Recruitment of the elderly into a pharmacologic prevention trial

The Ginkgo Evaluation of Memory Study experience

Annette L. Fitzpatrick, Linda P Fried, Jeff Williamson, Patricia Crowley, Delilah Posey, Linly Kwong, Janet Bonk, Roberta Moyer, Joyce Chabot, Lara Kidoguchi, Curt D. Furberg, Steven T. DeKosky

Research output: Contribution to journalArticle

Abstract

The difficulty involved in recruiting healthy older adults into clinical trials, especially those involving pharmacologic agents, is an important issue in research. The Ginkgo Evaluation of Memory (GEM) Study, a double-blind, placebo-controlled randomized clinical trial evaluating Ginkgo biloba to prevent dementia, successfully recruited 3072 participants age 75 years and older at four U.S. sites from September 2000 through June 2002. Using targeted mailing lists, an estimated 243,400 study brochures were mailed out to potential participants. Subsequent attempts were made to reach 14,603 households by telephone, from which 12,186 (83.4%) successful contacts were made. Overall, telephone or in-person evaluations identified 2149 (17.6%) ineligible persons for cognitive (20.6%), medical (49.4%), or other (30.0%) reasons. A total of 6944 (57.0%) refused participation resulting in 3072 enrolled into the study, a recruitment rate of 25.2% based on telephone contacts made or 1.3% of all mailed brochures. Recruitment rates were stable over the 21-month enrollment period but were higher for the two urban centers than the two rural ones. Recruitment was dependent most on mailing lists available, density of older adults in the catchment areas, and Institutional Review Board restrictions. Men and persons under age 85 were more likely to enroll. Primary reason for refusals involved lack of interest (48.4%) or self-perceived poor health (16.2%). Over 9% were unwilling to give up current Ginkgo supplementation or would not accept assignment to placebo. An additional 7% did not want another medication and almost 4% had care-giving responsibilities which prevented involvement. Mass mailings were the most successful approach for recruitment at all four sites and the method through which the vast majority of interviewees had learned about the study. Information on the experience of the GEM Study recruitment may be helpful to other clinical trials attempting to randomize older adults into prevention trials.

Original languageEnglish (US)
Pages (from-to)541-553
Number of pages13
JournalContemporary Clinical Trials
Volume27
Issue number6
DOIs
StatePublished - Dec 2006

Fingerprint

Ginkgo biloba
Telephone
Pamphlets
Placebos
Clinical Trials
Research Ethics Committees
Dementia
Randomized Controlled Trials
Health
Research

Keywords

  • Aging
  • Alzheimer's disease
  • Clinical trial
  • Dementia
  • Elderly
  • Ginkgo biloba
  • Recruitment

ASJC Scopus subject areas

  • Pharmacology

Cite this

Recruitment of the elderly into a pharmacologic prevention trial : The Ginkgo Evaluation of Memory Study experience. / Fitzpatrick, Annette L.; Fried, Linda P; Williamson, Jeff; Crowley, Patricia; Posey, Delilah; Kwong, Linly; Bonk, Janet; Moyer, Roberta; Chabot, Joyce; Kidoguchi, Lara; Furberg, Curt D.; DeKosky, Steven T.

In: Contemporary Clinical Trials, Vol. 27, No. 6, 12.2006, p. 541-553.

Research output: Contribution to journalArticle

Fitzpatrick, AL, Fried, LP, Williamson, J, Crowley, P, Posey, D, Kwong, L, Bonk, J, Moyer, R, Chabot, J, Kidoguchi, L, Furberg, CD & DeKosky, ST 2006, 'Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience', Contemporary Clinical Trials, vol. 27, no. 6, pp. 541-553. https://doi.org/10.1016/j.cct.2006.06.007
Fitzpatrick, Annette L. ; Fried, Linda P ; Williamson, Jeff ; Crowley, Patricia ; Posey, Delilah ; Kwong, Linly ; Bonk, Janet ; Moyer, Roberta ; Chabot, Joyce ; Kidoguchi, Lara ; Furberg, Curt D. ; DeKosky, Steven T. / Recruitment of the elderly into a pharmacologic prevention trial : The Ginkgo Evaluation of Memory Study experience. In: Contemporary Clinical Trials. 2006 ; Vol. 27, No. 6. pp. 541-553.
@article{67cf61abc2714dc88bbb5f7d622968c7,
title = "Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience",
abstract = "The difficulty involved in recruiting healthy older adults into clinical trials, especially those involving pharmacologic agents, is an important issue in research. The Ginkgo Evaluation of Memory (GEM) Study, a double-blind, placebo-controlled randomized clinical trial evaluating Ginkgo biloba to prevent dementia, successfully recruited 3072 participants age 75 years and older at four U.S. sites from September 2000 through June 2002. Using targeted mailing lists, an estimated 243,400 study brochures were mailed out to potential participants. Subsequent attempts were made to reach 14,603 households by telephone, from which 12,186 (83.4{\%}) successful contacts were made. Overall, telephone or in-person evaluations identified 2149 (17.6{\%}) ineligible persons for cognitive (20.6{\%}), medical (49.4{\%}), or other (30.0{\%}) reasons. A total of 6944 (57.0{\%}) refused participation resulting in 3072 enrolled into the study, a recruitment rate of 25.2{\%} based on telephone contacts made or 1.3{\%} of all mailed brochures. Recruitment rates were stable over the 21-month enrollment period but were higher for the two urban centers than the two rural ones. Recruitment was dependent most on mailing lists available, density of older adults in the catchment areas, and Institutional Review Board restrictions. Men and persons under age 85 were more likely to enroll. Primary reason for refusals involved lack of interest (48.4{\%}) or self-perceived poor health (16.2{\%}). Over 9{\%} were unwilling to give up current Ginkgo supplementation or would not accept assignment to placebo. An additional 7{\%} did not want another medication and almost 4{\%} had care-giving responsibilities which prevented involvement. Mass mailings were the most successful approach for recruitment at all four sites and the method through which the vast majority of interviewees had learned about the study. Information on the experience of the GEM Study recruitment may be helpful to other clinical trials attempting to randomize older adults into prevention trials.",
keywords = "Aging, Alzheimer's disease, Clinical trial, Dementia, Elderly, Ginkgo biloba, Recruitment",
author = "Fitzpatrick, {Annette L.} and Fried, {Linda P} and Jeff Williamson and Patricia Crowley and Delilah Posey and Linly Kwong and Janet Bonk and Roberta Moyer and Joyce Chabot and Lara Kidoguchi and Furberg, {Curt D.} and DeKosky, {Steven T.}",
year = "2006",
month = "12",
doi = "10.1016/j.cct.2006.06.007",
language = "English (US)",
volume = "27",
pages = "541--553",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
number = "6",

}

TY - JOUR

T1 - Recruitment of the elderly into a pharmacologic prevention trial

T2 - The Ginkgo Evaluation of Memory Study experience

AU - Fitzpatrick, Annette L.

AU - Fried, Linda P

AU - Williamson, Jeff

AU - Crowley, Patricia

AU - Posey, Delilah

AU - Kwong, Linly

AU - Bonk, Janet

AU - Moyer, Roberta

AU - Chabot, Joyce

AU - Kidoguchi, Lara

AU - Furberg, Curt D.

AU - DeKosky, Steven T.

PY - 2006/12

Y1 - 2006/12

N2 - The difficulty involved in recruiting healthy older adults into clinical trials, especially those involving pharmacologic agents, is an important issue in research. The Ginkgo Evaluation of Memory (GEM) Study, a double-blind, placebo-controlled randomized clinical trial evaluating Ginkgo biloba to prevent dementia, successfully recruited 3072 participants age 75 years and older at four U.S. sites from September 2000 through June 2002. Using targeted mailing lists, an estimated 243,400 study brochures were mailed out to potential participants. Subsequent attempts were made to reach 14,603 households by telephone, from which 12,186 (83.4%) successful contacts were made. Overall, telephone or in-person evaluations identified 2149 (17.6%) ineligible persons for cognitive (20.6%), medical (49.4%), or other (30.0%) reasons. A total of 6944 (57.0%) refused participation resulting in 3072 enrolled into the study, a recruitment rate of 25.2% based on telephone contacts made or 1.3% of all mailed brochures. Recruitment rates were stable over the 21-month enrollment period but were higher for the two urban centers than the two rural ones. Recruitment was dependent most on mailing lists available, density of older adults in the catchment areas, and Institutional Review Board restrictions. Men and persons under age 85 were more likely to enroll. Primary reason for refusals involved lack of interest (48.4%) or self-perceived poor health (16.2%). Over 9% were unwilling to give up current Ginkgo supplementation or would not accept assignment to placebo. An additional 7% did not want another medication and almost 4% had care-giving responsibilities which prevented involvement. Mass mailings were the most successful approach for recruitment at all four sites and the method through which the vast majority of interviewees had learned about the study. Information on the experience of the GEM Study recruitment may be helpful to other clinical trials attempting to randomize older adults into prevention trials.

AB - The difficulty involved in recruiting healthy older adults into clinical trials, especially those involving pharmacologic agents, is an important issue in research. The Ginkgo Evaluation of Memory (GEM) Study, a double-blind, placebo-controlled randomized clinical trial evaluating Ginkgo biloba to prevent dementia, successfully recruited 3072 participants age 75 years and older at four U.S. sites from September 2000 through June 2002. Using targeted mailing lists, an estimated 243,400 study brochures were mailed out to potential participants. Subsequent attempts were made to reach 14,603 households by telephone, from which 12,186 (83.4%) successful contacts were made. Overall, telephone or in-person evaluations identified 2149 (17.6%) ineligible persons for cognitive (20.6%), medical (49.4%), or other (30.0%) reasons. A total of 6944 (57.0%) refused participation resulting in 3072 enrolled into the study, a recruitment rate of 25.2% based on telephone contacts made or 1.3% of all mailed brochures. Recruitment rates were stable over the 21-month enrollment period but were higher for the two urban centers than the two rural ones. Recruitment was dependent most on mailing lists available, density of older adults in the catchment areas, and Institutional Review Board restrictions. Men and persons under age 85 were more likely to enroll. Primary reason for refusals involved lack of interest (48.4%) or self-perceived poor health (16.2%). Over 9% were unwilling to give up current Ginkgo supplementation or would not accept assignment to placebo. An additional 7% did not want another medication and almost 4% had care-giving responsibilities which prevented involvement. Mass mailings were the most successful approach for recruitment at all four sites and the method through which the vast majority of interviewees had learned about the study. Information on the experience of the GEM Study recruitment may be helpful to other clinical trials attempting to randomize older adults into prevention trials.

KW - Aging

KW - Alzheimer's disease

KW - Clinical trial

KW - Dementia

KW - Elderly

KW - Ginkgo biloba

KW - Recruitment

UR - http://www.scopus.com/inward/record.url?scp=33750302960&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33750302960&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2006.06.007

DO - 10.1016/j.cct.2006.06.007

M3 - Article

VL - 27

SP - 541

EP - 553

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

IS - 6

ER -