A Social Marketing Approach to Recruitment: The Resources for Enhancing Alzheimer’s Caregiver Health (REACH) Study Running Head: Social Marketing and Recruitment Linda Nichols, Ph.D. Memphis VA Medical Center and University of Tennessee Barbara Tarlow, Ph.D., R.N. Hebrew Rehabilitation Center for AgedResearch and Training Institute Jennifer Martindale-Adams, Ed.D. University of Tennessee Lou Burgio, Ph.D. University of Alabama, Tuscaloosa Robert Burns, M.D. University of Tennessee Dolores Gallagher-Thompson, Ph.D. Veterans Affairs Palo Alto Health Care System and Stanford University David Coon, Ph.D. Stanford University Delois Guy, Ph.D., R.N. University of Alabama at Birmingham Marcia Ory, Ph.D. National Institute on Aging Trinidad Arguelles, M.S. University of Miami Diane Mahoney, Ph.D., R.N., GPN Hebrew Rehabilitation Center for AgedResearch and Training Institute Laraine Winter, Ph.D. Thomas Jefferson University Correspondence and reprints requests: Linda Nichols, Ph.D. Memphis VA Medical Center 1030 Jefferson Aveneue Memphis, TN 38104 Linda.nichols@med.va.gov (901) 523-8990, ext 5082 (901) 577-7439 (fax) Abstract Text – 4577 words References – 872 words Tables - 3 2 Recruiting research subjects is one of the most challenging aspects of clinical research. While these difficulties are understood clinically, only recently have recruitment issues become a researchable topic.1-7 However, many recruitment studies continue to lack a theoretical framework for understanding factors affecting these processes.8 Social marketing principles provide a useful theoretical framework for organizing the recruitment activities inherent to clinical research and can help researchers identify the elements that can be manipulated to maximize the achievement of recruitment goals. The basis of social marketing is the application of marketing techniques to influence the behavior of target audiences in order to improve their welfare and that of society.9 While social marketing is more typically used in public health initiatives designed to change behavior,10 the use of marketing principles can enhance subject recruitment, which is critical to the success of any research study.11 The four Ps of product, price, place, and promotion, in conjunction with the concept of partners, are the basics of any marketing strategy - variables that marketers can alter to successfully sell a product.10 This article describes the application of social marketing principles as a theoretical framework to organize and understand recruitment activities in a multi-site intervention study. In the Resources for Enhancing Alzheimer’s Caregiver Health (REACH) project, investigators from multiple sites began with the same premise for product (intervention) development. General and site-specific recruitment strategies were developed to: define the target audience for the product (research subjects); develop the product (intervention); manage the price to the target audience (in time and trouble); improve accessibility (place); promote the study; and develop and work with partners. 3 REACH is a multi-site, randomized, controlled experimental study to evaluate the feasibility of different social, behavioral, technological, and environmental caregiving interventions on the health and well being of caregivers (CGs) of persons with dementia. In response to an National Institutes of Health (NIH) cooperative agreement for caregiver research sponsored by the National Institute on Aging (NIA) and National Institute of Nursing Research (NINR), the project targeted a diverse population of CGs of persons with dementia. The six clinical sites were located in Birmingham, Boston, Memphis, Miami, Palo Alto, and Philadelphia. The Coordinating Center was located in Pittsburgh. (See Table 1 for institutions). REACH was not only successful in overall subject recruitment (majority of sites recruited more than their target numbers), but also in recruiting the targeted ethnic/minority groups. The REACH cohort of 1222 caregiver/care recipient (CG/CR) dyads constitutes the largest national database of diverse CGs actively participating in intervention studies (see Table 1).. Recruitment goals were based on power analyses for detecting significant intervention effects of the different intervention strategies at the six different sites hence the different numbers across sites. Insert Table 1 about here Defining the Target Audience The first, and perhaps most important, part of a recruitment strategy is to determine the target audience. Once the target audience is identified, program components can be developed that address their needs, perceptions, and values.10 REACH's target audience included ethnic minorities, who have been underrepresented in prior dementia research.12-15 Each site focused recruitment efforts on the particular ethnic minority group available in their specific geographic area, taking into account the different factors that might motivate subjects to enroll in the study 4 and differences in subjects' feelings, attitudes, and beliefs about the proposed psychosocial interventions.16-17 Inclusion and exclusion criteria were developed to create a definable population of both CGs and CRs at the six sites. To maximize intervention benefits, CGs were family members who lived with the CR, provided a significant amount of care, and had been providing care long enough to understand the challenges of caring for someone with dementia and problem behaviors. CRs had disease that would conceivably “burden” CGs, yet who would remain manageable at home over the eighteen months of data collection. In addition to the inclusion and exclusion criteria across sites (see Table 2), all sites except Memphis had additional site-specific inclusion and exclusion criteria related either to intervention design or to site-specific research questions. For example, at Boston, which had a phone based intervention, CGs had to have touch tone service; and Palo Alto’s research questions addressed issues related only to White and Hispanic women only and therefore limited its enrollment accordingly. Insert Table 2 about here Developing the Product Defining the Product In marketing, a product is defined as the behavior, goods, service or program exchanged for a price.10 In clinical research, the product is the intervention, and the intervention must meet the needs, wants, interests or desires of the target audience – the potential research participants. The basic REACH product was defined by NIH and NINR as social and behavioral interventions – the most promising technological and community based interventions to enhance family caregiving for Alzheimer's Disease and related disorders, particularly among minority families. From this broad product definition, each REACH site further defined a caregiving intervention or 5 product to meet the needs of its target audience, including the ethnic minority group at each site.18 See Table 3 for interventions - the site specific products. Insert Table 3 about here Competition for the Product A significant obstacle to recruiting potential research subjects for participating in interventions is the amount of competition for their time and energy. At the Boston site, for example, the number of research and clinical drug trials recruiting Alzheimer’s patients markedly increased at the time of REACH recruitment, resulting in intensive competition for subjects. During the course of Boston’s recruitment period there were, on average, 15 studies per month recruiting older adults in a regional recruitment program19-20 as well as 45 studies listed in the local Alzheimer's Chapter's directory of research opportunities.21 Participation in another ongoing study may be a formal exclusion criterion or, if not an exclusion, may be so time consuming that individuals cannot participate in other studies. In addition, the presence of other resources in a community, such as case management services and on-going support groups sponsored by Alzheimer's Association chapters, social service agencies and some health plans may give potential participants the impression that sufficient resources negate the need for participating in unproved or non pharmacological interventions. Managing the Price In marketing, price is defined as the cost to the target audience member in money, time, effort, lifestyle, or psyche, of engaging in the behavior. In recruitment, there also is a cost to the target audience member (potential or actual subject) for participating in a research study. These costs are in addition to those that may be required to implement the behavior change (which is the usual definition of price). For CGs, costs for participation in an intervention can be high, 6 particularly if respite or sitter service is not available. The research participant must perceive the cost of participating in the intervention to be a fair exchange for the benefit associated with the behavior change or for an altruistic benefit, such as helping other CGs in the future. Types of Costs While there was no actual monetary "charge” for any of the REACH interventions, participants nevertheless experienced a cost for joining the research project. Part of this cost was fixed across sites, while another part varied across sites and across intervention settings. One common cost in research studies is data collection. The 393 item REACH core data collection battery was a “fixed cost” across sites, taking CGs an average of 60-90 minutes to complete every six months. Each site added other measures to the core battery to investigate site-specific research questions. These site-specific batteries ranged in length from 29 questions requiring an additional 10 minutes at Boston to 200 questions and 60 additional minutes at Palo Alto. The number of data collection points also varied, with two sites including at least one additional data collection point between baseline and 18 months; thereby increasing costs to target audiences. Moreover, while five sites ended data collection at 18 months, Memphis extended data collection to 24 months. An associated cost in REACH was actual intervention time. At several sites, interventions and data collection occurred at the same visit, extending the amount of time required of CGs (and perhaps CRs) per visit, but decreasing the number of trips required. The duration of each active face-to-face intervention (not control/comparison groups) ranged from 0 at Boston (due to the computer interface) to 180 minutes per workshop at Birmingham. The frequency of intervention contact varied across sites ranging from weekly to monthly to every three months. These time costs affect homemaker, retired, and employed CGs differentially, as 7 they compete not only with caregiving tasks, other familial obligations, and personal needs, but also with wage earning hours. The time necessary for data collection and the time required to conduct interventions are not the only costs to research participants as is common in other studies.22-23 Across the sites, 74 participants cited intervention or data collection length as reasons for discontinuing. In Memphis, where neither data collection nor intervention were conducted in the home and where people might travel many miles from rural areas to see their primary care physicians, travel time was a major cost for participants. For many CGs, especially those with frail CRs, travel often subsumed other costs. For example, CGs might require additional time to prepare their CRs for travel, might need special transportation and thereby incur the monetary costs of that transportation, might experience the cost and difficulty of hiring a sitter or finding a family member to sit with the care recipient, and fatigue and additional behavioral problems involved with taking the CR outside the familiar environs of home. For some participants, travel and transportation proved to be an overwhelming cost. Other costs were unique to specific sites. For example, due to the focus on behavior problems, Birmingham CGs were asked to maintain a daily Behavioral Log throughout the 18 month study period. Although the tracking system was designed to minimize CG effort, extra work and time were required. Palo Alto's Coping with Caregiving class participants were asked to complete weekly homework assignments as a means of practicing skills taught in class sessions. Minimizing Costs In marketing, an important pricing principle is the marketer's ability to reduce or minimize consumer cost. At the onset of the REACH project, the majority of sites decided to 8 provide minimum services, such as payment for interviews, basic educational material on dementia and caregiving topics, and active listening to caregiver concerns to the comparison/control groups to balance the cost of participating in data collection. In addition, Birmingham, Boston, Memphis, and Palo Alto offered to enroll their control/comparison groups in more intensive interventions after completion of data collection. All but two sites paid participants for data collection or intervention participation. For these two sites, whether a financial incentive might have motivated individuals who refused to participate remains unclear. In a substudy of REACH refusers in Boston, investigators did offer a monetary incentive in combination with a one time only study contact and found little difficulty in recruiting participants.3 Some REACH sites did follow-up interviews by telephone to minimize participants' travel costs. Palo Alto provided funding for respite for the CR and provided transportation for the CG to support group and class sessions. Birmingham and Memphis provided a sitter and transportation (on an as-needed basis) as well as parking for group training sessions, and intervention and/or data collection sessions. To reduce the cost of CG time, Birmingham relaxed its requirement of daily completion of the Behavioral Log during the intervention period. Both Miami and Palo Alto minimized CG costs by providing recruitment, intervention and data collection activities in the preferred language of the CG, either English or Spanish. An additional way in which Birmingham and Memphis decreased the psychic or emotional cost to the CG was to have the same researcher or interventionist see the CG each time. The rapport built over time appeared to be a significant factor in retaining participants in the study, as CGs often listed the interventionists in their support network. At Miami and Palo Alto, CGs and interventionists shared similar cultural backgrounds with interviewers, interventionists, and recruitment staff further reducing psychic 9 costs to CGs. Although CGs and interventionists did not always share the same gender and/or cultural background at other sites, interventionists were trained in cultural competency in the participants’ culture.24 Improving Accessibility (Place) In a research milieu, place can be conceptualized as where the individual will engage in the behavior or receive information about the behavior, either as part of the intervention or as part of recruitment. Intervention sites included participants’ homes, physicians’ offices, memory clinics and other health care institutions, dementia-focused organizations (such as adult day care) and other community sites. In many cases, these places were also recruitment sites. The more accessible the place is to the participant, for recruitment and for intervention, the more likely it is that participants will enroll in and remain in the study. Birmingham’s initial workshop and Palo Alto’s classes and support groups were conducted in churches and community sites such as senior centers, adult day centers, or adult day health care centers that were not only convenient, but also were neutral or appropriate sites for the cultural group recruited. Memphis conducted intervention and data collection during the care recipient's regularly scheduled physician's visit. Philadelphia, Miami, and Boston all conducted their interventions in the home, as did Birmingham after the workshop. Promoting the Study Promotions are defined as a combination of advertising, media relations, promotional events, personal selling, and entertainment to communicate information about the product to target audience members. An important component of promotion is to identify acceptable avenues that reach the target population. Given the emphasis on recruiting minorities into this study, REACH investigators at each site tailored and ensured recruitment strategies and media 10 expenditures took into account the needs and preferences of ethnic populations. For example, each REACH site used professionally designed brochures, with translations appropriate for the sociocultural context of local Hispanic populations (i.e., “memory loss.” instead of “dementia.” Strategies used by sites included: newspaper ads, articles, flyers, and advertisements in newsletters, newspaper ads, web sites, television and radio, targeted and mass mailings of brochures, magnets and other promotional items, community presentations, and community service. Newspaper ads are often not successful in generating referrals and this held true for REACH. The failure of newspaper ads to produce research referrals may be attributed, in part, to ads not targeting the individuals who need the service, eligibility of fewer persons, and callers knowing little about their “fit” with the project, as the amount of information in the ad is small. Newspaper advertising also is relatively expensive, typically costing $800-$1,600 for a series of ads. Nevertheless, newspaper ads proved useful in attracting some targeted REACH groups. For example, Birmingham newspaper ads were a viable recruitment tool for persons in the Black community disconnected from formal health care or social service networks. Philadelphia achieved good results with ads placed in neighborhood newspapers and in series, for 4-6 consecutive weeks. In contrast, ads and articles in newspapers targeting the Latino community were not successful in recruiting Hispanic CGs for Palo Alto. Although work-place newsletters were not successful, senior-focused newsletters from local hospitals and newsletters from Alzheimer's organizations were quite successful in generating participants at Boston, Miami, and Memphis. Targeted mailings were also successful, especially those with a personalized letter, while untargeted ones to a broad sample were not. Memphis, Boston, and Birmingham used the mailing lists of local Alzheimer’s agencies or sent 11 materials to Alzheimer's agencies for distribution to their subscribers/supporters. Birmingham also sent mailings to churches, while Palo Alto targeted Hispanic/Latino families through university clinics and home care groups. Philadelphia’s mailings targeted family CGs of people with memory loss who were on the local Area Agency on Aging’s waiting lists for in-home care. Boston employed the high-tech medium of its Web site, which also allowed for on-line screening of potential subjects. In Birmingham, Miami and Palo Alto, the REACH project was featured on several local television and radio public service announcements as well as news and health talk shows. Birmingham also aired a television feature that included interviews with REACH participants who personally endorsed the REACH program. Nationally broadcast news stories featuring the REACH project appeared on CNN and Headline News. In Miami and Palo Alto, Hispanic caregivers responded well to television health and talk shows, but Miami caregivers also responded well to radio programs, while Palo Alto caregivers did not. Community outreach also served as a vehicle for promoting the REACH study. Community forums, talks and lectures at professional and ministerial associations, meetings of local health and social service organizations, churches, adult day-care centers, support groups, civic organizations, and neighborhood associations served as avenues for informing other professionals and dementia CGs about research opportunities at several sites. During these events, REACH recruiters disseminated information about the project by talking with people and by distributing flyers, brochures, and magnets. Investigators at Miami learned that Cuban Americans preferred to be introduced to the concept of REACH within the context of a health education program. A time-consuming but successful tactic combined community service and recruitment. Memphis staff worked with the Alzheimer’s Association on a customer satisfaction survey that 12 included two questions on knowledge about REACH and interest in learning more about research studies. Boston's recruitment coordinator chaired committees for local Alzheimer's organizations.25 Palo Alto offered frequent free workshops on dementia to the public at various community sites and at well-advertised VA Memory Clinic locations to assess cognitive status in a familiar, non-threatening environment. These Palo Alto activities were offered in English, Spanish or both depending upon the needs and expectations of co-sponsors and the target audience. Working with Partners Although classic marketing theory does not include partners as one of its Four P's, the synergy of partners with place and promotion provides a powerful marketing strategy, particularly in the context of research. Partners are defined as other organizations involved with a social change effort or serving as conduits to target audiences. Partners played a major role in recruiting REACH participants. Recruiting efforts were particularly successful when the partners were located in a convenient or credible location, such as a physician’s office, or when promotion efforts were directly tied to the partner’s roles, such as providing information on REACH in an Alzheimer's day care newsletter. However effective partnering requires continued attention from the research staff. Partner Education. REACH sites provided their partners with information about the project, and also engaged in relationship building activities. For example, Birmingham researchers held a reception to provide a progress report of the research and to acknowledge the contributions of the Visiting Nursing Association (VNA) (a major recruitment resource). This strategy provided lower level employees an opportunity to interact with the REACH team. Recruiting through home health agencies allowed Birmingham researchers access to more Black 13 CRs and families who do not usually seek specialized dementia evaluations or treatments for their relatives. Palo Alto provided VA staff with educational information about the stresses of caregiving, so that appropriate family members were referred. In addition, Palo Alto and Memphis regularly placed notices about the REACH project in the VA newsletter and on the VA internal email system to remind staff about this unique service. Effective relationships with members of both formal and informal networks are essential in marketing a research study as both formal and informal service providers support participants. Memphis, Boston and Palo Alto provided training sessions at local Alzheimer's affinity group meetings, aging affinity groups, and local hospital systems. Members of these groups provide services to individuals with Alzheimer's or their CGs and were a good source of referrals for REACH. Palo Alto staff further strengthened their network partnerships by offering training to their partners, thereby creating a bridge for providing CG assistance within the community after REACH contact ended. This mechanism created a snowball referral system, particularly in Hispanic communities, where study participants and informal network members provided additional referrals based on their positive relationships with study staff. Partner Referrals and Recruitment. Recruitment efforts were particularly successful when the place was linked to one of the REACH partners. For example, in Miami, White nonHispanic subjects responded well to letters about the REACH project sent by their physician at the respective Memory Clinics. They often perceived the REACH project as an extension of the clinical services of the Memory Disorders Clinic. In Memphis, participants were recruited from their physician's office and seen at that office. To obtain referrals, the Memphis staff modified the successful pharmaceutical detailing strategy. At each visit to the office, REACH staff delivered recruiting reminders and provided 14 educational materials for the offices. Effective devices included sticky notes, magnets, brochures with accompanying holders to place in waiting rooms, and small seasonal treats for staff and patients to share (e.g., candy for Halloween with a REACH sticker on it). Weekly faxback forms provided by REACH staff enabled office staff to send a referral without writing out an additional fax form for each referral. Continued personal contact over the course of the study permitted research staff to learn the cultures – the norms, attitudes, behaviors and values – of the referring agencies and their staff and how best to work within those cultures. Some of the REACH sites provided incentives to their partners for referrals, including monetary rewards and movie tickets. However, this strategy must be investigated thoroughly in the planning phase since many Universities categorize this type of transaction as "fee-splitting" and prohibit the giving of money or gifts to referral sites. Barriers. Changes in partners can prove disastrous to recruitment efforts. Near the end of the study’s recruitment phase at Birmingham, changes in client eligibility criteria as well as in the reimbursement system of home health care agencies drastically reduced the number of persons eligible to receive services and resulted in personnel cuts at these agencies. Consequently, REACH staff experienced a commensurate decrease in referrals from these agencies. Although monetary incentives for successful referrals from the home health agencies were instituted to compensate for the loss, this measure proved ineffective in increasing referrals. A series of concomitant events stumped Boston researchers during recruitment. A major realignment of health care systems and the resulting downsizing during REACH’s first field year severely crippled recruitment efforts.26 Boston’s major academic health care facilities realigned into partnerships that markedly undermined research endeavors from non-partner agencies. The Boston site’s original academic medical partner merged with another hospital, triggering 15 downsizing and the closing of several clinics that had agreed to refer potential participants. A second referral site for Boston, which umbrellaed regional VNA and social service agencies, converted to for-profit facility status. The public relations administrator opposed partnering the study citing fear of possible negative publicity from the need to withhold services from participants randomized to the control group. The research staff at Palo Alto also encountered barriers spawned by serendipitous events. State propositions 187 and 209, broadly viewed as anti-immigrant and anti-affirmative action legislation, were enacted by California voters before and during REACH. These pieces of legislation erected barriers of mistrust between Hispanic community partners (and their clientele) and the REACH staff who were employed by large state university and federal government systems and who were marketing a federally-sponsored project. Research Partners. By virtue of the study’s structure, each of the REACH sites was partnered by the Coordinating Center, NIA and NINR. At the project’s inception, a recruitment and retention workgroup was assembled, composed of project managers and investigators from each clinical site, as well as members of the Coordinating Center and NIH. Work group members conducted monthly conference calls until recruitment was completed and conducted bimonthly calls thereafter. Once recruitment began, the Coordinating Center provided the workgroup and each site with monthly recruitment and retention figures for each site and for all sites combined. The workgroup shared tips and strategies, and worked individually with sites experiencing difficulties. Through this workgroup, all sites benefited from the advice given Boston by their social marketing consultant and Miami’s experiences using the Adoption Process Model, which is often used to market health education programs and to recruit participants.27 16 Conclusion Every research encounters obstacles that influence recruitment or retention.28-30 In fact, research shows that the number of subjects who meet entry criteria and agree to enter a study will be fewer, often by several fold, than original projections.31 Unpredictable health care or community forces that were not factors in the planning and design phase of a research study can influence its implementation. In extreme instances, these factors may determine the project’s success or failure; at a minimum they can influence a study’s timetable or recruitment goals, necessitate staffing changes, or require fiscal adjustments. The REACH project illustrates how unforeseen events, such as changes in the organization or reimbursement of health care, the simultaneous presence of other studies, a loss of referring partners, and political shifts unrelated to the study but influencing the target audience, can greatly affect the ability to recruit and retain participants, particularly in multi-site research. Applying a social marketing theoretical framework in the design phase of the study, rather than as a post hoc organizing principle, can alleviate many of the difficulties sites face in recruiting and retaining research participants. The hallmark of social marketing is close attention to the congruence among the target audience, the product, and the mechanisms for marketing the product (price, place, promotion, and partnering). To maximize this fit, researchers must develop not only a thorough understanding of the potential research subjects and their community, but must also expand the concept of partnership to include the participants and their community, "…embracing the experience and partnership of those we are normally content simply to measure”.32 Partnership or collaboration among researchers, participants, and their community is increasingly recognized as critical to the success of a study.32-34 Partnering will not eliminate unforeseen difficulties but can help alleviate the damage they caused. In the initial phase of a 17 study, collaboration ensures the development of research methodologies that are consistent with community values, realities, and expectations. As a study progresses, researchers who have designed and implemented a study congruent with the culture of the community and who function as partners are more likely to recognize developing trends or events that have implications for the study. Frequently, researchers find themselves “blind-sided” by health care organization or financing changes that negatively impact some aspect of the study. Applying social marketing techniques that foster collaboration enables researchers and the community to quickly identify and implement alternative strategies. A social marketing framework enhances the congruence between the aspirations of researchers and the goals of the community. Decisions about the format and about conduct of the intervention and about recruitment and retention practices are reached with a full understanding of the culture of the community; and in the best case scenario, with the assistance and collaboration of the community.34 Congruence between the needs, wants, and preferences of the target audience and the researchers is pivotal in facilitating the research process. The ultimate goal of research is to develop and test interventions that will be broadly implemented. Research conducted using a social marketing perspective is more likely to be acceptable to a wider target audience than those who participate in the initial study. By following a social marketing framework, the researchers’ understanding of the needs, wants, and preferences of the target audience can be easily expanded to the general audience. 18 Acknowledgement This research was supported through the Resources for Enhancing Alzheimer’s Caregiver Health (REACH) project, which is supported by the National Institute on Aging and the National Institute of Nursing Research (Grants: U01-NR13269, U01-AG13313, U01-AG13297, U01AG13289, U01-AG13265, U01-AG13255, U01-13305). 19 References: 1. Anderson RT, Ory MG, Cohen S, McBride J.S. Contexts of Aging and Issues in Older Adults Adherence to Health Interventions. Controlled Clinical Trials. (forthcoming) 2. Arean P, Gallagher-Thompson D Issues and recommendations for the recruitment and retention of older ethnic minority adults into clinical research. Journal of Consulting and Clinical Psychology, 1996;64: 875-880. 3. Tarlow B, Mahoney D. The cost of recruiting Alzheimer's Disease caregivers for research. Journal of Aging and Health. November 2000. 4. Picot SF, Stuckey JC, Humphrey SW, et al. Cultural assessments and the recruitment and retention of African Americans into Alzheimer’s Disease Research. Journal of Aging and Ethnicity. 1996;1:5-18. 5. Prohaska T. The research basis for the design and implementation of self-care programs. In Ory MG, DeFriese, GH, eds. Self Care in Later Life, New York: Springer Publishing Company, 1998:62-84. 6. Young RF, Solakumni E, Young JH, Peters J. Issues of recruitment and retention in Alzheimer’s research among African and White Americans. Journal of Aging and Ethnicity. 1996;1(1):19-25. 7. Whelton P, Bahnson J, Appel L, Charleston J, Cosgrove N, Espeland MA, et al. Recruitment in the trial of nonpharmacologic intervention in the elderly (TONE). Journal of the American Geriatrics Society. 1997;45;185-193. 8. Levkoff S, Prohaska T, Weitzman PF, Ory MG. Recruitment and Retention in Minority Populations: Lessons Learned in Conducting Research on Health Promotion and Minority Populations. Journal of Mental Health and Aging. 2000;6(1). 20 9. Andreason, A. Marketing social change: Changing behavior to promote health, social development, and the environment. 1995. San Francisco: Jossey Bass. 10. Siegal M, Doner L. Marketing public health: Strategies to promote social change. 1998. Gaithersburg, MD: Aspen. 11. Nichols LO, Malone C, Tarlow B, Loewenstein D. The pragmatics of implementing intervention studies in the community. In: Schulz et al., Handbook of dementia caregiving intervention research, pp. 127-150. 2000. NY: Springer, in press. 12. Aranda MP, Knight BG. The influence of ethnicity and culture on the caregiver stress and coping process: A sociocultural review and analysis. The Gerontologist. 1997; 37: 342-354 13. Shadlen MF, Larson EB. Unique features of Alzheimer’s disease in ethnic minority populations. In T. Miles (Ed.), Full-color aging: Facts, goals, and recommendations for America’s diverse elders, pp. 33-51. 1999. Washington, D.C.: The Gerontological Society of America. 14. National Alliance on Cargiving & American Association of Retired Persons (AARP). Family caregiving in the U.S: Findings from a national survey. 1997. Authors: Bethesda, MD. 15. Ory, MG, Yee JL, Tennstedt SL, Schulz R. The extent and impact of dementia care: Unique challenges experienced by family caregivers. In R Schulz (Ed.),. Handbook on dementia caregiving, pp. 1-32. 2000. NY: Springer Press. 16. Sutton SM, Balch GI, Lefebvre RC. Strategic questions for consumer-based health communications. Public Health Reports. 1995;110:725-733. 21 17. Kelty MF, Hoffman R, Ory MG, Harden JT. Behavioral and sociocultural aspects of aging, ethnicity and health. In RM Eisler, M Hersen (Eds.), Handbook of gender, culture and health, pp. 139-158. 1999. Mahway, NJ: Lawrence Erlbaum Associates. 18. Gallagher-Thompson D, Arean P, Coon D, Menendez A, Takagi K, Haley W, et al. Development and implementation of intervention strategies for culturally diverse caregiving populations. In R. Schulz (Ed.), Handbook on dementia caregiving, pp. 151-185. 2000. NY: Springer Press. 19. Rosenberg R. Harvard Cooperative Program on Aging Newsletter, No 18, Jan, Research Opportunities. 1998:8-11 20. Rosenberg R. Harvard Cooperative Program on Aging Newsletter, No 19, May, Research Opportunities, 1998:11-13. 21. Alzheimer's Association of Eastern Massachusetts. Directory of Research Opportunities for People with Alzheimer's Disease and Their Families. 1997. Cambridge, MA, Fidelity Press. 22. Andererson LA, Fogler J, Dedrick RF. Recruiting from the community: Lessons learned from the Diabetes Care for Older Adults Project. Gerontology. 1995;35(3); 395-401. 23. Boles M, Getchell WS, Feldman G, McBride R, Hart RG. Primary prevention studies and the healthy elderly: evaluating barriers to recruitment. Journal of Community Health. 2000;25 (4): 279-92. 24. Kagawa-Singer, M. Addressing issues for early detection and screening in ethnic populations [review]. Oncology Nursing Forum. 1997; 24:1705-1711. 25. Mahoney, D. Marketing health care programs to older adults. Strategies for success. Geriatric Nursing. 1994;15:10-15. 22 26. Corrigan J, Mechanic R, Solomon L, Williams C. Health System Change in Boston, MA., The Community Tracking Study. 1997. Washington, D.C.:Center for Studying Health System Change. 27. Backer T E, Rogers EM. (Eds.). Organizational aspects of health communication campaigns: what works? 1993. Newbury Park, CA: Sage Publications, Inc. 28. Dowling G, Wiener C. Roadblocks encountered in recruiting patients for a study of sleep disruption in Alzheimer's disease. Image: Journal of Nursing Scholarship. 1997;29:59-64. 29. Graham S, Hellmann R, Marshall J, Freudenheim J, Vena J, Swanson M, et al. Nutritional epidemiology of postmenopausal breast cancer in western New York. American Journal of Epidemiology. 1991;134:552-566. 30. Thompson M, Heller K, Rody C. Recruitment challenges in studying late-life depression: Do community samples adequately represent depressed older adults? Psychology and Aging. 1994;9:121-125. 31. Hulley S, Cummings S. Designing Clinical Research. 1988. Baltimore: Williams and Wilkins. 32. Schwab M, Syme SL. On paradigms, community participation, and the future of public health. American Journal of Public Health. 1997;87:2049-2051. 33. Levkoff S, Levy B, Weitzman PF . The Matching Model of Recruitment. Journal of Mental Health and Aging. 2000;6(1):29-39. 34. Kone A, Sullivan M, Senturia KD, Chrisman NJ, Ciske SJ, Krieger JW. Improving collaboration between researchers and communities. Public Health Reports, 2000;115 (23):243-8. 23 Table 1- Recruitment by site and ethnicity Birmingham Boston Memphis Miami Palo Alto Philadelphia All sites Randomized 140 100 245 225 257 255 1222 % White 57.1 79.0 58.6 49.8 57.2 48.2 56.0% % Black 42.9 16.0 39.8 0.0 0.0 47.8 24.2% % Hispanic (Mexican) 0.0 0.0 0.0 0.0 30.0 0.0 6.3 % % Hispanic (Cuban 0.0 0.0 0.4 50.2 0.8 0.0 9.5 % % Hispanic (Other) 0.0 2.0 0.4 0.0 12.1 0.0 3.2 % % Other 0.0 3.0 0.8 0.0 0.0 2.0 0.8 % 24 Table 2. REACH Subject/Participant Criteria: Shared Criteria Across All Sites Caregiver Inclusion Criteria Caregiver Exclusion Criteria > 21 years old Life expectancy < 6 months Family member Active treatment for cancer Telephone > 3 acute hospitalizations/past year Plan to remain in area for study duration Planned placement of CR (within 6 months) Caregiver > 6 months Involved in another clinical trial for caregivers Daily > 4 hours supervision/assistance Other (e.g., transportation, commitment, hesitancy) Live in the same house with CR Care Recipient Inclusion Criteria Care Recipient Exclusion Criteria NINCDS-ADRDA (MD diagnosis) or Blindness or deafness if prohibit from data collection cognitive impairment (MMSE < 23) or participation in interventions Two IADL or one ADL impairment(s) Active treatment for cancer > 3 acute hospitalizations/past year Schizophrenia Dementia secondary to head trauma MMSE = 0 and bedbound more than 22 hours/day Life expectancy < 6 months 25 Table 3. Summary of REACH Intervention Conditions From: Rubert and Czaja Site Intervention Description Birmingham Skill Training Behavior management skills training; caregiver University of problem solving Alabama, Minimal Support Interviewer provides active listening and empathic Birmingham, Control comments Memphis Information and Written AD information, referrals to AA University of Referral Tennessee, Behavioral Care Tuscaloosa Memphis VA Medical Information plus behavior management skills training Enhanced Care Center Information care + behavioral management care + stress management. Relaxation training, coping strategies. Miami Family-based Structural Family system therapy to enhance family support University of Multi-system In-home and functioning. Miami Interventions FSMII + Computer Family therapy plus computer telephone system to Telephone Integration facilitate family communication, messaging, System conferencing, respite functions and social support Minimal Support Interviewer provides active listening and empathic Control comments 26 Palo Alto Coping with Caregiving Psychoeducational class to teach coping and mood Stanford Class management skills University, Enhanced Support Support groups patterned after local community Veterans Group support groups, standardized meeting frequency, Affairs Palo duration, length of time in group and educational Alto Health materials. Care System Minimal Support Interviewer provides active listening and empathic Control comments Philadelphia Environmental Skill In-home caregiver problem solving and use of Thomas Building environmental strategies to manage behavioral Jefferson problems and ADL limitations University Usual Care Provision of education and referral materials. Boston REACH for TLC Monitors caregiver stress levels, voice mail support Hebrew group, provides expert advice, care recipient Rehabilitation behavioral distraction to reduce disruptive behaviors. Center for Usual Care Aged- consultation available, support group referral Research and Training Institute Pittsburgh, University of Pittsburgh Medical services and testing, social work Coordinating Center 27