Arthritis
Conditions
Keywords
Health Status Disparities, Arthritis, Psychology, Pain Management, Affect
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.
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.
Interventions
BEHAVIORALPositive 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.
BEHAVIORALAttention 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The statistician will seal PA and AC program workbooks in envelopes following the randomization scheme. To blind participants and staff during the baseline assessment, staff will take the next sealed envelope in the sequence to each baseline visit, to be opened after a patient has consented and completed the baseline assessment. The study staff that complete the baseline visits will be unblinded once a participant's envelope is opened; participants will not be told whether they are in the PA or AC program. Staff who conduct the weekly intervention calls in the 6 weeks following the baseline visit will also be unblinded. To maintain blinding for the collection of outcome measures, study staff members who did not complete the baseline visit or any weekly calls during the 6-week program period for a given participant will collect the 1, 3, and 6-month follow-up assessments.
Intervention model description
Randomization will be at the patient level, stratified by study site and patient race, with a 1:1 allocation using random block sizes of 2, 4, 6, or 8.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 180 |
| 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. | 180 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 6 | 11 |
| Overall Study | Refused | 9 | 9 |
| Overall Study | Withdrawal by Subject | 8 | 5 |
Baseline characteristics
| Characteristic | Positive Activities (PA) | Total | Attention Control (AC) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 85 Participants | 165 Participants | 80 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants | 195 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 180 Participants | 360 Participants | 180 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 90 Participants | 180 Participants | 90 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 90 Participants | 180 Participants | 90 Participants |
| Region of Enrollment United States | 180 Participants | 360 Participants | 180 Participants |
| 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 | 5.01 units on a scale STANDARD_DEVIATION 2.06 | 4.89 units on a scale STANDARD_DEVIATION 1.96 |
| 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 | 48.83 units on a scale STANDARD_DEVIATION 17.55 | 47.42 units on a scale STANDARD_DEVIATION 18.07 |
| 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 | 46.82 units on a scale STANDARD_DEVIATION 18.14 | 45.70 units on a scale STANDARD_DEVIATION 18.53 |
| Sex: Female, Male Female | 44 Participants | 85 Participants | 41 Participants |
| Sex: Female, Male Male | 136 Participants | 275 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 180 | 1 / 180 |
| other Total, other adverse events | 0 / 180 | 0 / 180 |
| serious Total, serious adverse events | 12 / 180 | 8 / 180 |
Outcome results
Primary
Self-reported Pain From Baseline to 1, 3, and 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.
Time frame: Baseline to 6 months post-intervention
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Activities (PA) | Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention | Baseline | 50.24 units on a scale | Standard Deviation 16.95 |
| Positive Activities (PA) | 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 |
| Positive Activities (PA) | 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 |
| Positive Activities (PA) | 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 |
| Attention Control (AC) | Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention | 6 month | 41.59 units on a scale | Standard Deviation 19.87 |
| Attention Control (AC) | Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention | Baseline | 47.42 units on a scale | Standard Deviation 18.07 |
| Attention Control (AC) | Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention | 3 month | 43.32 units on a scale | Standard Deviation 19.13 |
| Attention Control (AC) | Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention | 1 month | 43.57 units on a scale | Standard Deviation 20.93 |
p-value: 0.791Mixed Models Analysis
Primary
Self-reported Physical Functioning From Baseline to 1, 3, and 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.
Time frame: Baseline to 6 months post-intervention
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Activities (PA) | 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 |
| Positive Activities (PA) | 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 |
| Positive Activities (PA) | 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 |
| Positive Activities (PA) | 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 |
| Attention Control (AC) | Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention | 6 month | 41.91 units on a scale | Standard Deviation 20 |
| Attention Control (AC) | Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention | Baseline | 45.70 units on a scale | Standard Deviation 18.53 |
| Attention Control (AC) | Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention | 3 month | 43.32 units on a scale | Standard Deviation 19.8 |
| Attention Control (AC) | Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention | 1 month | 43.08 units on a scale | Standard Deviation 20.97 |
p-value: 0.88Mixed Models Analysis
Other Pre-specified
Patient Global Assessment of Pain From Baseline to 1, 3, and 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.
Time frame: Baseline to 6 months post-intervention
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Activities (PA) | 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 |
| Positive Activities (PA) | 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 |
| Positive Activities (PA) | 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 2.1 |
| Positive Activities (PA) | 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 |
| Attention Control (AC) | Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention | 6 month | 4.60 units on a scale | Standard Deviation 2.24 |
| Attention Control (AC) | Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention | 1 month | 4.71 units on a scale | Standard Deviation 2.21 |
| Attention Control (AC) | Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention | 3 month | 4.69 units on a scale | Standard Deviation 2.06 |
| Attention Control (AC) | Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention | Baseline | 4.89 units on a scale | Standard Deviation 1.96 |
p-value: 0.901Mixed Models Analysis