Trial Outcomes & Findings for Educational Intervention for Knee Pain (NCT NCT00324857)
NCT ID: NCT00324857
Last Updated: 2018-10-10
Results Overview
Change in willingness assessed using the willingness likert scale. The primary outcome was change in patient willingness to undergo total knee replacement. The willingness rating is a 5-category ordinal response scale from "definitely not willing" to "definitely willing" which was later dichotomized for analysis. Responses "definitely" and "probably willing" were combined and compared to "unsure", "probably not willing", and "definitely not willing" combined.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
663 participants
Primary outcome timeframe
Follow-Up
Results posted on
2018-10-10
Participant Flow
Participant milestones
| Measure |
Arm 1/Attention Control
Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
|
Arm 2/Decision Aid (DA)
Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled "Treatment Choices for Knee Osteoarthritis." The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.
|
Arm 3/ Motivational Interview (MI)
Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
|
Arm 4/ DA and MI
Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled "Treatment Choices for Knee Osteoarthritis." The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.
Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
167
|
168
|
165
|
163
|
|
Overall Study
COMPLETED
|
161
|
162
|
158
|
158
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Educational Intervention for Knee Pain
Baseline characteristics by cohort
| Measure |
Arm 1/Attention Control
n=161 Participants
Attention control
|
Arm 2/Decision Aid (DA)
n=162 Participants
Decision Aid video
|
Arm 3/ Motivational Interview (MI)
n=158 Participants
Motivational Interviewing
|
Arm 4/ DA and MI
n=158 Participants
Decision aid and MI
|
Total
n=639 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 8 • n=5 Participants
|
61 years
STANDARD_DEVIATION 9 • n=7 Participants
|
61 years
STANDARD_DEVIATION 9 • n=5 Participants
|
61 years
STANDARD_DEVIATION 8 • n=4 Participants
|
61 years
STANDARD_DEVIATION 8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
639 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
161 participants
n=5 Participants
|
162 participants
n=7 Participants
|
158 participants
n=5 Participants
|
158 participants
n=4 Participants
|
639 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Follow-UpPopulation: Study sample reflects the African American, predominantly male population of the VA health care system
Change in willingness assessed using the willingness likert scale. The primary outcome was change in patient willingness to undergo total knee replacement. The willingness rating is a 5-category ordinal response scale from "definitely not willing" to "definitely willing" which was later dichotomized for analysis. Responses "definitely" and "probably willing" were combined and compared to "unsure", "probably not willing", and "definitely not willing" combined.
Outcome measures
| Measure |
Arm 1/Attention Control
n=161 Participants
Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
|
Arm 2/Decision Aid (DA)
n=162 Participants
Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled "Treatment Choices for Knee Osteoarthritis." The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.
|
Arm 3/ Motivational Interview (MI)
n=158 Participants
Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
|
Arm 4/ DA and MI
n=158 Participants
Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled "Treatment Choices for Knee Osteoarthritis." The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.
Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
|
|---|---|---|---|---|
|
Change in Willingness.
1 Month Follow-Up
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Change in Willingness.
3 Month Follow-Up
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Change in Willingness.
12 Month Follow-Up
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The data were not collected and therefore not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1/Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2/Decision Aid (DA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3/ Motivational Interview (MI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4/ DA and MI
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