OBJECTIVE: To assess participant and parent experiences in the parenteral insulin arm of the Diabetes Prevention Trial for Type 1 Diabetes (DPT-1). RESEARCH DESIGN AND METHODS: Before trial results were publicized, surveys were completed by 82 intervention participants (the intervention group) (who received annual 4-day insulin infusions and daily insulin injections), 81 closely monitored control subjects (the closely monitored group), and 135 parents of children in the trial. RESULTS: Survey results suggest that participant perspective (adult, child, parent, and sex), study procedures, and group assignment have important implications when planning clinical trials. Parents rated the trial more favorably but worried about hypoglycemia and diabetes onset. Children had the least favorable reaction to the study. Parents preferred assignment to the intervention group; child/adult participants preferred assignment to the closely monitored group. The intervention group rated the annual 4-day insulin infusions more negatively than all other study procedures. Intervention group participants/parents reported poorer insulin injection adherence over the course of the study. Intervention group participants, parents, and female subjects expressed an interest in additional psychosocial support during the trial. Random assignment was viewed negatively by both study groups. Close observation for diabetes onset was viewed as the most favorable aspect of the study. Behaviors outside of the study protocol to prevent or delay diabetes onset were common and should be monitored in future prevention studies. CONCLUSIONS: Overall, most participants were positive about the trial, and many expressed optimism about the intervention's potential for success. These results have implications for study design, recruitment, and retention procedures in future prevention trials.
RCT Entities:
OBJECTIVE: To assess participant and parent experiences in the parenteral insulin arm of the Diabetes Prevention Trial for Type 1 Diabetes (DPT-1). RESEARCH DESIGN AND METHODS: Before trial results were publicized, surveys were completed by 82 intervention participants (the intervention group) (who received annual 4-day insulin infusions and daily insulin injections), 81 closely monitored control subjects (the closely monitored group), and 135 parents of children in the trial. RESULTS: Survey results suggest that participant perspective (adult, child, parent, and sex), study procedures, and group assignment have important implications when planning clinical trials. Parents rated the trial more favorably but worried about hypoglycemia and diabetes onset. Children had the least favorable reaction to the study. Parents preferred assignment to the intervention group; child/adult participants preferred assignment to the closely monitored group. The intervention group rated the annual 4-day insulin infusions more negatively than all other study procedures. Intervention group participants/parents reported poorer insulin injection adherence over the course of the study. Intervention group participants, parents, and female subjects expressed an interest in additional psychosocial support during the trial. Random assignment was viewed negatively by both study groups. Close observation for diabetes onset was viewed as the most favorable aspect of the study. Behaviors outside of the study protocol to prevent or delay diabetes onset were common and should be monitored in future prevention studies. CONCLUSIONS: Overall, most participants were positive about the trial, and many expressed optimism about the intervention's potential for success. These results have implications for study design, recruitment, and retention procedures in future prevention trials.
Authors: Eszter Goldstein; Robert Hermann; Timo J Renfors; Kirsti M Näntö-Salonen; Tapio Korhonen; Maarit Kärkkäinen; Riitta K Veijola; Mikael Knip; Tuula T Simell; Olli G Simell Journal: Diabetes Care Date: 2009-09-14 Impact factor: 19.112
Authors: Ulrica Swartling; Kristian Lynch; Laura Smith; Suzanne Bennett Johnson Journal: J Empir Res Hum Res Ethics Date: 2016-05-30 Impact factor: 1.978
Authors: Jay M Sosenko; Jerry P Palmer; Lisa Rafkin-Mervis; Jeffrey P Krischer; David Cuthbertson; Della Matheson; Jay S Skyler Journal: Diabetes Care Date: 2008-07-23 Impact factor: 17.152
Authors: Laura B Smith; Kristian F Lynch; Judith Baxter; Barbro Lernmark; Roswith Roth; Tuula Simell; Suzanne Bennett Johnson Journal: Diabetes Care Date: 2013-09-16 Impact factor: 17.152