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New studies give clear guidance on how to better recruit volunteers for Alzheimer's clinical studies

14.07.2009
Overcoming the biggest obstacle to improving Alzheimer's treatments

Partnering with local physicians, working with local clinics, and conducting educational seminars and health fairs were found to be the most effective tools in recruiting people for Alzheimer's clinical studies, according to new research reported today at the Alzheimer's Association 2009 International Conference on Alzheimer's Disease (ICAD 2009) in Vienna.

Surprisingly, patient registries and Internet recruiting were found to be much less successful recruitment strategies, according to staff at the U.S. Alzheimer's Disease Centers (ADCs). The National Institute on Aging (NIA) funds 30 ADCs at major medical institutions across the nation. (http://www.nia.nih.gov/Alzheimers/)

"Second only to inadequate funding, recruiting participants for clinical studies is the single greatest barrier to developing better treatments for Alzheimer's disease," according to William Thies, PhD, Chief Medical & Scientific Officer at the Alzheimer's Association. "These studies give us clear information – from people who are conducting large scale clinical trials now – on how we may recruit participants better and faster in the future."

In another study looking specifically at recruiting African Americans for Alzheimer's genetics studies, researchers in North Carolina and Florida found that having a relative with the disease, use of minority study personnel, and monetary compensation were the most powerful incentives for participation in research.

Successful Recruitment Strategies from the U.S. Alzheimer's Disease Centers

Tamara Markgraf, MBA, Research Program Manager at the Wisconsin Alzheimer's Disease Research Center in Madison and colleagues interviewed 22 administrators and outreach staff from 20 ADCs about their recruitment strategies and outcomes.

They found that all ADCs utilize community outreach and educational seminars to promote clinical study participation. 17 centers visit health-fairs; 15 recruit from patient clinics. 10 centers reported that the most successful recruitment strategy was recruitment from clinics. Other successful strategies included word of mouth (4) and referrals from physicians (3).

All the ADCs reported partnering with outside organizations such as the Alzheimer's Association. Several have linked with churches, church groups, or church leaders in efforts to boost recruitment, in particular minority recruitment. Many tried sending out postcards to high density postal codes, and other mass mailings. Advertising was not an option for most of those who reported, due to budget constraints.

Recruitment hurdles reported included minority recruitment (8) and inclusion/exclusion criteria (6). Half of ADCs utilize a recruitment registry with databases ranging from 200 to more than 1,500. Interestingly, only six of 20 sites reported their registry as a "beneficial" recruitment tool. In addition, although all ADCs have a website, few (7) see it as a beneficial, active tool for clinical study recruitment. In fact, the Internet was found to be the least successful reported strategy. Despite identified hurdles, 13 of the ADCs report meeting annual recruitment goals.

"Our data suggest that successful recruitment is a result of a comprehensive recruitment plan," Markgraf said. "The successful ADCs promote study participation while conducting community educational events, and they actively partner with outside physicians. The professionals we interviewed told us that they best way to meet recruitment goals is to get the support of the local community and physicians."

Encouraging African American Participation in Alzheimer's Genetics Studies

Despite government regulations on inclusion of women and minorities in clinical research, such as the 1993 Revitalization Act, ethnic minorities continue to be underrepresented in biomedical research studies and clinical trials, including Alzheimer's studies. As part of an effort to recruit African Americans for an Alzheimer's disease genetics study, Goldie S. Byrd, PhD, Nathan F. Simms Endowed Professor in the Department of Biology at North Carolina A&T State University, and colleagues surveyed 500 African American adults to investigate perceptions and inform recruitment efforts for Alzheimer's research participation.

They found that having a relative with the disease, use of minority study personnel, and monetary compensation were the most powerful incentives for participation of African Americans in Alzheimer's genetic research. In addition, partnerships with churches and influential community leaders were found to yield significantly greater interest and participation.

"Among survey respondents who had never participated in a research study, 60 percent of those in the 60 to 69 age range with a family history of Alzheimer's were very willing to participate, independent of their knowledge of historical research atrocities such as the Tuskegee Syphilis Study," Byrd said.

The researchers found that African Americans were willing to participate in several types of research studies, including surveys, focus groups, clinical trials, and genetic studies – surveys were the most preferred form of participation in all age groups. Though 72% of respondents indicated a willingness to participate if blood samples were needed, enthusiasm for such studies diminished as age increased.

"Large percentages of African Americans are willing participants for Alzheimer's genetic studies, if culturally sensitive techniques are used to recruit them," Byrd said.

Why People with Alzheimer's and Their Relatives Participate in Clinical Studies

In order to further inform the clinical study recruitment process, Ulrika Akenine, MS, a registered nurse at the Memory Clinic, Geriatrics Department, Karolinska University Hospital, Stockholm, and colleagues investigated the motives and expectations of people with dementia and their relatives for participating in Alzheimer's research trials.

For the study, 19 people with mild to moderate Alzheimer's, average age 66 years, and their relatives (20 caregivers) participating in five different vaccination studies at the clinic answered a questionnaire during October and November 2008. Primary motives to participate for both patients and their relatives were helping science and contributing to research, hope for easing of symptoms or cure, and getting access to more information about the disease. Patients and relatives reported that access to medical expertise and regular health checkups were advantages of study participation.

Among the disadvantages were the risk of receiving placebo, discomfort/pain during sample-taking and exams, and the risk of side effects. People with Alzheimer's reported to a greater extent than caregivers that they did not see any disadvantages to participating in a research study.

"Research on Alzheimer's is intense, and there is great hope for new drugs that will ease the impact of the disease," Akenine said. "Many people with dementia and caregivers will face the question of whether to participate in clinical trials. We hope our research helps inform healthcare providers, advocacy organizations, and pharmaceutical companies who have increasing need to address these questions."

About ICAD 2009

The 2009 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD 2009) brings together more than 5,000 researchers from 60 countries to share groundbreaking research and information on the cause, diagnosis, treatment and prevention of Alzheimer's disease and related disorders. As a part of the Association's research program, ICAD 2009 serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community. ICAD 2009 will be held in Vienna, Austria at Messe Wien Exhibition and Congress Center from July 11.

About the Alzheimer's Association

The Alzheimer's Association is the leading voluntary health organization in Alzheimer care, support and research. Our mission is to eliminate Alzheimer's disease through the advancement of research, to provide and enhance care and support for all affected, and to reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimer's. For more information, visit www.alz.org.

Tamara S. Markgraf - Recruiting for Alzheimer's disease Research: A systematic review of recruitment techniques and challenges among NIH funded ADRCs (Funders: National Institute on Aging, John A Hartford Foundation, Hartford Center of Excellence in Geriatrics Medicine and Training)
Goldie S. Byrd - Ascertaining Older African Americans for Genetic Studies in Alzheimer's Disease (Funders: National Center on Minority Health and Health Disparities; National Institute on Aging)

Ulrika Akenine - Why AD patients and caregivers participate in randomized clinical trials (Self funded)

All materials to be presented at the 2009 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD 2009) are embargoed for publication and broadcast until the date and time of presentation at the International Conference on Alzheimer's Disease, unless the Alzheimer's Association provides written notice of change of embargo date/time in advance.

Recruiting for Alzheimer's disease Research: A systematic review of recruitment techniques and challenges among NIH funded ADRCs

Tamara S. Markgraf1,2, Whitney Wharton1,2, Caitlyn Cleary1, Katie Lorenze1, Madeline Zeisse1, Mitchell Daun1, Carey E. Gleason1,2, Kara Erwin1,2, Cynthia M. Carlsson1,2, Sterling C. Johnson1,2, Mark A. Sager1, Sanjay Asthana1,2

1UW Wisconsin - Madison, Madison, WI, USA; 2William S. Middleton Memorial Veterans Hospital, GRECC, Madison, WI, USA.

Contact e-mail: tsm@medicine.wisc.edu

Disclosure Block: T.S. Markgraf, None; W. Wharton, None; C. Cleary, None; K. Lorenze, None; M. Zeisse, None; M. Daun, None; C.E. Gleason, None; K. Erwin, None; C.M. Carlsson, None; S.C. Johnson, None; M.A. Sager, None; S. Asthana, None.

Background: According to the Alzheimer's Association, second only to funding, recruiting subjects is the single greatest barrier to developing better treatment and prevention strategies for Alzheimer's disease (AD). To examine factors influencing participation in AD research, investigators interviewed personnel from 20 Alzheimer's Disease Research Centers (ADRCs).

Methods: Researchers conducted a standardized phone interview with personnel from twenty NIH-funded ADRCs. Centers were queried about their recruitment strategies and outcomes. Transcripts were independently reviewed by investigators, and data were coded for analyses.

Results: Surveyed ADRCs were funded between 4 to 28 years (M=12); Number of investigators at each center varied from 2 to 23 (M=11), and number of support staff ranged from 5 to 100 (M=19). Sixty percent of centers have staff dedicated to subject recruitment and retention. All ADRCs utilize community outreach and educational seminars to promote participation. Seventeen centers visit health-fairs and fifteen recruit from patient clinics. Fifty percent of centers reported the most successful recruitment strategy was recruitment from clinics. Other successful strategies include word of mouth (N=4), referrals from physicians (N=3), community outreach (N=2), and memory screenings (N=1). Recruitment hurdles reported included minority recruitment (40%) and inclusion/exclusion criteria (30%). Additional recruitment barriers were space, staffing level, lack of interest, and loss to follow-up. Half of ADRCs utilize a recruitment registry with participation ranging from 200 to 1500+. Interestingly, only six sites report the registry as a beneficial recruitment tool. Despite identified hurdles, 65% of ADRCs report meeting annual recruitment goals. There was no correlation between presence of recruitment staff and 1) preferred method of recruitment or 2) a center's ability to meet recruitment goals. Furthermore, although all ADRCs have a website, few (35%) see it as an active tool for recruitment.

Conclusions: These data suggest that successful recruitment is a result of a comprehensive recruitment plan. The successful ADRC 1) promotes study participation while conducting community educational events, and 2) partners with outside physicians. Those interviewed agreed that without the support of lay community and physicians, recruitment goals are not met. The successful ADRC has built their program using educational seminars, free screenings, and a willingness to serve to the community.

All materials to be presented at the 2009 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD 2009) are embargoed for publication and broadcast until the date and time of presentation at the International Conference on Alzheimer's Disease, unless the Alzheimer's Association provides written notice of change of embargo date/time in advance.

Ascertaining Older African Americans for Genetic Studies in Alzheimer's Disease
Goldie S. Byrd1, Margaret Pericak-Vance2, Christopher L. Edwards3, Ashleigh Taylor1, Vinaya Kelkar1, Jennifer R. Byrd1, Takiyah D. Starks1, Dora Som Pimpong1, Yi-Ju Li3

1North Carolina A&T State University, Greensboro, NC, USA; 2University of Miami, Miami, FL, USA; 3Duke University, Durham, NC, USA.

Contact e-mail: gsbyrd@ncat.edu

Disclosure Block: G.S. Byrd, None; M. Pericak-Vance, None; C.L. Edwards, None; A. Taylor, None; V. Kelkar, None; J.R. Byrd, None; T.D. Starks, None; D. Som Pimpong, None; Y. Li, None.

Background: According to the Alzheimer's Association, Alzheimer's Disease (AD) occurs much more frequently in African Americans than Caucasians. In spite of governmental regulations on inclusion, such as the 1993 Revitalization Act, African Americans remain underrepresented at all levels of the clinical trials and biomedical research process for AD. Genetic studies of AD that require blood samples and target minority populations remain a challenge to design and execute based on significant reported difficulties in recruiting willing elderly minorities.

Methods: The recruitment goal of a larger AD study was to ascertain 2000 African Americans to participate in genetic studies of AD. We devised a recruitment model that included: 1. Hiring African Americans study personnel, 2. Developing culturally sensitive educational materials and advertisements, and 3. Partnering with African American community stakeholders. In addition, we developed a 50 question survey to investigate perceptions and to inform our recruitment efforts for AD research participation among African Americans.

Results: From 500 survey respondents, our data show that general open enrollment for genetic studies is insufficient for ascertaining large numbers of African Americans; however, strategic partnerships with churches and influential community leaders yield significantly greater interest and participation. Among persons who had never participated in a study, 60% of those in the 60-69 age range with a family history of AD, were very willing to participate, independent of their knowledge of historical research atrocities such as the Tuskegee Syphilis Study. African Americans were also willing to participate in several types of research studies including: surveys, focus groups, clinical trials and genetic studies. Though 72% of respondents indicated a willingness to participate if blood samples were needed, enthusiasm for such studies diminished as age increased. As expected, surveys were the most preferred form of participation in all age groups. Having a relative with the disease, use of minority study personnel, and monetary compensation were the most powerful incentives for participation in genetic research.

Conclusions: We conclude that large percentages of African Americans are willing participants for genetic studies. However, they require culturally sensitive methodologies that include reciprocity. These data are powerful in advancing recruitment of African Americans in genetic studies of AD.

All materials to be presented at the 2009 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD 2009) are embargoed for publication and broadcast until the date and time of presentation at the International Conference on Alzheimer's Disease, unless the Alzheimer's Association provides written notice of change of embargo date/time in advance.

Why AD patients and caregivers participate in randomized clinical trials
Ulrika Akenine1, Niels Andreasen1, Yvonne Freund-Levi2, Bengt Winblad2, Miia Kivipelto2

1Karolinska University Hospital, Huddinge, Sweden; 2Karolinska Institute, Stockholm, Sweden.

Contact e-mail: ulrika.lonnqvist-akenine@karolinska.se

Disclosure Block: U. Akenine, None; N. Andreasen, None; Y. Freund-Levi, None; B. Winblad, None; M. Kivipelto, None.

Background: With growing intensity of research related to Alzheimer's disease (AD) and large number of patients participating in clinical trials, there is increasing interest and need to clarify patients' situation in the studies. The aim of our study was to investigate the motives and expectations of patients and their relatives for participating in the Randomized Controlled Trials (RCT).

Methods: Altogether 19 (out of 20) AD patients and their relatives participating in five different vaccination studies at the Memory Clinic, Karolinska University Hospital, Huddinge, Sweden, answered a questionnaire with open and structured questions. The patients had mild-to-moderate AD mean MMSE 23 and age range was 66 years.

Results: The result showed that the motives to participate for both patients and their relatives were to help science/contribute to research, hope for easing of symptoms or cure, have access to information, and possibility to have their questions answered. Patients and relatives reported that access to medical expertise and regular health checkups were advantages of study participation. Among the disadvantages were the risk of receiving placebo, discomfort/pain during sample-taking and exams, and the risks of side effects and harm. Patients reported to a greater extent that they did not see any disadvantages in participating in a RCT, while their relatives expressed greater concern regarding the risk of receiving placebo, the risk for side effects and pain or discomfort for the participator. Both patients and relatives reported that they had received sufficient information about study participation before the study started, but as the desire for information was a common motive for study participation, the wish for more information remains through the study.

Conclusions: This study shows the motives of both patients and their relatives. A large numbers of patients and their caregiver will face the question whether to participate in RCTs, and health care providers, patient organizations, and pharmaceutical companies have increasing need to address these questions. To increase quality and compliance as well as to ensure that the ethical aspects of patient satisfaction are fulfilled in the RCT, more knowledge about patients' and their caregivers' motives and expectations of study participation is needed.

Niles Frantz | EurekAlert!
Further information:
http://www.alz.org

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