Evaluating Recruitment Strategies for a Randomized Clinical Trial with Heart Failure Patients

Conley, Samantha; O’Connell, Meghan; Linsky, Sarah; Moemeka, Lesa; Darden, James W.; Gaiser, Edward; Jacoby, Daniel; Yaggi, H. Klar; Redeker, Nancy S.

doi:10.1177/0193945920970229

Cited by 13 publications

(8 citation statements)

References 12 publications

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“…In addition, by assessing the crude randomization output, which ultimately completes the study sample, both press media and word of mouth were important sample sources for CC and PC, respectively. Thus, consistent with previous studies [13,18], it was essential to use varied recruitment strategies to reach the estimated number of individuals in our trial. We highlight that the word of mouth method resulted in a high yield rate as well as crude recruitment output at the PC.…”

Section: Discussionsupporting

confidence: 60%

“…Many recruitment strategies exist to target potential research participants, and although some previous studies tried to explore these in different fields [10][11][12][13], it is unclear which strategies were the most useful. The effectiveness of recruitment strategies depends on population factors, such as physical, demographic and clinical characteristics, as well as the trial setting and type of study intervention [14].…”

Section: Introductionmentioning

confidence: 99%

“…The effectiveness of recruitment strategies depends on population factors, such as physical, demographic and clinical characteristics, as well as the trial setting and type of study intervention [14]. Hence, analyses of the yield rate of recruitment methods may be highly informative for future studies [10,11,13], especially those methods conducted with a limited research budget.…”

Section: Introductionmentioning

confidence: 99%

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Recruitment methods and yield rates in a clinical trial of physical exercise for older adults with hypertension—HAEL Study: a study within a trial

Botton

Santos

Moraes

et al. 2022

BMC Med Res Methodol

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Background Although the prevalence of hypertension is high in older adults, clinical trial recruitment is a challenge. Our main aim was to describe the HAEL Study recruitment methods and yield rates. The secondary objectives were to explore the reasons for exclusion and to describe the characteristics of the enrolled participants. Methods This is a descriptive study within a trial. The HAEL Study was a Brazilian randomized two-center, parallel trial with an estimated sample of 184 participants. The recruitment strategy was based on four methods: electronic health records, word of mouth, print and electronic flyer, and press media. The yield rate was the ratio of the number of participants who underwent randomization to the total number of volunteers screened, calculated for overall, per recruitment method, by study center and by age group and sex. Additionally, we described the reasons for exclusion in the screening phase, as well as the demographic characteristics of those enrolled. The data are presented in absolute/relative frequencies and mean ± standard deviation. Results A total of 717 individuals were screened, and 168 were randomized over 32 months. The yield rate was higher for word of mouth (30.1%) in the overall sample. However, press media contributed the most (39.9%) to the absolute number of participants randomized in the trial. The coordinating center and participating center differed in methods with the highest yield ratios and absolute numbers of randomized participants. The main reason for exclusion in the screening phase was due to the physically active status in those intending to participate in the study (61.5%). Out of 220 participants included, 52 were excluded mainly because they did not meet the eligibility criteria (26.9%). Most of the screened volunteers were women (60.2%) age 60–69 years (59.5%), and most of the randomized participants were Caucasian/white (78.0%). Conclusions Multiple recruitment methods constituted effective strategies. We observed that approximately one of every four individuals screened was allocated to an intervention group. Even so, there were limitations in obtaining a representative sample of older Brazilian adults with hypertension. Data show an underrepresentation of race and age groups. Trial registration This SWAT was not registered.

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Section: Discussionsupporting

confidence: 60%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Recruitment methods and yield rates in a clinical trial of physical exercise for older adults with hypertension—HAEL Study: a study within a trial

Botton

Santos

Moraes

et al. 2022

BMC Med Res Methodol

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“…We obtained baseline data from 195 participants. Their demographic and clinical characteristics appear in Table 1 and were published previously (Conley et al, 2020). The sample was predominantly male (56.9%), with 17.9% of participants self-identified as Black race, 74.9% self-identified as White, and 7.2% were of other racial backgrounds.…”

Section: Resultsmentioning

confidence: 99%

Sleep Characteristics, Mood, Somatic Symptoms, and Self-Care Among People With Heart Failure and Insomnia

et al. 2022

Self Cite

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BackgroundAlmost 50% of people with heart failure (HF) experience chronic insomnia and must perform self-care to manage their day-to-day healthcare needs. Understanding multifactorial influences on self-care, including demographic, clinical, and sleep characteristics, and mood and somatic symptoms will help identify people at highest risk for poor self-care. However, past research focused only on the associations of single symptoms and self-care. Multivariate approaches are needed to account for the synergistic associations of self-care with sleep, mood, and somatic symptoms among people with HF.ObjectivesThe aims of the study were to (a) evaluate the levels of self-care maintenance and self-care confidence among people with stable HF and chronic insomnia; (b) identify the clinical and demographic correlates of self-care maintenance and confidence among people with stable HF and chronic insomnia; and (c) identify the associations between sleep characteristics, mood and somatic symptoms, and self-care maintenance and confidence among people with stable HF and chronic insomnia.MethodsWe utilized a cross-sectional design with 195 adult participants who had chronic HF and insomnia. We assessed for symptoms of anxiety; depression; dyspnea; fatigue; stress; insomnia severity; and sleep disturbance, impairment, and quality. Self-care was measured using the Self-Care for Heart Failure Index v6.2. We used generalized linear models to test the associations between the demographic and clinical factors and self-care maintenance and confidence; exploratory and confirmatory factor analysis to identify the factor structure underlying the symptoms; and structural equation modeling to test the combined associations of the demographic and clinical factors and latent factors with self-care maintenance and confidence.ResultsSelf-care maintenance, confidence, and management were inadequate in most participants. We identified three latent factors among the nine symptoms: “sleep characteristics,” “mood,” and “somatic symptoms.” In the structural equation model, “sleep characteristics,” White race, and having a left ventricular ejection fraction of <45 were associated with self-care maintenance. Age was negatively associated with self-care confidence.DiscussionPoor sleep characteristics negatively influence the ability of people with HF and insomnia to perform self-care behaviors. Knowledge of the associations among age, left ventricular ejection fraction, and race with self-care will help clinicians and future researchers identify those at risk for poor self-care.

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“…This method, using the EHR cohort identification and patient portal recruitment messaging (PPRM), has been effective at identifying and enrolling individuals in clinical research studies and is an efficient recruitment method for some study teams. [12][13][14] Importantly, more than 90% of participants in a previous study agreed that PPRM for recruitment was an appropriate use of the patient portal. 10 Despite the rapid expansion of PPRM in the last five to seven years, the literature on acceptability and best practices for its use has not substantially grown, leaving limited guidance for institutions that offer or plan to offer PPRM as a recruitment method.…”

Section: Introductionmentioning

confidence: 99%

Describing current use, barriers, and facilitators of patient portal messaging for research recruitment: Perspectives from study teams and patients at one institution

Miller¹,

Lindo²,

Fish³

et al. 2023

J. Clin. Trans. Sci.

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Evaluating Recruitment Strategies for a Randomized Clinical Trial with Heart Failure Patients

Cited by 13 publications

References 12 publications

Recruitment methods and yield rates in a clinical trial of physical exercise for older adults with hypertension—HAEL Study: a study within a trial

Recruitment methods and yield rates in a clinical trial of physical exercise for older adults with hypertension—HAEL Study: a study within a trial

Sleep Characteristics, Mood, Somatic Symptoms, and Self-Care Among People With Heart Failure and Insomnia

Describing current use, barriers, and facilitators of patient portal messaging for research recruitment: Perspectives from study teams and patients at one institution

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