Trial Outcomes & Findings for Staying Positive With Arthritis Study (NCT NCT02223858)
NCT ID: NCT02223858
Last Updated: 2019-04-03
Results Overview
Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.
COMPLETED
NA
360 participants
Baseline to 6 months post-intervention
2019-04-03
Participant Flow
Patients with symptomatic knee OA from Veterans Affairs (VA) medical centers in Pittsburgh and Philadelphia, Pennsylvania, were recruited by mail and telephone. Mailings were sent to patients meeting basic eligibility criteria based on their VA medical records Recruitment for the study ran from July 2015 to February 2017.
Eligible patients attended an in-person baseline visit where they provided written informed consent, completed a staff-administered baseline assessment, and were randomized to a 6-week positive psychological intervention or neutral control program.
Participant milestones
| Measure |
Positive Activities (PA)
Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
|
Attention Control (AC)
Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
180
|
|
Overall Study
1-month Follow-up
|
156
|
150
|
|
Overall Study
3-month Follow-up
|
155
|
154
|
|
Overall Study
6-month Follow-up
|
156
|
154
|
|
Overall Study
COMPLETED
|
156
|
154
|
|
Overall Study
NOT COMPLETED
|
24
|
26
|
Reasons for withdrawal
| Measure |
Positive Activities (PA)
Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
|
Attention Control (AC)
Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
11
|
|
Overall Study
Withdrawal by Subject
|
8
|
5
|
|
Overall Study
Refused
|
9
|
9
|
Baseline Characteristics
For Pain and Physical Functioning, those who skipped \>20% of items within a scale (\>1 or \>3 items, respectively) were excluded. \*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).
Baseline characteristics by cohort
| Measure |
Positive Activities (PA)
n=180 Participants
Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
|
Attention Control (AC)
n=180 Participants
Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=180 Participants
|
100 Participants
n=180 Participants
|
195 Participants
n=360 Participants
|
|
Age, Categorical
>=65 years
|
85 Participants
n=180 Participants
|
80 Participants
n=180 Participants
|
165 Participants
n=360 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=180 Participants
|
41 Participants
n=180 Participants
|
85 Participants
n=360 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=180 Participants
|
139 Participants
n=180 Participants
|
275 Participants
n=360 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
180 Participants
n=180 Participants
|
180 Participants
n=180 Participants
|
360 Participants
n=360 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Race (NIH/OMB)
Black or African American
|
90 Participants
n=180 Participants
|
90 Participants
n=180 Participants
|
180 Participants
n=360 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=180 Participants
|
90 Participants
n=180 Participants
|
180 Participants
n=360 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Region of Enrollment
United States
|
180 Participants
n=180 Participants
|
180 Participants
n=180 Participants
|
360 Participants
n=360 Participants
|
|
Self-reported pain, physical functioning, and global assessment of pain at baseline
Pain (Western Ontario McMaster Index;100=worst)*
|
50.24 units on a scale
STANDARD_DEVIATION 16.95 • n=179 Participants • For Pain and Physical Functioning, those who skipped \>20% of items within a scale (\>1 or \>3 items, respectively) were excluded. \*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).
|
47.42 units on a scale
STANDARD_DEVIATION 18.07 • n=178 Participants • For Pain and Physical Functioning, those who skipped \>20% of items within a scale (\>1 or \>3 items, respectively) were excluded. \*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).
|
48.83 units on a scale
STANDARD_DEVIATION 17.55 • n=357 Participants • For Pain and Physical Functioning, those who skipped \>20% of items within a scale (\>1 or \>3 items, respectively) were excluded. \*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).
|
|
Self-reported pain, physical functioning, and global assessment of pain at baseline
Physical functioning (WOMAC; 100=worst)*
|
47.94 units on a scale
STANDARD_DEVIATION 17.73 • n=177 Participants • For Pain and Physical Functioning, those who skipped \>20% of items within a scale (\>1 or \>3 items, respectively) were excluded. \*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).
|
45.70 units on a scale
STANDARD_DEVIATION 18.53 • n=174 Participants • For Pain and Physical Functioning, those who skipped \>20% of items within a scale (\>1 or \>3 items, respectively) were excluded. \*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).
|
46.82 units on a scale
STANDARD_DEVIATION 18.14 • n=351 Participants • For Pain and Physical Functioning, those who skipped \>20% of items within a scale (\>1 or \>3 items, respectively) were excluded. \*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).
|
|
Self-reported pain, physical functioning, and global assessment of pain at baseline
Global assessment (0-10; higher=worse)*
|
5.13 units on a scale
STANDARD_DEVIATION 2.14 • n=180 Participants • For Pain and Physical Functioning, those who skipped \>20% of items within a scale (\>1 or \>3 items, respectively) were excluded. \*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).
|
4.89 units on a scale
STANDARD_DEVIATION 1.96 • n=180 Participants • For Pain and Physical Functioning, those who skipped \>20% of items within a scale (\>1 or \>3 items, respectively) were excluded. \*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).
|
5.01 units on a scale
STANDARD_DEVIATION 2.06 • n=360 Participants • For Pain and Physical Functioning, those who skipped \>20% of items within a scale (\>1 or \>3 items, respectively) were excluded. \*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).
|
PRIMARY outcome
Timeframe: Baseline to 6 months post-interventionPopulation: Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs overall number analyzed.
Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.
Outcome measures
| Measure |
Positive Activities (PA)
n=180 Participants
Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
|
Attention Control (AC)
n=180 Participants
Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
|
|---|---|---|
|
Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention
Baseline
|
50.24 units on a scale
Standard Deviation 16.95
|
47.42 units on a scale
Standard Deviation 18.07
|
|
Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention
1 month
|
45.42 units on a scale
Standard Deviation 18.58
|
43.57 units on a scale
Standard Deviation 20.93
|
|
Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention
3 month
|
43.87 units on a scale
Standard Deviation 19.16
|
43.32 units on a scale
Standard Deviation 19.13
|
|
Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention
6 month
|
43.22 units on a scale
Standard Deviation 20.97
|
41.59 units on a scale
Standard Deviation 19.87
|
PRIMARY outcome
Timeframe: Baseline to 6 months post-interventionPopulation: Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs overall number analyzed.
Difficulty with physical functioning subscale of the Western Ontario McMaster (WOMAC) Index. Physical functioning is on a scale of 0-100; higher scores mean worse physical functioning.
Outcome measures
| Measure |
Positive Activities (PA)
n=180 Participants
Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
|
Attention Control (AC)
n=180 Participants
Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
|
|---|---|---|
|
Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention
Baseline
|
47.94 units on a scale
Standard Deviation 17.73
|
45.70 units on a scale
Standard Deviation 18.53
|
|
Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention
1 month
|
44.61 units on a scale
Standard Deviation 19.81
|
43.08 units on a scale
Standard Deviation 20.97
|
|
Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention
3 month
|
43.39 units on a scale
Standard Deviation 19.01
|
43.32 units on a scale
Standard Deviation 19.80
|
|
Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention
6 month
|
43.89 units on a scale
Standard Deviation 20.02
|
41.91 units on a scale
Standard Deviation 20.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6 months post-interventionPopulation: Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs from the overall number analyzed.
Self-reported global assessment of pain in the last week using a numeric rating scale. Global assessment of pain is on a scale of 0-10; higher scores mean worse pain.
Outcome measures
| Measure |
Positive Activities (PA)
n=180 Participants
Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
|
Attention Control (AC)
n=180 Participants
Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
|
|---|---|---|
|
Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention
Baseline
|
5.13 units on a scale
Standard Deviation 2.14
|
4.89 units on a scale
Standard Deviation 1.96
|
|
Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention
1 month
|
4.77 units on a scale
Standard Deviation 2.16
|
4.71 units on a scale
Standard Deviation 2.21
|
|
Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention
3 month
|
4.83 units on a scale
Standard Deviation 2.10
|
4.69 units on a scale
Standard Deviation 2.06
|
|
Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention
6 month
|
4.82 units on a scale
Standard Deviation 2.27
|
4.60 units on a scale
Standard Deviation 2.24
|
Adverse Events
Positive Activities (PA)
Attention Control (AC)
Serious adverse events
| Measure |
Positive Activities (PA)
n=180 participants at risk
Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
|
Attention Control (AC)
n=180 participants at risk
Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
|
|---|---|---|
|
General disorders
Hospitalizations unrelated to the study
|
2.2%
4/180 • Number of events 4 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
0.56%
1/180 • Number of events 1 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalizations unrelated to the study
|
0.56%
1/180 • Number of events 1 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
0.00%
0/180 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
|
Cardiac disorders
Hospitalizations unrelated to the study
|
1.7%
3/180 • Number of events 3 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
1.1%
2/180 • Number of events 2 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
|
Gastrointestinal disorders
Hospitalizations unrelated to the study
|
1.7%
3/180 • Number of events 3 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
0.00%
0/180 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
|
Psychiatric disorders
Hospitalizations unrelated to the study
|
0.00%
0/180 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
0.56%
1/180 • Number of events 1 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
|
Renal and urinary disorders
Hospitalizations unrelated to the study
|
0.00%
0/180 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
0.56%
1/180 • Number of events 1 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
|
Vascular disorders
Hospitalizations unrelated to the study
|
0.56%
1/180 • Number of events 1 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
0.00%
0/180 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
|
Endocrine disorders
Hospitalizations unrelated to the study
|
0.00%
0/180 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
0.56%
1/180 • Number of events 1 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
|
Injury, poisoning and procedural complications
Hospitalizations unrelated to the study
|
0.00%
0/180 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
0.56%
1/180 • Number of events 1 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
|
Surgical and medical procedures
Hospitalizations unrelated to the study
|
0.00%
0/180 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
0.56%
1/180 • Number of events 1 • From baseline through 6-months post intervention.
All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Leslie R.M. Hausmann
Veterans Affairs Pittsburgh Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place