Staying Positive With Arthritis Study

NCT02223858 | Completed Results

• 1 other identifier: IIR 13-080
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthritis

Keywords

Health Status Disparities; Arthritis; Psychology; Pain Management; Affect

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to 6 months post-intervention

• 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.

  Baseline to 6 months post-intervention

Other Outcomes (1)

• Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention

  Baseline to 6 months post-intervention

Study Arms (2)

Positive Activities (PA)

EXPERIMENTAL

Positive Activities (PA) Program

Behavioral: Positive Activities (PA) Program

Attention Control (AC)

ACTIVE COMPARATOR

Attention Control (AC) Program

Behavioral: Attention Control (AC) Program

Interventions

Positive Activities (PA) Program BEHAVIORAL

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.

Positive Activities (PA)

Attention Control (AC) Program BEHAVIORAL

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.

Attention Control (AC)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (5)

• 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.

  PMID: 28893676 BACKGROUND

• 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.

  PMID: 29044408 BACKGROUND

• Vina ER, Hausmann LRM, Obrosky DS, Youk A, Ibrahim SA, Weiner DK, Gallagher RM, Kwoh CK. Social & psychological factors associated with oral analgesic use in knee osteoarthritis management. Osteoarthritis Cartilage. 2019 Jul;27(7):1018-1025. doi: 10.1016/j.joca.2019.01.010. Epub 2019 Feb 1.

  PMID: 30716537 RESULT

• McClendon J, Essien UR, Youk A, Ibrahim SA, Vina E, Kwoh CK, Hausmann LRM. Cumulative Disadvantage and Disparities in Depression and Pain Among Veterans With Osteoarthritis: The Role of Perceived Discrimination. Arthritis Care Res (Hoboken). 2021 Jan;73(1):11-17. doi: 10.1002/acr.24481.

  PMID: 33026710 DERIVED

• Hausmann LRM, Youk A, Kwoh CK, Gallagher RM, Weiner DK, Vina ER, Obrosky DS, Mauro GT, McInnes S, Ibrahim SA. Effect of a Positive Psychological Intervention on Pain and Functional Difficulty Among Adults With Osteoarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e182533. doi: 10.1001/jamanetworkopen.2018.2533.

  PMID: 30646170 DERIVED

MeSH Terms

Conditions

Arthritis; Agnosia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Included patients with knee osteoarthritis from 2 VA medical centers; did not assess pain conditions other than arthritis; adherence and outcomes were self-reported.

Results Point of Contact

• Title: Dr. Leslie R.M. Hausmann
• Organization: Veterans Affairs Pittsburgh Healthcare System

leslie.hausmann@va.gov

412-360-2112

Study Officials

• Leslie RM Hausmann, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 22, 2014
• Study Start: July 13, 2015
• Primary Completion: November 9, 2017
• Study Completion: November 9, 2017
• Last Updated: April 3, 2019
• Results First Posted: February 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)