Improving Motivation for Physical Activity in Arthritis Clinical Trial
Improving Motivation for Physical Activity in Arthritis Clinical Trial
Arthritis is a major cause of disability. Of the nearly 70 million persons in the US with
 arthritis and/or chronic joint symptoms, nearly 8 million are disabled because of their
 arthritis. Knee osteoarthritis (OA) and rheumatoid arthritis (RA) are two of its most common
 and disabling forms. Despite evidence that physical activity can improve functional and
 health related quality of life (HRQOL) outcomes and lower health care costs, the proportion
 of the US population engaging in the recommended amount of physical activity is low and even
 lower among those with arthritis. Moreover, there is considerable variation in clinicians'
 promotion of physical activity for arthritis clients. Care providers infrequently ask clients
 about their physical activity behavior and report feeling unprepared to promote physical
 activity.

 This application studies the effects of a behavioral intervention aimed at promoting physical
 activity, including lifestyle physical activity, on arthritis-specific and generic HRQOL
 outcomes. The proposed physical activity management program (PAM) is based on a chronic care
 model in which allied health professionals promote patient self-management activities outside
 of traditional physician office encounters. The program is an individualized counseling and
 referral intervention, conducted by physical activity managers, directed by a theory-based
 comprehensive assessment of individual patient barriers and strengths related to physical
 activity performance. The specific aims of this randomized, controlled trial of 480 clients
 with RA and knee OA followed for 24 months are to test the effectiveness of physical activity
 management combined with physician physical activity promotion (PAM group) compared to
 physician physical activity promotion only (control group) in improving arthritis-specific
 and generic HRQOL, observed measures of function, and objectively measured and self-reported
 physical activity levels. In addition, exploratory analyses will be done to assess whether
 the improvements in HRQOL and physical activity performance associated with the PAM program
 are mediated by increases in physical activity levels and theory-based motivational
 variables, respectively. This study is intended to generate feasible methods by which health
 care providers and health care systems can increase physical activity levels in clients with
 arthritis and to result in widely applicable strategies for health behavior change.
Research Design Overview This five-year study is a randomized controlled trial of 480 clients
 with arthritis conducted at three sites on the Northwestern University Feinberg School of
 Medicine campus, the Rehabilitation Institute of Chicago Arthritis Center (RIC-AC), the
 Northwestern Medical Faculty Foundation Rheumatology Division Ambulatory Center (NMFF-Rheum),
 and the NMFF General Internal Medicine Ambulatory Center (NMFF-GIM). After a 6 month startup
 period, two hundred forty clients with RA (120 from RIC-AC and 120 from NMFF-Rheum) and 240
 clients with knee OA (120 from RIC-AC, 60 from NMFF-Rheum, and 60 from NMFF-GIM) will be
 recruited over a 24 month period, and each subject will be followed for 24 months.
 Randomization will be stratified by diagnosis, site, and disease-specific physical functional
 status. Half the clients will be randomized to the PAM intervention and half to the control
 intervention.

 Independent variables include demographic characteristics, arthritis severity and comorbid
 conditions, and other IMCHB model variables: motivation (self-regulation efficacy), cognitive
 appraisal (perceived competency), and affective response (mental health). Outcomes measured
 by blinded interviewers/assessors include self-reported and objective measures of physical
 activity, self-reported measures of disease specific and generic health-related quality of
 life, and observed measures of physical function. All independent variables and outcomes are
 measured at baseline and nearly all independent variables and all outcomes are measured at 3,
 6, 12, 18, and 24 months of follow-up. The primary analysis tests the effectiveness of PAM
 compared to control groups in improving disease-specific health related quality of life
 (HRQOL). Secondary analyses test 1) the effectiveness of PAM compared to control groups in
 improving generic HRQOL, 2) the effectiveness of PAM compared to control groups in improving
 observed measures of function and cardiovascular fitness, 3) the effectiveness of PAM
 compared to control groups in increasing physical activity performance, 4) whether PAM's
 effectiveness in improving HRQOL is mediated by it's ability to increase physical activity
 and 5) whether PAM's effectiveness in improving physical activity performance is mediated by
 changes in theory-based motivation variables.

 Description and justification of the study population Given that there are more than 100
 different forms of arthritis (defined here as any chronic condition affecting the joints and
 surrounding tissues), we have chosen clients with two well-defined and pathophysiologically
 distinct diseases to study, knee osteoarthritis (OA) and rheumatoid arthritis (RA). Knee OA
 is a prototype of a chronic degenerative arthropathy that has a high prevalence and is
 associated with a great amount of disability. RA is a prototype of the most common chronic
 inflammatory arthropathy, again associated with a high rate of disability. We expect that if
 the PAM program is effective in improving the physical activity and health status levels of
 these two distinctly different groups of arthritis clients, then it should be effective for
 many other, if not all, other arthritis clients.

 Case definitions. Classification criteria developed by the American College of Rheumatology
 (ACR) will be used for clients with both knee OA and RA. The criteria utilizing knee x-rays
 will be used to increase the specificity of the knee OA criteria. These are standard case
 definitions that are used routinely in the rheumatology literature and have been shown to
 have high sensitivity and specificity.108, 109 Selection criteria. Clients fulfilling the ACR
 criteria for knee OA or RA will be eligible for this trial if the meet the following
 criteria: 1) age 18 or older, 2) able to ambulate at least household distances (50ft), and 3)
 able to speak and understand English, 4) no plans for total joint replacement in the
 following 12 months, 5) no contraindication to physical activity due to a comorbid
 conditions, and 6) no plans to relocate away from the Chicago land area for at least 24
 months.

 Methods for recruiting, enrolling, and sustaining participation. The Rehabilitation Institute
 of Chicago Arthritis Center (RIC-AC) and the Rheumatology and General Internal Medicine
 Divisions of the Northwestern Medical Faculty Foundation (NMFF-Rheum and NMFF-GIM), the
 practice of fulltime Northwestern University Feinberg School of Medicine faculty members,
 will be the sites where clients will be recruited for this trial. While on the same campus,
 these RIC and NMFF are physically separated from one another and have separate administrative
 structures.

 Both have more than adequate numbers of eligible clients to enroll in this study. Based on
 administrative data, more than 500 individual clients with RA and 700 individual clients with
 knee OA were seen at the RIC-AC in the past twelve months. This is an average of more than 40
 RA and nearly 60 knee OA clients a month, a number which is likely to grow as the practice
 has been experiencing an approximate 15% growth in clients per year. More than triple these
 numbers of RA clients are seen at the NMFF-Rheum practice annually. Com-parable numbers of
 knee OA clients are seen at RIC-AC and NMFF-Rheum. To assure ready access to knee OA
 subjects, NMFF-GIM will also be a site for those subjects. Over 700 unique clients with
 explicit ICD-9 CM visit codes for knee osteoarthritis or rheumatoid arthritis were identified
 for NMFF-Rheum from EPICcare electronic medical records just for the months May-July 2004;
 approximately 200 additional clients with osteoarthritis and 25 with rheumatoid arthritis
 were seen at the NMFF-GIM over the same period. Several hundred clients with RA and knee OA
 are currently enrolled in an IRB-approved research registry which should facilitate
 recruitment into this study.

 Enrollment and sustained participation in the proposed study will be enhanced because of the
 proven willingness of clients in these academic practices to participate in ongoing
 observational studies. Dr. Leena Sharma has been following a cohort of 300 subjects with knee
 osteoarthritis for the past 5 years. Drs. Pamela Semanik and George Liang (an NMFF
 rheumatology colleague) have been able to recruit 185 and 311 RA clients respectively for
 their studies within one year. Based on this and other similar experiences, we expect
 attrition or lost to follow-up rates of less than 10% per one year and less than 20% over two
 years. Practice newsletters and the presence of familiar and friendly research assistants
 will enhance and sustain interest in ongoing research initiatives at both sites. Study
 interviews will be conducted at the convenience of the subject, either face to face or on the
 telephone using computerized telephone interview software. Institutional Review Board
 approval has already been obtained for collecting medical record and health status data on RA
 clients at the NMFF-Rheum site and physical activity and health status data on both knee OA
 and RA clients at the RIC-AC.

 Description of the consent process. Eligible clients will be informed of this study by the
 participating physicians of the RIC-AC and the NMFF-Rheum and NMFF-GIM practices by mail and
 at the time of a scheduled clinic visit.

 1. Mailings of study announcements to participants listed in the IRB-approved RA and knee
 OA client registries at RIC-AC, NMFF-Rheum, and NMFF-GIM. At the inception of the study,
 participating physicians will request retrospective ICD-9 coded visit data from RIC-AC,
 NMFF-Rheum, and NMFF-GIM for all clients coded with RA or adult knee OA (diagnosis codes
 714.0 or 715.96, excluding clients with v codes for aftercare of a previous joint
 replacement) seen at the 3 sites during the previous 12 months (Month 1). These visit
 data contain client names, addresses and phone numbers. By the end of project month 2,
 all clients who were identified from the registry as having relevant prior visit codes
 will be mailed a study solicitation letter, with a cover letter signed by their
 attending clinic physician, with a consent form and stamped return envelope for signed
 consent or refusal to participate. This mailing will provide study investigator phone
 numbers for participants to obtain further information. For those willing to
 participate, study coordinators will be able to screen for eligibility, including
 information on prior or immanently scheduled knee replacement surgery, as well as the
 date of clients' next regularly scheduled clinic appointment (if known). Consent
 materials will describe the need for six no-cost study visits with transportation and
 meal reimbursement policies.

 Within two weeks of the initial mailing, study personnel will initiate telephone contact
 with IRB-approved registry clients who have not responded to the mailing to further
 explain the study and determine interest in study participation. If interested, a second
 mailing will be made to these clients as needed. Medical records for all registry
 clients who return signed informed consent will then be reviewed to determine
 eligibility. Subsequent clinic schedules will be examined for consented, eligible
 clients and patient reported MD appointment times on a continuous basis to determine
 each client's next upcoming scheduled physician visit. Consented clients will be
 contacted again by phone within about six weeks of a regularly scheduled clinic visit.
 Based on the date of this forthcoming physician appointment, clients will be scheduled
 for a baseline study visit (with maximum flexibility to arrange weekday or weekend study
 visits at the patient's convenience) approximately three weeks before the "index" or
 baseline physician appointment. This entire process will be repeated, at study months 8
 and 16, to assist in meeting enrollment targets

 2. In-Person Enrollment. Clients not reachable by phone or mail, who prefer being enrolled
 in person, or who are not in the registry but are identified by their physicians as
 potential subjects at the time of an initial clinic visit, will be directly approached
 for participation by study coordinators at the time of a clinic visit. Written
 information from these physicians will be given to eligible clients to read in the
 waiting room upon arrival at the clinic and a short video about the study will be
 available for viewing before or after the visit. During the clinical visit the physician
 will discuss the opportunity for the client to participate in this study of physical
 activity and health status and factors that are associated with good and poor health
 status and will answer any questions that arise. If the client agrees to participate, a
 research assistant will further explain the study in detail, obtain written informed
 consent, and schedule an in person and telephone interview to collect study data. If a
 client consents, and is deemed eligible after a subsequent medical record review, the
 date of their next regularly scheduled follow-up physician visit will be used to
 determine the timing of their initial baseline study assessment visit. Non-eligible
 clients will be thanked for their time and interest, and added to the registry for
 future study notification, if desired.

 The Pre-Randomization (Baseline) Study Assessment Visit (See Figure 2) At the baseline study
 assessment visit, a study coordinator will fit all participating clients with the Actigraph
 accelerometer, provide instructions and packaging for mailed return, perform the observed
 physical function test battery, and schedule the first telephone interview one week later
 (about two weeks prior to the index clinic visit) at clients' convenience. This will enable
 telephone interview data (including the HRQOL and physical activity data) to refer the same
 week that the Actigraph data are being recorded. Clients will also be advised of prospective
 dates for five subsequent study assessment visits, the first two at three month intervals,
 the final three at six month intervals, which will be entirely unrelated to any subsequent MD
 visits.

 Randomization and the Index Physician Visit (See Figure 2) Randomization will be stratified
 by diagnosis (RA vs. knee OA), by site (RIC-AC vs. NMFF-Rheum for subjects with RA, RA-AC vs.
 NMFF-Rheum vs. NMFF-GIM for subjects with knee OA), and by level of disease- specific
 physical function (above or below specified cutpoints for the HAQ Disability Scale for RA
 subjects and the WOMAC-Physical Function Scale for knee OA subjects; the cutpoints set as the
 median values from RA and knee OA subjects who participated in previous clinical studies of
 RA and knee OA at RIC and NMFF). Consecutive clients within each strata will be randomly
 assigned to either PAM or control intervention.

 Randomization will occur to allow study personnel to notify each participant about their
 group assignment well before the index physician visit at which all subjects will receive MD
 physical activity counseling (full description is below). If selected into the PAM group,
 clients will be requested to allow additional time after their existing physician appointment
 for an initial, no cost, expense-reimbursed visit with the physical activity manager. The
 description of the PAM program is below. If spending additional time after the index
 physician visit concludes is inconvenient for the client, a separate PAM study visit for
 experimental group clients will be scheduled as soon as possible thereafter. Other than
 potential interaction with physicians about referrals or other experimental group activities,
 the PAM study assessment visits will remain completely independent of study clients' medical
 care, which will proceed in a usual and customary manner. This is analogous to chronic
 disease management in other settings.

 Physician physical activity promotion to be given to all study subjects The physician
 physical activity promotion intervention, which is to be given at the index physician visit
 (Figure 2) is designed to be accomplished in less than 5 minutes, and includes a) determining
 whether the client is meeting the CDC physical activity recommendations, b) encouraging the
 client to work toward or maintain this level of physical activity, and 3) eliciting and
 discussing the client's questions and/or concerns about physical activity.

 There are two reasons for giving this intervention to both groups. First, it is standard
 practice in some, but not all, practices participating in this trial and second, it is
 postulated that PAM will only be successful if MD's support its goals.

 The Physical Activity Management (PAM) Program (See also Appendix)

 The physical activity management program draws on principles of Cox's model described
 earlier. Because the potential for positive patient health outcomes increases as the provider
 intervention/interaction is better fitted to the uniqueness of the patient (background,
 cognitive, affective, and motivational manifestations), the Physical Activity Management
 program will be conducted using a standard intervention protocol guided by the results from
 the ACTA assessment. The ACTA interview and self-score form provide opportunities for the
 client to reflect upon his/her physical activity and to identify the supports and barriers to
 participation. The client works with the physical activity manager to identify and select
 goals that s/he personally finds motivating. Together, the client and physical activity
 manager negotiate the strategies that will be needed to help the client achieve their
 self-identified goals. This may involve the physical activity manager:

 -  providing information about physical activity, community resources that are available to
 the client

 -  making referrals as necessary to other care providers

 -  helping the client to identify day-to-day activities or ways the client can incorporate
 more activity in their life

 -  allowing the client the ultimate decisional control.

 The intervention was revised following patient feedback and clinician experience with the
 pilot programs. The physical activity management program now consists of 6 components, in
 part based on work by Cimprich110: a verbal explanation of the purpose of the physical
 activity management program; identification of barriers and supports to physical activity and
 physical activity goals using the ACTA; guidance in developing an action plan, selecting ways
 to be more active and a plan for what to do if the client has difficulty increasing their
 activity; establishing an agreement in writing to increase their physical activity each week;
 a strategy of re-cording progress; and a verbal explanation of the plan for future meetings
 with the physical activity manager. The IMCHB recognizes the role of choice and
 self-determination in health behavior, the ability of the clinician's interaction style and
 intervention approach to support or discourage health behavior, and the dynamic impact of the
 patient's singularity profile on health outcomes 111. To optimize this feature, the client
 will negotiate with the physical activity manager a contract that outlines goals, commitment
 to increase activity, what to do if things go wrong, use of a pedometer, three monthly
 calendars on which to record daily steps and which includes a list of activities the client
 can try to increase physical activity, and a copy of an activity pyramid with lifestyle
 physical activity suggestions. The client is seen or contacted for physical activity
 management at base-line, 3, 6, 12, 18, and 24 months at which time the ACTA will be repeated.
 The client's physician(s) will receive a physical activity management summary report at these
 times. The client and physical activity manager will negotiate other contacts as may be
 indicated by the client's needs. 112, 113 An autonomy-supportive provider and health care
 environment are key intervention strategies to assist in initiating and maintaining behavior
 change. A detailed description of the protocol can be found in the Appendix.

 Self-determination theory distinguishes between autonomous and controlled behavior
 regulation. Autonomous behaviors are initiated and sustained to the extent that people
 experience a true sense of volition and choice, and act because of the personal importance of
 the behavior. Controlled behaviors are performed because the individual feels pressured,
 either by external or intrapsychic forces 114.The autonomy supportive physical activity
 manager encourages the client to maintain decisional control of the process, choosing
 activities at which they feel they are most likely to succeed but also in assisting in
 development of a plan for what the client can do if they have difficulty increasing or
 maintaining their physical activity. By continuing to maintain contact with the client over a
 2 year period, to revise plans and goal achievement as necessary, this intervention
 recognizes the need to begin with primarily volitional activities i.e., consciously chosen
 and implemented activities until they are integrated into an habitual routine in the clients
 everyday life.

 This autonomy-supportive intervention also is informed by the chronic disease management
 model of Wagner and colleagues by utilizing protocols, placing more clinical responsibility
 on an allied health professional, emphasizing patient education and increased access to
 clinical and community expertise, and by giving the physician greater availability of
 clinical information relevant to the client's physical activity.

 Follow-up Study Assessment Visits (Figure 2) All study clients will be scheduled for five
 subsequent study visits at 3, 6, 12, 18, and 24 months after the baseline assessment, at
 which Actigraph fittings, observed physical function tests, and subsequent telephone
 interview follow-up within a week will be provided for both experimental and control
 subjects. Clients who do not continue to be seen at the study clinics for clinical care will
 be encouraged to remain in the study. Reimbursement for parking and meals will be made at
 each visit.

 Randomization will occur to allow study personnel to notify each participant about their
 group assignment well before the index physician visit at which all subjects will receive MD
 physical activity counseling (full description is below). If selected into the PAM group,
 clients will be requested to allow additional time after their existing physician appointment
 for an initial, no cost, expense-reimbursed visit with the physical activity manager. The
 description of the PAM program is below. If spending additional time after the index
 physician visit concludes is inconvenient for the client, a separate PAM study visit for
 experimental group clients will be scheduled as soon as possible thereafter. Other than
 potential interaction with physicians about referrals or other experimental group activities,
 the PAM study assessment visits will remain completely independent of study clients' medical
 care, which will proceed in a usual and customary manner. This is analogous to chronic
 disease management in other settings.

 Physician physical activity promotion to be given to all study subjects The physician
 physical activity promotion intervention, which is to be given at the index physician visit
 (Figure 2) is designed to be accomplished in less than 5 minutes, and includes a) determining
 whether the client is meeting the CDC physical activity recommendations, b) encouraging the
 client to work toward or maintain this level of physical activity, and 3) eliciting and
 discussing the client's questions and/or concerns about physical activity.

 There are two reasons for giving this intervention to both groups. First, it is standard
 practice in some, but not all, practices participating in this trial and second, it is
 postulated that PAM will only be successful if MD's support its goals.

 The Physical Activity Management (PAM) Program (See also Appendix)

 The physical activity management program draws on principles of Cox's model described
 earlier. Because the potential for positive patient health outcomes increases as the provider
 intervention/interaction is better fitted to the uniqueness of the patient (background,
 cognitive, affective, and motivational manifestations), the Physical Activity Management
 program will be conducted using a standard intervention protocol guided by the results from
 the ACTA assessment. The ACTA interview and self-score form provide opportunities for the
 client to reflect upon his/her physical activity and to identify the supports and barriers to
 participation. The client works with the physical activity manager to identify and select
 goals that s/he personally finds motivating. Together, the client and physical activity
 manager negotiate the strategies that will be needed to help the client achieve their
 self-identified goals. This may involve the physical activity manager:

 -  providing information about physical activity, community resources that are available to
 the client

 -  making referrals as necessary to other care providers

 -  helping the client to identify day-to-day activities or ways the client can incorporate
 more activity in their life

 -  allowing the client the ultimate decisional control.

 The intervention was revised following patient feedback and clinician experience with the
 pilot programs. The physical activity management program now consists of 6 components, in
 part based on work by Cimprich110: a verbal explanation of the purpose of the physical
 activity management program; identification of barriers and supports to physical activity and
 physical activity goals using the ACTA; guidance in developing an action plan, selecting ways
 to be more active and a plan for what to do if the client has difficulty increasing their
 activity; establishing an agreement in writing to increase their physical activity each week;
 a strategy of re-cording progress; and a verbal explanation of the plan for future meetings
 with the physical activity manager. The IMCHB recognizes the role of choice and
 self-determination in health behavior, the ability of the clinician's interaction style and
 intervention approach to support or discourage health behavior, and the dynamic impact of the
 patient's singularity profile on health outcomes 111. To optimize this feature, the client
 will negotiate with the physical activity manager a contract that outlines goals, commitment
 to increase activity, what to do if things go wrong, use of a pedometer, three monthly
 calendars on which to record daily steps and which includes a list of activities the client
 can try to increase physical activity, and a copy of an activity pyramid with lifestyle
 physical activity suggestions. The client is seen or contacted for physical activity
 management at base-line, 3, 6, 12, 18, and 24 months at which time the ACTA will be repeated.
 The client's physician(s) will receive a physical activity management summary report at these
 times. The client and physical activity manager will negotiate other contacts as may be
 indicated by the client's needs. 112, 113 An autonomy-supportive provider and health care
 environment are key intervention strategies to assist in initiating and maintaining behavior
 change. A detailed description of the protocol can be found in the Appendix.

 Self-determination theory distinguishes between autonomous and controlled behavior
 regulation. Autonomous behaviors are initiated and sustained to the extent that people
 experience a true sense of volition and choice, and act because of the personal importance of
 the behavior. Controlled behaviors are performed because the individual feels pressured,
 either by external or intrapsychic forces 114.The autonomy supportive physical activity
 manager encourages the client to maintain decisional control of the process, choosing
 activities at which they feel they are most likely to succeed but also in assisting in
 development of a plan for what the client can do if they have difficulty increasing or
 maintaining their physical activity. By continuing to maintain contact with the client over a
 2 year period, to revise plans and goal achievement as necessary, this intervention
 recognizes the need to begin with primarily volitional activities i.e., consciously chosen
 and implemented activities until they are integrated into an habitual routine in the clients
 everyday life.

 This autonomy-supportive intervention also is informed by the chronic disease management
 model of Wagner and colleagues by utilizing protocols, placing more clinical responsibility
 on an allied health professional, emphasizing patient education and increased access to
 clinical and community expertise, and by giving the physician greater availability of
 clinical information relevant to the client's physical activity.

 Follow-up Study Assessment Visits (Figure 2) All study clients will be scheduled for five
 subsequent study visits at 3, 6, 12, 18, and 24 months after the baseline assessment, at
 which Actigraph fittings, observed physical function tests, and subsequent telephone
 interview follow-up within a week will be provided for both experimental and control
 subjects. Clients who do not continue to be seen at the study clinics for clinical care will
 be encouraged to remain in the study. Reimbursement for parking and meals will be made at
 each visit.
Inclusion Criteria:

 -  18 yrs. or older

 -  ACR criteria for KOA or RA

 -  Able to speak and read English

 -  Able to ambulate at least household distances

 Exclusion Criteria:

 -  Planned total joint replacement surgery in the next 2 years

 -  Contraindication to physical activity due to co-morbid condition

 -  Unable to perform basic self-care (functional class IV) or walk household distances

 -  Planned Relocation away from Chicago area in next two years