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Recruitment Methods, Inclusion, and Successful Participation in a Longitudinal Clinical Trial Using Ecological Momentary Assessment

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Title: Recruitment Methods, Inclusion, and Successful Participation in a Longitudinal Clinical Trial Using Ecological Momentary Assessment
Language: English
Authors: Norman Porticella (ORCID 0000-0002-1763-2472), Julie S. Cannon, Chung Li Wu, Stuart G. Ferguson, James F. Thrasher, Emily E. Hackworth, Jeff Niederdeppe
Source: Health Education & Behavior. 2024 51(2):280-290.
Availability: SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: https://sagepub.com
Peer Reviewed: Y
Page Count: 11
Publication Date: 2024
Sponsoring Agency: National Cancer Institute (NCI) (DHHS/NIH)
Contract Number: R01CA215466
Document Type: Journal Articles
Reports - Research
Descriptors: Recruitment, Disproportionate Representation, Medical Research, Compliance (Psychology), Longitudinal Studies, Measurement Techniques, Randomized Controlled Trials, Smoking, Merchandise Information, Health Promotion, Intervention
DOI: 10.1177/10901981231210520
ISSN: 1090-1981
1552-6127
Abstract: Underrepresentation of historically marginalized populations in clinical trials continues to threaten the validity of health intervention research. Evidence supports the merits of intercept and other proactive forms of recruitment for achieving more equitable representation. However, researchers also report lower retention and adherence to protocols among these populations, particularly in longitudinal studies. Few studies have compared recruitment methods for longitudinal randomized trials testing health interventions, with even fewer having done so for trials involving ecological momentary assessment (EMA). As intervention research integrates EMA and other data collection approaches requiring substantial participant effort, it is critical to better understand the effectiveness and implications of strategies to improve the representativeness of health research. This secondary data analysis compared outcomes of proactive and reactive recruitment strategies (mobile lab intercepts and internet/flyer advertising, respectively) in study inclusion, task completion, and retention within a 14-day randomized controlled trial that used EMA to evaluate cigarette package health messages. Proactive recruitment resulted in higher proportions of participants with low income and education, limited health literacy, and of diverse racial/ethnic makeup. However, this recruitment method also resulted in lower task completion, especially in the second week of the trial period, and lower retention, although group differences were not explained by participant sociodemographic characteristics targeted by inclusion efforts. We conclude that proactive recruitment via intercepts is an effective strategy for health intervention research that aims to include stakeholders from historically marginalized groups but that researchers and funders must recognize these methods require additional resources, considerations, and capacity to address non-trivial challenges to successful participation.
Abstractor: As Provided
Entry Date: 2024
Accession Number: EJ1419111
Database: ERIC
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  Data: Recruitment Methods, Inclusion, and Successful Participation in a Longitudinal Clinical Trial Using Ecological Momentary Assessment
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  Data: <searchLink fieldCode="AR" term="%22Norman+Porticella%22">Norman Porticella</searchLink> (ORCID <externalLink term="https://orcid.org/0000-0002-1763-2472">0000-0002-1763-2472</externalLink>)<br /><searchLink fieldCode="AR" term="%22Julie+S%2E+Cannon%22">Julie S. Cannon</searchLink><br /><searchLink fieldCode="AR" term="%22Chung+Li+Wu%22">Chung Li Wu</searchLink><br /><searchLink fieldCode="AR" term="%22Stuart+G%2E+Ferguson%22">Stuart G. Ferguson</searchLink><br /><searchLink fieldCode="AR" term="%22James+F%2E+Thrasher%22">James F. Thrasher</searchLink><br /><searchLink fieldCode="AR" term="%22Emily+E%2E+Hackworth%22">Emily E. Hackworth</searchLink><br /><searchLink fieldCode="AR" term="%22Jeff+Niederdeppe%22">Jeff Niederdeppe</searchLink>
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  Data: <searchLink fieldCode="SO" term="%22Health+Education+%26+Behavior%22"><i>Health Education & Behavior</i></searchLink>. 2024 51(2):280-290.
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  Data: SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: https://sagepub.com
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  Data: <searchLink fieldCode="DE" term="%22Recruitment%22">Recruitment</searchLink><br /><searchLink fieldCode="DE" term="%22Disproportionate+Representation%22">Disproportionate Representation</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+Research%22">Medical Research</searchLink><br /><searchLink fieldCode="DE" term="%22Compliance+%28Psychology%29%22">Compliance (Psychology)</searchLink><br /><searchLink fieldCode="DE" term="%22Longitudinal+Studies%22">Longitudinal Studies</searchLink><br /><searchLink fieldCode="DE" term="%22Measurement+Techniques%22">Measurement Techniques</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+Controlled+Trials%22">Randomized Controlled Trials</searchLink><br /><searchLink fieldCode="DE" term="%22Smoking%22">Smoking</searchLink><br /><searchLink fieldCode="DE" term="%22Merchandise+Information%22">Merchandise Information</searchLink><br /><searchLink fieldCode="DE" term="%22Health+Promotion%22">Health Promotion</searchLink><br /><searchLink fieldCode="DE" term="%22Intervention%22">Intervention</searchLink>
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  Data: 10.1177/10901981231210520
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  Data: 1090-1981<br />1552-6127
– Name: Abstract
  Label: Abstract
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  Data: Underrepresentation of historically marginalized populations in clinical trials continues to threaten the validity of health intervention research. Evidence supports the merits of intercept and other proactive forms of recruitment for achieving more equitable representation. However, researchers also report lower retention and adherence to protocols among these populations, particularly in longitudinal studies. Few studies have compared recruitment methods for longitudinal randomized trials testing health interventions, with even fewer having done so for trials involving ecological momentary assessment (EMA). As intervention research integrates EMA and other data collection approaches requiring substantial participant effort, it is critical to better understand the effectiveness and implications of strategies to improve the representativeness of health research. This secondary data analysis compared outcomes of proactive and reactive recruitment strategies (mobile lab intercepts and internet/flyer advertising, respectively) in study inclusion, task completion, and retention within a 14-day randomized controlled trial that used EMA to evaluate cigarette package health messages. Proactive recruitment resulted in higher proportions of participants with low income and education, limited health literacy, and of diverse racial/ethnic makeup. However, this recruitment method also resulted in lower task completion, especially in the second week of the trial period, and lower retention, although group differences were not explained by participant sociodemographic characteristics targeted by inclusion efforts. We conclude that proactive recruitment via intercepts is an effective strategy for health intervention research that aims to include stakeholders from historically marginalized groups but that researchers and funders must recognize these methods require additional resources, considerations, and capacity to address non-trivial challenges to successful participation.
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      – SubjectFull: Recruitment
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