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Staying Positive With Arthritis Study (SPA)

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ClinicalTrials.gov Identifier: NCT02223858
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : February 11, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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
Arthritis Behavioral: Positive Activities (PA) Program Behavioral: Attention Control (AC) Program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: Double (Participant, 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.
Primary Purpose: Health Services Research
Official Title: Staying Positive: An Intervention to Reduce Osteoarthritis Pain Disparities
Actual Study Start Date : July 13, 2015
Actual Primary Completion Date : November 9, 2017
Actual Study Completion Date : November 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

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.




Primary Outcome Measures :
  1. Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention [ Time Frame: 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.

  2. Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention [ Time Frame: 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:
  1. Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223858


Locations
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United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Leslie RM Hausmann, PhD VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Informed Consent Form  [PDF] May 18, 2016


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02223858     History of Changes
Other Study ID Numbers: IIR 13-080
First Posted: August 22, 2014    Key Record Dates
Results First Posted: February 11, 2019
Last Update Posted: April 3, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Health Status Disparities
Arthritis
Psychology
Pain Management
Affect

Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases