Trial Outcomes & Findings for Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis (NCT NCT03245463)
NCT ID: NCT03245463
Last Updated: 2019-11-05
Results Overview
Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
1 month post-injection
Results posted on
2019-11-05
Participant Flow
Participant milestones
| Measure |
Teaching Method A
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.
Educational handout: The educational handout will include information on self-management strategies.
Hyaluronic Acid: 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.
|
Teaching Method B
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).
Educational handout: The educational handout will include information on self-management strategies.
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.
Hyaluronic Acid: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Teaching Method B
n=12 Participants
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).
Educational handout: The educational handout will include information on self-management strategies.
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.
Hyaluronic Acid: 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.
|
Total
n=24 Participants
Total of all reporting groups
|
Teaching Method A
n=12 Participants
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.
Educational handout: The educational handout will include information on self-management strategies.
Hyaluronic Acid: 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.
|
|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 13 • n=107 Participants
|
70 years
STANDARD_DEVIATION 10 • n=206 Participants
|
71 years
STANDARD_DEVIATION 8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
12 participants
n=99 Participants
|
|
Average pain
|
4.8 units on a 0-10 scale
STANDARD_DEVIATION 2.3 • n=107 Participants
|
5.2 units on a 0-10 scale
STANDARD_DEVIATION 2.2 • n=206 Participants
|
5.6 units on a 0-10 scale
STANDARD_DEVIATION 2.2 • n=99 Participants
|
PRIMARY outcome
Timeframe: 1 month post-injectionSatisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
Outcome measures
| Measure |
Teaching Method A
n=12 Participants
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.
Educational handout: The educational handout will include information on self-management strategies.
Hyaluronic Acid: 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.
|
Teaching Method B
n=12 Participants
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).
Educational handout: The educational handout will include information on self-management strategies.
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.
Hyaluronic Acid: 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.
|
|---|---|---|
|
Patient Satisfaction With the Teaching Method
|
8.8 units on a scale
Standard Deviation 1.6
|
8.3 units on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 1 month post-injectionSatisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
Outcome measures
| Measure |
Teaching Method A
n=12 Participants
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.
Educational handout: The educational handout will include information on self-management strategies.
Hyaluronic Acid: 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.
|
Teaching Method B
n=12 Participants
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).
Educational handout: The educational handout will include information on self-management strategies.
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.
Hyaluronic Acid: 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.
|
|---|---|---|
|
Provider Satisfaction With the Teaching Method
|
6.0 units on a scale
Standard Deviation 1.9
|
8.0 units on a scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 3 months post-injectionSatisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
Outcome measures
| Measure |
Teaching Method A
n=12 Participants
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.
Educational handout: The educational handout will include information on self-management strategies.
Hyaluronic Acid: 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.
|
Teaching Method B
n=12 Participants
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).
Educational handout: The educational handout will include information on self-management strategies.
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.
Hyaluronic Acid: 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.
|
|---|---|---|
|
Patient Satisfaction With the Teaching Method
|
8.6 units on a scale
Standard Deviation 2.2
|
8.6 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 3 months post-injectionPatient will be asked: "Would you have preferred a different method of receiving education?"
Outcome measures
| Measure |
Teaching Method A
n=12 Participants
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.
Educational handout: The educational handout will include information on self-management strategies.
Hyaluronic Acid: 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.
|
Teaching Method B
n=12 Participants
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).
Educational handout: The educational handout will include information on self-management strategies.
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.
Hyaluronic Acid: 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.
|
|---|---|---|
|
Number of Patients Who Would Have Preferred a Different Method of Receiving Education.
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months post-injectionPatient will be asked: "Did the education you received help with the care of your osteoarthritis?"
Outcome measures
| Measure |
Teaching Method A
n=12 Participants
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.
Educational handout: The educational handout will include information on self-management strategies.
Hyaluronic Acid: 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.
|
Teaching Method B
n=12 Participants
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).
Educational handout: The educational handout will include information on self-management strategies.
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.
Hyaluronic Acid: 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.
|
|---|---|---|
|
Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 3 months post-injectionThe physical health score will be surveyed using the PROMIS-10 global health questionnaire. A higher score indicates better physical health. Scores range from 16.2 to 67.7.
Outcome measures
| Measure |
Teaching Method A
n=12 Participants
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.
Educational handout: The educational handout will include information on self-management strategies.
Hyaluronic Acid: 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.
|
Teaching Method B
n=12 Participants
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).
Educational handout: The educational handout will include information on self-management strategies.
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.
Hyaluronic Acid: 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.
|
|---|---|---|
|
PROMIS Physical Health Score
|
45.8 score on a scale
Standard Deviation 5.1
|
48.4 score on a scale
Standard Deviation 6.5
|
Adverse Events
Teaching Method A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Teaching Method B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place