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dc.contributor.authorChang, Bei-Hungen_US
dc.contributor.authorHendricks, Ann Men_US
dc.contributor.authorSlawsky, Mara Ten_US
dc.contributor.authorLocastro, Joseph Sen_US
dc.date.accessioned2011-12-29T23:09:23Z
dc.date.available2011-12-29T23:09:23Z
dc.date.copyright2004
dc.date.issued2004-4-17
dc.identifier.citationChang, Bei-Hung, Ann M Hendricks, Mara T Slawsky, Joseph S Locastro. "Patient recruitment to a randomized clinical trial of behavioral therapy for chronic heart failure" BMC Medical Research Methodology 4:8. (2004)
dc.identifier.issn1471-2288
dc.identifier.urihttps://hdl.handle.net/2144/2638
dc.description.abstractBACKGROUND: Patient recruitment is one of the most difficult aspects of clinical trials, especially for research involving elderly subjects. In this paper, we describe our experience with patient recruitment for the behavioral intervention randomized trial, "The relaxation response intervention for chronic heart failure (RRCHF)." Particularly, we identify factors that, according to patient reports, motivated study participation. METHODS: The RRCHF was a three-armed, randomized controlled trial designed to evaluate the efficacy and cost of a 15-week relaxation response intervention on veterans with chronic heart failure. Patients from the Veterans Affairs (VA) Boston Healthcare System in the United States were recruited in the clinic and by telephone. Patients' reasons for rejecting the study participation were recorded during the screening. A qualitative sub-study in the trial consisted of telephone interviews of participating patients about their experiences in the study. The qualitative study included the first 57 patients who completed the intervention and/or the first follow-up outcome measures. Factors that distinguished patients who consented from those who refused study participation were identified using a t-test or a chi-square test. The reason for study participation was abstracted from the qualitative interview. RESULTS: We successfully consented 134 patients, slightly more than our target number, in 27 months. Ninety-five of the consented patients enrolled in the study. The enrollment rate among the patients approached was 18% through clinic and 6% through telephone recruitment. The most commonly cited reason for declining study participation given by patients recruited in the clinic was 'Lives Too Far Away'; for patients recruited by telephone it was 'Not Interested in the Study'. One factor that significantly distinguished patients who consented from patients who declined was the distance between their residence and the study site (t-test: p < .001). The most frequently reported reason for study participation was some benefit to the patient him/herself. Other reasons included helping others, being grateful to the VA, positive comments by trusted professionals, certain characteristics of the recruiter, and monetary compensation. CONCLUSIONS: The enrollment rate was low primarily because of travel considerations, but we were able to identify and highlight valuable information for planning recruitment for future similar studies.en_US
dc.description.sponsorshipDepartment of Veterans Affairs; Health Services Research and Development Grant (IIR 99-241)en_US
dc.language.isoen
dc.publisherBioMed Centralen_US
dc.rightsCopyright 2004 Chang et al; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.en_US
dc.titlePatient Recruitment to a Randomized Clinical Trial of Behavioral Therapy for Chronic Heart Failureen_US
dc.typeArticleen_US
dc.identifier.doi10.1186/1471-2288-4-8
dc.identifier.pmid15090073
dc.identifier.pmcid404462


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