University of Michigan at Detroit Departments of Rheumatology and Symptom Management July 22, 2004

1. STOP: Skills Training for Osteoarthritis PainAn RCT of a CBT-Based Self-Management Intervention for African-American Seniors with Osteoarthritis University of Michigan at Detroit Departments of Rheumatology and Symptom Management July 22, 2004

2. Study Investigators • John Samuels, MD, MPH – Principal Investigator • Joan Broderick, PhD – Co-Investigator • Ardith Doorenbos, RN, PhD – Co-Investigator • Kim Innes, MSPH, PhD – Co-Investigator • Shannon Jarrott, PhD – Co-Investigator • David Latini, PhD – Co-Investigator • Suzanne Lechner, PhD – Co-Investigator • Francis Keefe, PhD - Consultant • Patrick McGrath, PhD - Consultant • Michael Proschan, PhD – Statistical Consultant

3. Community Advisory Board • Joan Cook, RN, MSN, MPH – Senior Public Health Nurse, Detroit Department of Public Health • Rev. Jane Doe - Pastor, Detroit AME Church • Kathryn Kennedy, MSW – Director, Patient Education, Detroit Arthritis Foundation • Rev. John Smith – Pastor, Jones Methodist Church and Chair, Community Advisory Board • Ronald Williams – Director, Health & Environmental Resource Center

4. Background • One out of every 3 adults in the United States (70 million) is affected by arthritis. • Leading cause of disability - 18% of population • Medical costs for arthritis in 1995 were nearly $22 billion • When loss of productivity is added, the cost increased to $85 billion. • OA is the most prevalent type of arthritis. CDC

5. Background • Prevalence of arthritis higher in • women (37% vs. 28%), • older persons, • those with less education, and • white and African-American race. • Michigan is in the highest prevalence category (> 35%). • Rates highest among poor (36%) and less educated individuals (34%).

6. Background • 27% of adults with arthritis report limitation in activity • communication, • self-care • mobility • Learning • behavior • Significant disability, defined as the inability to perform two or more personal care activities higher among African-American (3.4%), Hispanic (3.5%), poor (5.4%), and less educated (3.4%).

7. Background • HRQOL consistently worse for persons with arthritis, • healthy days in the past 30 days, days without severe pain, • “ability days” (days without activity limitation), • difficulty in performing personal care activities. Healthy People 2010 • Healthy People 2010 Objective 2-1 • “Increase the mean number of days without severe pain among adults who have chronic joint symptoms.”

8. Background • African-Americans with OA less likely to seek joint replacement than whites. Dunlop et al, Med Care. 2003 Feb;41(2):288-98 • COX inhibitors • attenuate antihypertensive effects of ACE inhibitors • reduce kidney function • making non-pharmacologic means of controlling OA pain more desirable. Izhar et al, Hypertension. 2004 Mar;43(3):573-7

9. Pilot Work • Previous work by team with African-American elders shows • Recruiting procedures worked with this population • Advisory Committee useful in conceptualizing study • Cultural competence appropriate • Reading level of materials appropriate (< 6th grade) • Trend toward decreased observed pain behaviors

10. Study Hypotheses • A cognitive-behavioral treatment program for low SES African-American osteoarthritis patients 65 years of age or older will lead to significantly greater reductions in • Primary Outcome - Observed pain behavior • Secondary Outcomes - Self-reported pain on a visual analog scale and pain diary, disability (physical and psychological), activity level

11. Methods

12. African-American ≥ 65 years old Physician-confirmed diagnosis of osteoarthritis Willing to be randomized Household income less than 2x poverty level Able to speak, write, and understand English Able to participate in physical activity Usual pain ≥ 4 out of 10, 4 or more days per week over two months under usual care Pain impairs functional status Pain not better attributed to comorbid condition (e.g., HIV, diabetes, cancer, etc.) Cognitively intact Not on medications for psychosis and no more than 3 psychotropic medications No suicidal intent Inclusion Criteria

13. Physical therapist OA clinics/support groups Community mental health centers Community health centers/primary care Pharmacies/grocery stores Churches Beauty shops Barber shops Senior centers Arthritis Foundation or other CBO Home health agencies Nursing homes Bus advertising Meal programs Enrollment - Sources

14. Enrollment - Approaches • Advertising – newspaper, media coverage, newsletters, Flyers, coupon packs, radio • Talks – churches, senior centers • Alternative medicine practitioners • Endorsements by community leaders • Minority recruiters from the community • HIPAA-compliant

15. Cultural and linguistic considerations • Community-based organizations (CBO) • Established relationships with CBO serving African-Americans in Detroit • Community leaders helped formulate community approach • Community advisory board members will publicly endorse program and assist us in recruiting from their organizations. • Recruiting materials • Images and examples designed to appeal to African-Americans using guidelines developed by Guidry et al, 1996. • African-Americans are over-represented among persons with low health literacy {e.g., Bennett, JCO, 1998}. Materials will be written at the 6th grade reading level or below, with pictographs used where appropriate. • Teaching techniques for low literacy groups outlined by Doak & Doak will be used in the intervention (e..g, “teach-back”).

16. Procedures

17. Eligibility assessment • Screening phone call • Ascertain caller meets criteria (pain, age, ethnicity, income) • Screening visit • Rheumatologist examines potential participant (physical exam, medical history, X-ray, current meds)

18. Randomization Blocked randomization scheme • Recruit 20 people in a block • Randomize into two equal groups of 10 • Obtain randomization codes from outside lab • Randomly assign the 2 groups to condition to further avoid bias

19. Baseline assessment • Within 2 weeks of group start • Gathered during lab visit (paper-and-pencil measures, videotaped behavioral pain assessments, etc.) • Assessors blinded to treatment condition.

20. Follow-up assessment visits • Process measures after each group • Pain Behavior Observation Scale • Self-report measures • Assessors blinded to treatment condition

21. STOP: Intervention Format and Structure • Closed, structured group intervention (Keefe et al., 1990) • 10 consecutive 2.5-hours weekly sessions • 45-minute relaxation component, • 90-minute cognitive-behavioral stress management component, and • 15-minute break. • Groups of 8-10 participants and two co-therapists. • Therapists who administer the intervention will not assess participants • Multi-modal to enhance treatment efficacy (Powell, 2004) • Std care control with frequency contact

22. Issues and Techniques

23. Intervention Sessions

24. Intervention Fidelity Staff Training • Facilitators: Trained Master’s and Ph.D.-level clinical health psychologists • Each leader completes a 10-wk, 20-hour training seminar based on the Therapist Training Manual Adherence • Monitor cognitive restructuring skills acquisition • Assess adherence to take-home assignments • Observational assessment of relaxation skills • Participant diaries

25. Measures

26. Demographic Variables • age • education • Hollingshead Occupational Index (Hollingshead & Redlich, 1958) for socioeconomic status (SES) • religious affiliation • living situation • relationship status • Ethnic identity and cultural values (MEIM; Phinney, 1992)

27. Clinical/Medical Information • severity • date of diagnosis • treatments prescribed • Comorbidity (15-item Charlson Scale; Charlson et al., 1987) • total number of OTC substances, as well as other services obtained

28. Primary Outcome Measure Observed pain behavior (Keefe et al., 1990) • A standardized, videotaped observation protocol. Patients engage in 1- and 2-minute periods of sitting, walking, standing, and reclining. Treatment-blind observers code 5 pain behavior categories: • Guarding • Active rubbing of the knee • unloading of the joint • rigidity • joint flexing • Diary • Actigraph

29. Secondary Outcome Measures • End-of-day pain diary : Interactive Voice Recording (IVR) instrument will be used to collect daily ratings of pain levels on 10-point numerical scales. • Coping Strategies Questionnaire • Arthritis Self-Efficacy ScaleArthritis Impact Measurement Scale (AIMS) • Stress Management Skills-Measure of Current Status (MOCS) • Measure of physical activity level: 7-day actigraph

30. Process Measures • Group Relationship Questionnaire (Schneiderman, Antoni, & Ironson, 1985) • Profile of Mood States (POMS; McNair, Lorr, & Droppelman, 1971) • Group Climate Questionnaire (Schneiderman, Antoni, & Ironson, 1985) • Facilitator Debrief Measures • Facilitator Effectiveness Measures

31. Human Participants • IRB will approve protocol • Study staff have completed human subjects and HIPAA compliance training • DSMB will be established • Adverse events will be tracked • Additional contact time will be provided PRN

32. Analysis

33. Data Management • Data entered on scannable forms. Study staff scan forms daily and resolve discrepancies as needed. • Scanned data converted to SAS data sets and transmitted to study programmer electronically. • QA/QC reports run on each batch of data to check for out-of-range values, inconsistent values, etc. Errors resolved with data entry staff as needed. • Complete data files analyzed by study programmer under the direction of Dr. Proschan.

34. Sample Size and Power • Power analysis • For 2 group mixed model analysis • Account for possible effect of group membership • Using data from previous research, pilot study: • Assume SD of change of 4.6 • Observed values 3.2-4.6 (4.1 in pilot study) • Assume intraclass correlation coefficient of 0.2 • Observed value 0.16 (pilot study)

35. Sample Size and Power • To detect a change score difference of 2 points in observed pain behavior • At alpha =0.05 and Power=90% • Require total sample size of 400 • 200 treatment (20 groups of 10) • 200 controls

36. Analysis: Baseline variables • Descriptive statistics: baseline characteristics of treatment vs.control, attriters vs completers: • Demographics • OA characteristics • BMI, comorbidities, activity level • Differences assessed using: • Chi-square (categorical) • T-tests (continuous, normal distribution) • Mann-Whitney U test (ordinal, continuous with evidence of skewing) • Variables differing between tx and controls=> covariates in regression models

37. Primary Analysis • Intent to Treat • Mixed Model Linear Regression • Primary Outcome – Observed Pain Behavior • Random effect – group membership • Fixed effects- • Primary predictor: Treatment • Covariates: Age, gender, other • Missing data: Sensitivity analysis using multiple imputation methods (Little & Rubin, 2001)

38. Secondary Analyses • Separate mixed model analyses • Evaluate effect of intervention (tx) on change from baseline in: • Observed pain behavior at 3 mo. post-tx follow-up • Avg. self-reported pain (pain diary):10 weeks; 3 mo. post-tx follow-up • AIMS score-pain: 10 weeks and 3 mo. post-tx follow-up • AIMS score-psychological disability: 10 weeks and 3 mo. post-tx follow-up • AIMS score-physical disability: 10 weeks and 3 mo. post-tx follow-up • Average activity level (actigraphy):10 weeks and 3 mo. post-tx follow-up • Fixed effects: Tx, covariates • Random effect: Group

39. Thanks for your attention Grant award notices gladly accepted

40. Health Behaviors • Alcohol Use Interview (Warheit, 1987) • 7-item dietary measure (Thompson et al., 1999). • Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) • CHAMPS survey of physical activity (Stewart et al., 2001)