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P20 Participant perception of the role and benefits of study coordinators: Results of a pilot study
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Abstracts P20 PARTICIPANT PERCEPTION OF THE ROLE AND BENEFITS OF STUDY COORDINATORS: RESULTS OF A PILOT STUDY Jayne Mitchell, Rebecca Letterer, Kay Zolezzi, Nancy P&sky, Audrey Rossow, Deb Towery, Kathy Belew, Gail BoIIing, Charlotte Lavoie, Marie Kleman, Jolene Durham, Lara Simpson and Liia Brown for the CARE Study Coordinators Legacy Research Services Portland, Oregon
A mid-trial blinded questionnaire was administered to participants via mail at 3 sites in the Cholesterol and Recurrent Events (CARE) study, a 5-year secondary prevention trial for post MI patients. The purpose of the questionnaire was to assess determinants of successful participation and adherencein a long-term trial. Sixty percent (N=169) of the eligible patients responded to the survey. Respondents rated their relationship with the coordinator as either excellent (93%), or good (6%). The overwhelming majority (89%) believed their nurse coordinator bad positively influenced their participation. Attributes which respondents rated as either most beneficial or beneficial included: “listening to my concerns” (89%), “informs me about study” (86%), “provides answers to my questions” (85%), “teaches me about health” (78%), “refers me to my provider” (71%), and “coordinates my care” (68%). Participants in this long-term trial perceived the role of nurse coordinators as supportive and informative and these benefits positively influenced their study participation. Thus, nurse coordinators can play a pivotal role iu patient adherence and the successful conduct of long term clinical trials. P21 STEPS IN THE DEVELOPMENT OF A DISEASE-SPECIFIC QUALITY OF LIFE MEASURE Nancy Fink, Albert Wu, Kathleen Cagney, Klemens Meyer, Robert Herbert, MoIIie Jenckes, John Sadler and Neil Powe for the CHOICE Study Johns Hoptis University Baltimore, Maryland OBJECTIVE: To develop a measure of health-related quality of life for a multicenter study of End-Stage Renal Disease (ESRD) patients that would complement the SF-36 and be sensitive to differences in dialysis modality (hemodialysis, and peritoneal dialysis) and dose. METHODS: Domain and item generation was based on: 1) a structured literature review (65 articles, 83 instruments); 2) five focus groups of patients, nepbrologists, or other dialysis providers (content analysis of transcripts); 3) a survey of 110 dialysis providers eliciting concerns and relevant features of modalities; 4) an opened ended survey of 25 patients on the effects of dialysis on functioning and quality of life. Two more steps prioritized selection of domains and items; 5) 152 patients rated 100 quality of life items for frequency/bother; 6) nepbrologists rated items likely to be affected by dose. RESULTS: The frst 4 steps yielded 21 candidate domains composed of 100 total items: 8 generic domains in SF-36; 7 additional generic domains (cognitive functioning, sexual functioning, sleep, work, recreation, finances and quality of life); and 6 ESRD specific domains (access, diet, freedom, time, body image, and symptoms). Logistic regression analyses assessing the independent association of modality on the frequency/bother
Abstracts P20 PARTICIPANT PERCEPTION OF THE ROLE AND BENEFITS OF STUDY COORDINATORS: RESULTS OF A PILOT STUDY Jayne Mitchell, Rebecca Letterer, Kay Zolezzi, Nancy P&sky, Audrey Rossow, Deb Towery, Kathy Belew, Gail BoIIing, Charlotte Lavoie, Marie Kleman, Jolene Durham, Lara Simpson and Liia Brown for the CARE Study Coordinators Legacy Research Services Portland, Oregon
A mid-trial blinded questionnaire was administered to participants via mail at 3 sites in the Cholesterol and Recurrent Events (CARE) study, a 5-year secondary prevention trial for post MI patients. The purpose of the questionnaire was to assess determinants of successful participation and adherencein a long-term trial. Sixty percent (N=169) of the eligible patients responded to the survey. Respondents rated their relationship with the coordinator as either excellent (93%), or good (6%). The overwhelming majority (89%) believed their nurse coordinator bad positively influenced their participation. Attributes which respondents rated as either most beneficial or beneficial included: “listening to my concerns” (89%), “informs me about study” (86%), “provides answers to my questions” (85%), “teaches me about health” (78%), “refers me to my provider” (71%), and “coordinates my care” (68%). Participants in this long-term trial perceived the role of nurse coordinators as supportive and informative and these benefits positively influenced their study participation. Thus, nurse coordinators can play a pivotal role iu patient adherence and the successful conduct of long term clinical trials. P21 STEPS IN THE DEVELOPMENT OF A DISEASE-SPECIFIC QUALITY OF LIFE MEASURE Nancy Fink, Albert Wu, Kathleen Cagney, Klemens Meyer, Robert Herbert, MoIIie Jenckes, John Sadler and Neil Powe for the CHOICE Study Johns Hoptis University Baltimore, Maryland OBJECTIVE: To develop a measure of health-related quality of life for a multicenter study of End-Stage Renal Disease (ESRD) patients that would complement the SF-36 and be sensitive to differences in dialysis modality (hemodialysis, and peritoneal dialysis) and dose. METHODS: Domain and item generation was based on: 1) a structured literature review (65 articles, 83 instruments); 2) five focus groups of patients, nepbrologists, or other dialysis providers (content analysis of transcripts); 3) a survey of 110 dialysis providers eliciting concerns and relevant features of modalities; 4) an opened ended survey of 25 patients on the effects of dialysis on functioning and quality of life. Two more steps prioritized selection of domains and items; 5) 152 patients rated 100 quality of life items for frequency/bother; 6) nepbrologists rated items likely to be affected by dose. RESULTS: The frst 4 steps yielded 21 candidate domains composed of 100 total items: 8 generic domains in SF-36; 7 additional generic domains (cognitive functioning, sexual functioning, sleep, work, recreation, finances and quality of life); and 6 ESRD specific domains (access, diet, freedom, time, body image, and symptoms). Logistic regression analyses assessing the independent association of modality on the frequency/bother