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*181. Patient Recruitment Challenges in a Behavioral Intervention Clinical Trial of Chronic Heart Failure Patients in the VA

BH Chang, CHQOER, Bedford VAMC; T Lotchin, CHQOER, Bedford VAMC; E Kim, CHQOER, Bedford VAMC; S Zhang, CHQOER, Bedford VAMC; J LoCastro, VA Boston Health Care System; M Slawsky, VA Boston Health Care System; J Rothendler, CHQOER, Bedford VAMC

Objectives: Clinical trials that evaluate the efficacy of behavioral interventions with patients who have chronic diseases face various challenges. Trials that require frequent travel to a VA medical center are even more challenging. We demonstrate the patient recruitment challenge we are facing in a clinical trial "The relaxation response intervention for chronic heart failure (CHF)" which is being currently conducted at the VA Boston Health Care System (BHCS).

Methods: The relaxation response intervention for CHF is a single blinded, three armed, randomized controlled trial. The objective of the trial is to evaluate the efficacy and cost of a relaxation response intervention. The intervention consists of 15 weekly 90-minute relaxation response group sessions held at the Jamaica Plain campus of the VA BHCS. Two control groups are used: a 15-week cardiac education group and usual care. Patient inclusion criteria are 1) moderate levels of exercise intolerance (New York Heart Association Class II & III) 2) left ventricular ejection fraction <=40%, and 3) undergoing the established standard protocol of pharmacological treatments. The exclusion criteria are: 1) participation in a cardiac rehabilitation program and 2) cognitive impairment. Patients were first recruited at the Heart Failure Clinic at the VA BHCS. As a strategy to increase the patient enrollment, the recruitment was then expanded to the cardiac clinics at the VA BHCS in Jamaica Plain (JP) and West Roxbury campuses and the primary care clinics in JP. We summarized the recruitment statistics for the initial 4 month recruitment period.

Results: Of the 170 patients who had an appointment in the Heart Failure Clinic on the recruitment days between April 25, 2000 and September 15,2000, 91 patients (54%) were not eligible, and an additional 16 patients did not show up for the appointment. Sixty-three patients remained for screening. Among those screened, 41% (n=26) declined, 33% (n=21) consented to the study, 5% (N=3) were determined to be ineligible after screening, and 21% (N=13) did not complete the screening due to various reasons. Thirteen out of 21 who consented have completed the baseline assessment to date. The consent rate in the other clinics is even lower. The primary reasons for declining to participate in the study were too great a traveling distance and transportation access problems.

Conclusions: Recruitment statistics in this initial 4 month period indicate the difficulty in enrolling patients into a behavioral intervention clinical trial. Aside from study exclusion criteria, the main barrier to participation appeared to be the travel distance required for participation and/or transportation issues.

Impact: Our experience in patient recruitment for this clinical trial suggests that for studies requiring an elderly population with a chronic medical condition to make frequent visits to a VA medical center, transportation issues can be a critical determinant for participation. Researchers need to carefully evaluate available transportation options in their geographic areas in the planning of such projects. Other options that require minimum or no traveling such as home study video tapes or Internet based two-way video conferencing might be considered for future studies.