Trial Outcomes & Findings for Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis (NCT NCT01192516)
NCT ID: NCT01192516
Last Updated: 2015-04-07
Results Overview
This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
195 participants
Primary outcome timeframe
Baseline
Results posted on
2015-04-07
Participant Flow
Potential participants were recruited through fliers and advertisements.
Participant milestones
| Measure |
Tailored Activity Pacing
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
Participants receiving usual care
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
63
|
|
Overall Study
COMPLETED
|
46
|
49
|
55
|
|
Overall Study
NOT COMPLETED
|
20
|
17
|
8
|
Reasons for withdrawal
| Measure |
Tailored Activity Pacing
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
Participants receiving usual care
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
1
|
|
Overall Study
started new treatment
|
5
|
1
|
0
|
|
Overall Study
Unable to follow Actiwatch instructions
|
4
|
2
|
0
|
Baseline Characteristics
Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis
Baseline characteristics by cohort
| Measure |
Arm 1
n=66 Participants
Tailored activity pacing
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
Arm 2
n=66 Participants
General activity pacing and symptom management
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Arm 3
n=63 Participants
Usual care group
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
66 participants
n=7 Participants
|
63 participants
n=5 Participants
|
195 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselineThis is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.
Outcome measures
| Measure |
Tailored Activity Pacing
n=66 Participants
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
n=66 Participants
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
n=63 Participants
Participants receiving usual care
|
|---|---|---|---|
|
Fatigue- Brief Fatigue Inventory (BFI)
|
3.06 units on a scale
Standard Deviation 2.34
|
3.18 units on a scale
Standard Deviation 2.45
|
2.70 units on a scale
Standard Deviation 2.31
|
PRIMARY outcome
Timeframe: 10 weeks post-baselinePopulation: Sample numbers may differ due to missing data
This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.
Outcome measures
| Measure |
Tailored Activity Pacing
n=49 Participants
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
n=50 Participants
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
n=60 Participants
Participants receiving usual care
|
|---|---|---|---|
|
Fatigue-BFI
|
3.35 units on a scale
Standard Deviation 2.13
|
3.09 units on a scale
Standard Deviation 2.14
|
2.98 units on a scale
Standard Deviation 2.28
|
PRIMARY outcome
Timeframe: 6 months post-baselinePopulation: Sample numbers may vary due to missing data
This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue.
Outcome measures
| Measure |
Tailored Activity Pacing
n=46 Participants
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
n=48 Participants
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
n=54 Participants
Participants receiving usual care
|
|---|---|---|---|
|
Fatigue-BFI
|
3.30 units on a scale
Standard Deviation 2.36
|
2.90 units on a scale
Standard Deviation 1.98
|
2.83 units on a scale
Standard Deviation 2.26
|
PRIMARY outcome
Timeframe: BaselineThis is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain.
Outcome measures
| Measure |
Tailored Activity Pacing
n=63 Participants
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
n=66 Participants
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
n=63 Participants
Participants receiving usual care
|
|---|---|---|---|
|
Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
8.23 units on a scale
Standard Deviation 2.99
|
8.19 units on a scale
Standard Deviation 3.37
|
8.27 units on a scale
Standard Deviation 3.32
|
PRIMARY outcome
Timeframe: 10 weeks post-baselinePopulation: Sample numbers may differ due to missing data
This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.
Outcome measures
| Measure |
Tailored Activity Pacing
n=49 Participants
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
n=50 Participants
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
n=60 Participants
Participants receiving usual care
|
|---|---|---|---|
|
Pain- WOMAC
|
8.10 units on a scale
Standard Deviation 3.43
|
7.16 units on a scale
Standard Deviation 3.11
|
7.83 units on a scale
Standard Deviation 3.46
|
PRIMARY outcome
Timeframe: 6 months post baselinePopulation: Numbers may vary due to missing data
This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.
Outcome measures
| Measure |
Tailored Activity Pacing
n=47 Participants
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
n=49 Participants
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
n=54 Participants
Participants receiving usual care
|
|---|---|---|---|
|
Pain- WOMAC
|
7.63 units on a scale
Standard Deviation 3.57
|
7.33 units on a scale
Standard Deviation 2.76
|
6.68 units on a scale
Standard Deviation 3.29
|
SECONDARY outcome
Timeframe: BaselinePopulation: Numbers may vary due to missing data
Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes
Outcome measures
| Measure |
Tailored Activity Pacing
n=66 Participants
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
n=66 Participants
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
n=62 Participants
Participants receiving usual care
|
|---|---|---|---|
|
Physical Function- Six Minute Walk
|
1185.3 feet
Standard Deviation 263.3
|
1208.6 feet
Standard Deviation 255.2
|
1209.4 feet
Standard Deviation 260.1
|
SECONDARY outcome
Timeframe: 10 weeks post-baselinePopulation: Numbers may differ due to missing data
This is the distance in feet that people walk over 6 minutes.
Outcome measures
| Measure |
Tailored Activity Pacing
n=50 Participants
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
n=50 Participants
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
n=60 Participants
Participants receiving usual care
|
|---|---|---|---|
|
Physical Function- Six Minute Walk
|
1200.5 feet
Standard Deviation 260.1
|
1249.4 feet
Standard Deviation 217.3
|
1236.1 feet
Standard Deviation 246.1
|
SECONDARY outcome
Timeframe: 6 months post baselinePopulation: Numbers may differ due to missing data
This is the distance people walk in feet over 6 minutes
Outcome measures
| Measure |
Tailored Activity Pacing
n=46 Participants
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
General Activity Pacing
n=46 Participants
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Usual Care Group
n=49 Participants
Participants receiving usual care
|
|---|---|---|---|
|
Physical Function- Six Minute Walk
|
1225.4 feet
Standard Deviation 240.1
|
1264.3 feet
Standard Deviation 192.9
|
1222.4 feet
Standard Deviation 265.6
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1
n=66 participants at risk
Tailored activity pacing
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
Arm 2
n=66 participants at risk
General activity pacing and symptom management
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
|
Arm 3
n=63 participants at risk
Usual care group
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
x-ray mistakes
|
4.5%
3/66 • Number of events 3 • Data were collected from baseline through completion of Time 3 outcome measures at 6 months
|
4.5%
3/66 • Number of events 3 • Data were collected from baseline through completion of Time 3 outcome measures at 6 months
|
1.6%
1/63 • Number of events 1 • Data were collected from baseline through completion of Time 3 outcome measures at 6 months
|
Additional Information
Research Health Science Specialist
Veterans Affairs--Ann Arbor Health Care System
Phone: 734-936-2123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place