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 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.	Total n=24 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 8 • n=5 Participants	69 years STANDARD_DEVIATION 13 • n=7 Participants	70 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Average pain	5.6 units on a 0-10 scale STANDARD_DEVIATION 2.2 • n=5 Participants	4.8 units on a 0-10 scale STANDARD_DEVIATION 2.3 • n=7 Participants	5.2 units on a 0-10 scale STANDARD_DEVIATION 2.2 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month post-injection

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.

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-injection

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.

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-injection

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.

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-injection

Patient 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-injection

Patient 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-injection

The 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

Dr. James Wyss

Hospital for Special Surgery

Phone: 2126061731

Email: wyssj@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place