many other teaching methods, and variations of previous methods also exist.5  
Numerous studies on different patient education methods in various patient populations 
have been conducted.6 Both the content and delivery of education materials are essential to 
having a successful method. Whether one method is effective depends largely on the patient’s 
self-efficacy, ability to understand the materials, and willingness to cooperate.7,8 This is 
especially key to having success with self-management protocols. Any stress that may result 
from an ineffective education tool can also adversely affect a patient’s outcomes.7 In the general 
OA population, Hansson et al. demonstrated an increase in self-perceived health in patients who 
participated in an OA-targeted patient education program (5 group sessions) compared to 
patients who did not participate in the program.9 However, no differences in self-efficacy were 
observed, and patient satisfaction was not assessed. A review by Brand et al. in 2013 showed 
improvements in self-efficacy with regard to decreasing pain in arthritis patients receiving self-
management education, although these effect sizes were very small and likely not statistically 
significant in some cases.8 Again, many of these studies did not assess patient satisfaction.  
Recently, the development of video-based patient education tools was tested in patients with 
knee osteoarthritis (both symptomatic and not), rheumatoid arthritis, and osteoporosis. The 
results showed increases in disease knowledge, and patients appeared to be more aware about 
taking their medications.10 Future advances in patient education are likely to incorporate 
multimedia tools as a way to better engage the patient.  
With all this being said, studies that are focused on patient education involving self-
management methods in the symptomatic knee OA population are lacking. A literature search 
revealed one study looking at the effects of an 8-week multimodal treatment program that 
improved symptoms of symptomatic knee OA. Patient education was a component of the 
treatment program, but whether it specifically contributed to symptom improvement is 
unknown.11 Given the degree of disability that these patients live with on a daily basis, clarifying 
the proper method of self-management education is important. This pilot study aims to take the 
first step at evaluating two different methods of teaching: one involving a written handout that's 
given to the patient for him/her to read at home, and one involving the same written handout that 
is explained to the patient by the provider. Future studies will evaluate other commonly utilized 
methods of teaching, as well as longer periods of follow-up.  
 
1. Lawrence RC, et al. Estimates of the prevalence of arthritis and other rheumatic 
conditions in the United States, part II. Arthritis Rheum. 2008 Jan;58(1):26-35. 
2. Losina E, et al. Lifetime risk and age of diagnosis of symptomatic knee osteoarthritis in 
the US. Arthritis Care Res. 2013 May;65(5). 
3. Bastick AN, et al. Defining knee pain trajectories in early symptomatic knee 
osteoarthritis in primary care: 5-year results from a nationwide prospective cohort study 
(CHECK). Br J Gen Pract. 2016 Jan;66(642):e32-9. 
4. Jordan KM, et al. EULAR Recommendations 2003: an evidence-based approach to the 
management of knee osteoarthritis: report of a task force of the standing committee for 


international clinical studies including therapeutic trials (ESCISIT). Ann Rheum Dis. 
2003 Dec;62(12):1145-55. 
5. Schrieber L, et al. Patient education. Best Prac Res Clin Rheum. 2004;18(4):465-476. 
6. Friedman AJ, et al. Effective teaching strategies and methods of delivery for patient 
education: a systematic review and practice guideline recommendations. J Cancer Educ. 
2011 Mar;26(1):12-21. 
7. Koehn CL, et al. Patient education and self-management of musculoskeletal diseases. 
Best Prac Res Clin Rheum. 2008;22(3):395-405. 
8. Brand E, et al. Arthritis self-efficacy scale scores in knee osteoarthritis: a systematic 
review and meta-analysis comparing arthritis self-management education with or without 
exercise. J Orthop Sports Phys Ther. 2013 Dec;43(12):895-910. 
9. Hansson EE, et al. Effect of an education programme for patients with osteoarthritis in 
primary care – a randomized controlled trial. BMC Musculoskelet Dis. 2010;11:244. 
10. Lopez-Olivo MA, et al. Development and pilot testing of multimedia patient education 
tools for patients with knee osteoarthritis, osteoporosis, and rheumatoid arthritis. Arthritis 
Care Res. 2017. 
11. Miller LE, et al. An 8-week multimodal treatment program improves symptoms of knee 
osteoarthritis: a real-world multicenter experience. Pragmat Obs Res. 2013;4:39-44. 
 
Study design: Randomized controlled clinical trial 
 
Enrollment target: 24 
 
Inclusion criteria: 
1. Age 18+ 
2. Diagnosis of symptomatic knee OA 
3. Scheduled for an HA injection into the knee 
4. Fellow/resident is available to administer assigned teaching method 
 
Exclusion criteria: 
1. Patients who are already enrolled in the study 
2. Non-English speaking 
 
Study procedures: Patients who have symptomatic knee OA and are coming in for an HA 
injection will be approached for the study. At the time of consent, patients will be told that they 
will be receiving educational materials, and that the study will be focusing on outcomes in 
patients who receive educational materials. Details related to the two teaching methods will only 
be revealed to the patients at the 3-month follow-up, in order to prevent any bias in their 
responses. The primary investigator and research assistant will be blinded to the randomization 
group. 
 
Enrolled patients will be randomized to receive one of two teaching methods: 
1. A written handout will be given to the patient, and the patient will be asked to read the 
handout at home and call back with any questions or clarifications. 
2. A written handout will be given to the patient, and key information will be explained to 
the patient with time for questions and answers (approximately 5 min). 
The written handout includes a description of knee OA, treatment options for knee OA, and 
instructions for the self-management of knee OA. 


 
During the icing period post-injection, a fellow or resident will return to the exam room and 
administer either teaching method 1 or 2 to the patient (depending on the randomization 
assignment). The same written handout will be given to every patient. The explanation of key 
information will be standardized as much as possible to prevent against large variations in 
teaching methods among fellows and residents. 
 
At 1 month following the educational handout/session, the fellows and residents will be surveyed 
regarding their satisfaction with the teaching method and if they would have preferred to teach 
the information in a different manner. 
 
At 1 month and 3 months following the educational handout/sessions, patients will be asked the 
following questions: 
1. On a scale of 0-10, with 0=not satisfied and 10=most satisfied, please rate your 
satisfaction with the education you received on the day of your injection. 
2. Would you have preferred a different method of receiving education? If yes, what 
method? 
3. Did the education you received help with the care of your osteoarthritis? If yes, please 
explain how it helped. 
4. PROMIS-10 questionnaire (also administered at baseline, after consent) 
 
Sample size analysis and statistical analysis plan: As recommended by Julius,1 this pilot study 
will have a sample size of 12 per group (24 total). If deemed feasible, results from this study will 
be used to design larger, future studies. 
 
Descriptive statistics will be employed for this pilot study. Patient/provider satisfaction results 
will be summarized as mean with standard deviation or median with 1st and 3rd quartiles. 
Patient/provider preference results (yes/no) will be presented as counts and percentages. Whether 
the education helped with the patient’s care of OA (yes/no) will also be presented as counts and 
percentages. PROMIS-10 scores will be summarized as mean with standard deviation or median 
with 1st and 3rd quartiles. Comparisons between continuous or categorical variables will be 
assessed using the Student’s t-test or Chi-square test, respectively. 
 
1. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut 
Statist. 2005 Oct;4(4):287-291. 


12. Lawrence RC, et al. Estimates of the prevalence of arthritis and other rheumatic 
conditions in the United States, part II. Arthritis Rheum. 2008 Jan;58(1):26-35.  


13.  


14. Losina E, et al. Lifetime risk and age of diagnosis of symptomatic knee osteoarthritis in 
the US. Arthritis Care Res. 2013 May;65(5).  
3. Bastick AN, et al. Defining knee pain trajectories in early symptomatic knee osteoarthritis in 
primary care: 5-year results from a nationwide prospective cohort study (CHECK). Br J Gen 
Pract. 2016 Jan;66(642):e32-9.  
4. Jordan KM, et al. EULAR Recommendations 2003: an evidence-based approach to the 
management of knee osteoarthritis: report of a task force of the standing committee for 
international clinical studies including therapeutic trials (ESCISIT). Ann Rheum Dis. 2003 
Dec;62(12):1145-55.  
5. Schrieber L, et al. Patient education. Best Prac Res Clin Rheum. 2004;18(4):465-476.  
6. Friedman AJ, et al. Effective teaching strategies and methods of delivery for patient education: 
a systematic review and practice guideline recommendations. J Cancer Educ. 2011 
Mar;26(1):12-21.  
7. Koehn CL, et al. Patient education and self-management of musculoskeletal diseases. Best 
Prac Res Clin Rheum. 2008;22(3):395-405.  
8. Brand E, et al. Arthritis self-efficacy scale scores in knee osteoarthritis: a systematic review 
and meta-analysis comparing arthritis self-management education with or without exercise. J 
Orthop Sports Phys Ther. 2013 Dec;43(12):895-910.  
9. Hansson EE, et al. Effect of an education programme for patients with osteoarthritis in 
primary care - a randomized controlled trial. BMC Musculoskelet Dis. 2010;11:244.  
10. Lopez-Olivo MA, et al. Development and pilot testing of multimedia patient education tools 
for patients with knee osteoarthritis, osteoporosis, and rheumatoid arthritis. Arthritis Care Res. 
2017.  
11. Miller LE, et al. An 8-week multimodal treatment program improves symptoms of knee 
osteoarthritis: a real-world multicenter experience. Pragmat Obs Res. 2013;4:39-44.  
 
Study design: Randomized controlled clinical trial  
 
Enrollment target: 24  
 
Inclusion criteria:  
1. Age 18+  
2. Diagnosis of symptomatic knee OA  
3. Scheduled for an HA injection into the knee  
4. Fellow/resident is available to administer assigned teaching method  
 
Exclusion criteria:  
1. Patients who are already enrolled in the study  
2. Non-English speaking  
 
Study procedures: Patients who have symptomatic knee OA and are coming in for an HA 
injection will be approached for the study. At the time of consent, patients will be told that they 
will be receiving educational materials, and that the study will be focusing on outcomes in 
patients who receive educational materials. Details related to the two teaching methods will only 
be revealed to the patients at the 3-month follow-up, in order to prevent any bias in their  


responses. The primary investigator and research assistant will be blinded to the randomization 
group.  
Enrolled patients will be randomized to receive one of two teaching methods:  
1. A written handout will be given to the patient, and the patient will be asked to read the 
handout at home and call back with any questions or clarifications.  
2. A written handout will be given to the patient, and key information will be explained to the 
patient with time for questions and answers (approximately 5 min).  
 
The written handout includes a description of knee OA, treatment options for knee OA, and 
instructions for the self-management of knee OA.  
During the icing period post-injection, a fellow or resident will return to the exam room and 
administer either teaching method 1 or 2 to the patient (depending on the randomization 
assignment). The same written handout will be given to every patient. The explanation of key 
information will be standardized as much as possible to prevent against large variations in 
teaching methods among fellows and residents.  
At 1 month following the educational handout/session, the fellows and residents will be surveyed 
regarding their satisfaction with the teaching method and if they would have preferred to teach 
the information in a different manner.  
At 1 month and 3 months following the educational handout/sessions, patients will be asked the 
following questions:  
1. On a scale of 0-10, with 0=not satisfied and 10=most satisfied, please rate your satisfaction 
with the education you received on the day of your injection.  
2. Would you have preferred a different method of receiving education? If yes, what method?  
3. Did the education you received help with the care of your osteoarthritis? If yes, please explain 
how it helped.  
4. PROMIS-10 questionnaire (also administered at baseline, after consent)  
 
Sample size analysis and statistical analysis plan: As recommended by Julious (1), this pilot 
study will have a sample size of 12 per group (24 total). If deemed feasible, results from this 
study will be used to design larger, future studies.  
Descriptive statistics will be employed for this pilot study. Patient/provider satisfaction results 
will be summarized as mean with standard deviation or median with 1st and 3rd quartiles. 
Patient/provider preference results (yes/no) will be presented as counts and percentages. Whether 
the education helped with the patient’s care of OA (yes/no) will also be presented as counts and 
percentages. PROMIS-10 scores will be summarized as mean with standard deviation or median 
with 1st and 3rd quartiles. Comparisons between continuous or categorical variables will be 
assessed using the Student’s t-test or Chi-square test, respectively.  
1. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut Statist. 
2005 Oct;4(4):287-291.