SPA: Staying Positive With Arthritis Study
Study Details
Study Description
Brief Summary
Arthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield only small to moderate improvements in pain and are not effective at reducing racial disparities in arthritis pain. According to the biopsychosocial model of pain, there is a need for novel interventions that target psychosocial factors associated with arthritis outcomes and disparities in outcomes. Evidence from the field of psychology suggests that an intervention designed to develop a positive mindset has the potential to improve pain and functioning and reduce racial disparities in patients with arthritis. Interventions to foster a positive mindset have been developed for clinical patient populations but have not yet been fully tested in patients with arthritis or in Veterans, nor have their effects on racial differences in clinical outcomes been examined. This study will address these gaps by testing the impact of an evidence-based positive activities intervention on pain and functioning in African American and White Veterans with knee arthritis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Background: Arthritis is a prevalent and disabling source of chronic pain for which African Americans (AAs) bear a disproportionate burden. The purpose of this study is to test a patient-centered, non-invasive intervention to improve pain outcomes and reduce disparities in AA and White Veterans with knee arthritis. The intervention is designed to help Veterans develop a positive mindset, the health benefits of which are well-documented.
Objectives: The primary aim of this study is to evaluate the impact of a positive intervention on pain and physical functioning in AA and White Veterans with knee arthritis through a randomized, controlled, clinical trial. It is hypothesized that patients randomized to a positive activities (PA) intervention will experience improved pain and functioning compared to patients randomized to an attention control (AC) program, and that these improvements will be larger for AA than for WH Veterans. The secondary aim of this study is to identify variables that mediate the effects of the PA intervention on pain and functioning. It is hypothesized that the effects of the PA intervention will be mediated by psychosocial variables known to be associated with arthritis outcomes or racial differences in arthritis outcomes (e.g., depression, self-efficacy, pain coping, perceived discrimination).
Methods: A randomized, controlled, 2-arm design will be used to compare the effects of a 6-week PA intervention with that of an AC program on pain and functioning at 1, 3, and 6-months post-intervention among AA and WH Veterans with knee arthritis. Approximately 180 AA and 180 WH primary care patients with knee pain symptoms consistent with arthritis will be recruited from participating VA medical centers following the original protocol. [Due to accelerated recruitment of the original target sample, up to 240 additional primary care patients with knee pain symptoms consistent with OA will be recruited from participating VA medical centers using inclusion criteria that take into account original ICD-9 codes and their corresponding ICD-10 codes. The additional patients (including some men and some women, as resources allow) will be recruited to increase power to detect sex differences in secondary analyses after the primary aims of the study have been achieved using the original cohort.] Eligible participants will complete an in-person baseline assessment of study outcomes, mediators, and control variables and be randomized to a 6-week PA or AC program. The PA program consists of completing 6 at-home activities (1 per week) that have been shown to increase positivity. The AC program consists of 6 affectively neutral activities. Both groups will receive weekly telephone calls from trained interventionists to clarify instructions for the next week's activity and assess completion of the previous week's activity. Outcomes and proposed mediating variables will be assessed via telephone surveys at 1 month, 3 months, and 6 months post-intervention. Study outcomes include self-reported pain and physical functioning as measured by the Western Ontario MacMaster Index. Hypothesized mediators include depressive symptoms, positive/negative affect, satisfaction with life, arthritis self-efficacy, pain coping, pain catastrophizing, perceived discrimination, global stress, and social support. The intervention impact over time and by race (primary aim) will be tested using linear mixed models that allow repeated measures on the continuous outcomes for each participant and assess change in outcomes over time. A multiple mediator bootstrap approach to assess whether the effect of the intervention is mediated by the hypothesized mediators.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Positive Activities (PA) Positive Activities (PA) Program |
Behavioral: Positive Activities (PA) Program
6-week program of at-home activities (1 per week) that have been shown to increase positivity. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.
|
| Active Comparator: Attention Control (AC) Attention Control (AC) Program |
Behavioral: Attention Control (AC) Program
6-week program of at-home activities (1 per week) based on affectively neutral activities from control conditions in studies of positive activities interventions. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.
|
Outcome Measures
Primary Outcome Measures
- Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention [Baseline to 6 months post-intervention]
Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.
- Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention [Baseline to 6 months post-intervention]
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.
Other Outcome Measures
- Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention [Baseline to 6 months post-intervention]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
The target population will be African American (AA) and White (WH) Veterans with symptomatic knee arthritis. Specific inclusion criteria include:
-
Age 50 years or older
-
Receive primary care at a participating study site
-
Self-report as non-Hispanic black/AA or non-Hispanic WH
-
Frequent, symptomatic knee pain identified using questions from the OA Initiative
-
Pain level of 4 or higher on a 0-10 numeric rating scale
-
Can speak, read, and write in English
Exclusion Criteria:
Patients will be excluded if they:
-
Report serious problems with hearing, eyesight, or memory
-
Report having been diagnosed any type of arthritis other than osteoarthritis or degenerative arthritis
-
Report that they have been treated for cancer in the last 3 years
-
Report having had a steroid injection into one or both knees in the past 3 months
-
Report having had a knee replacement into one or both knees in the past 3 months
-
Report having plans to have a knee replacement in one or both knees in the next 6 months
-
Report that there is a reason they cannot complete the study procedures, which include telephone calls and program activities that involve reading and writing
-
Do not have a telephone number where they can receive telephone calls from research staff
-
Screen positive for cognitive impairment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | United States | 19104 |
| 2 | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | United States | 15240 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Leslie RM Hausmann, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Study Documents (Full-Text)
More Information
Publications
- Hausmann LRM, Ibrahim SA, Kwoh CK, Youk A, Obrosky DS, Weiner DK, Vina E, Gallagher RM, Mauro GT, Parks A. Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain. Contemp Clin Trials. 2018 Jan;64:243-253. doi: 10.1016/j.cct.2017.09.001. Epub 2017 Sep 8.
- Hausmann LRM, Youk A, Kwoh CK, Ibrahim SA, Hannon MJ, Weiner DK, Gallagher RM, Parks A. Testing a Positive Psychological Intervention for Osteoarthritis. Pain Med. 2017 Oct 1;18(10):1908-1920. doi: 10.1093/pm/pnx141. Erratum in: Pain Med. 2017 Sep 1;18(9):1830.
- IIR 13-080
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Positive Activities (PA) | Attention Control (AC) |
|---|---|---|
| Arm/Group Description | 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) 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. |
| Period Title: Overall Study | ||
| STARTED | 180 | 180 |
| 1-month Follow-up | 156 | 150 |
| 3-month Follow-up | 155 | 154 |
| 6-month Follow-up | 156 | 154 |
| COMPLETED | 156 | 154 |
| NOT COMPLETED | 24 | 26 |
Baseline Characteristics
| Arm/Group Title | Positive Activities (PA) | Attention Control (AC) | Total |
|---|---|---|---|
| Arm/Group Description | 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) 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 of all reporting groups |
| Overall Participants | 180 | 180 | 360 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
95
52.8%
|
100
55.6%
|
195
54.2%
|
| >=65 years |
85
47.2%
|
80
44.4%
|
165
45.8%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
44
24.4%
|
41
22.8%
|
85
23.6%
|
| Male |
136
75.6%
|
139
77.2%
|
275
76.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
180
100%
|
180
100%
|
360
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
90
50%
|
90
50%
|
180
50%
|
| White |
90
50%
|
90
50%
|
180
50%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
180
100%
|
180
100%
|
360
100%
|
| Self-reported pain, physical functioning, and global assessment of pain at baseline (units on a scale) [Mean (Standard Deviation) ] | |||
| Pain (Western Ontario McMaster Index;100=worst)* |
50.24
(16.95)
|
47.42
(18.07)
|
48.83
(17.55)
|
| Physical functioning (WOMAC; 100=worst)* |
47.94
(17.73)
|
45.70
(18.53)
|
46.82
(18.14)
|
| Global assessment (0-10; higher=worse)* |
5.13
(2.14)
|
4.89
(1.96)
|
5.01
(2.06)
|
Outcome Measures
| Title | Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention |
|---|---|
| Description | Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain. |
| Time Frame | Baseline to 6 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Positive Activities (PA) | Attention Control (AC) |
|---|---|---|
| Arm/Group Description | 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) 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. |
| Measure Participants | 180 | 180 |
| Baseline |
50.24
(16.95)
|
47.42
(18.07)
|
| 1 month |
45.42
(18.58)
|
43.57
(20.93)
|
| 3 month |
43.87
(19.16)
|
43.32
(19.13)
|
| 6 month |
43.22
(20.97)
|
41.59
(19.87)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Positive Activities (PA), Attention Control (AC) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | A sample size of 360 patients (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power. | |
| Statistical Test of Hypothesis | p-Value | 0.791 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | All models adjusted for site. | |
| Title | Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 6 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Positive Activities (PA) | Attention Control (AC) |
|---|---|---|
| Arm/Group Description | 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) 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. |
| Measure Participants | 180 | 180 |
| Baseline |
47.94
(17.73)
|
45.70
(18.53)
|
| 1 month |
44.61
(19.81)
|
43.08
(20.97)
|
| 3 month |
43.39
(19.01)
|
43.32
(19.80)
|
| 6 month |
43.89
(20.02)
|
41.91
(20.00)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Positive Activities (PA), Attention Control (AC) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power. | |
| Statistical Test of Hypothesis | p-Value | 0.880 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | All models adjusted for site. | |
| Title | Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 6 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Positive Activities (PA) | Attention Control (AC) |
|---|---|---|
| Arm/Group Description | 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) 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. |
| Measure Participants | 180 | 180 |
| Baseline |
5.13
(2.14)
|
4.89
(1.96)
|
| 1 month |
4.77
(2.16)
|
4.71
(2.21)
|
| 3 month |
4.83
(2.10)
|
4.69
(2.06)
|
| 6 month |
4.82
(2.27)
|
4.60
(2.24)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Positive Activities (PA), Attention Control (AC) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscale, and a 80% power. | |
| Statistical Test of Hypothesis | p-Value | 0.901 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | All models adjusted for site. | |
Adverse Events
| Time Frame | From baseline through 6-months post intervention. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Positive Activities (PA) | Attention Control (AC) | ||
| Arm/Group Description | 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) 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. | ||
All Cause Mortality |
||||
| Positive Activities (PA) | Attention Control (AC) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/180 (0.6%) | 1/180 (0.6%) | ||
Serious Adverse Events |
||||
| Positive Activities (PA) | Attention Control (AC) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/180 (6.7%) | 8/180 (4.4%) | ||
| Cardiac disorders | ||||
| Hospitalizations unrelated to the study | 3/180 (1.7%) | 3 | 2/180 (1.1%) | 2 |
| Endocrine disorders | ||||
| Hospitalizations unrelated to the study | 0/180 (0%) | 0 | 1/180 (0.6%) | 1 |
| Gastrointestinal disorders | ||||
| Hospitalizations unrelated to the study | 3/180 (1.7%) | 3 | 0/180 (0%) | 0 |
| General disorders | ||||
| Hospitalizations unrelated to the study | 4/180 (2.2%) | 4 | 1/180 (0.6%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Hospitalizations unrelated to the study | 0/180 (0%) | 0 | 1/180 (0.6%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Hospitalizations unrelated to the study | 1/180 (0.6%) | 1 | 0/180 (0%) | 0 |
| Psychiatric disorders | ||||
| Hospitalizations unrelated to the study | 0/180 (0%) | 0 | 1/180 (0.6%) | 1 |
| Renal and urinary disorders | ||||
| Hospitalizations unrelated to the study | 0/180 (0%) | 0 | 1/180 (0.6%) | 1 |
| Surgical and medical procedures | ||||
| Hospitalizations unrelated to the study | 0/180 (0%) | 0 | 1/180 (0.6%) | 1 |
| Vascular disorders | ||||
| Hospitalizations unrelated to the study | 1/180 (0.6%) | 1 | 0/180 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Positive Activities (PA) | Attention Control (AC) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/180 (0%) | 0/180 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Leslie R.M. Hausmann |
|---|---|
| Organization | Veterans Affairs Pittsburgh Healthcare System |
| Phone | 412-360-2112 |
| leslie.hausmann@va.gov |
- IIR 13-080