[A multi-center, randomized control trial on clinical research education to diabetes patients].

OBJECTIVE

To assess the effect of implementing education about clinical research in changing the awareness and attitudes of diabetic patients.

METHODS

A randomized control trial was implemented in 258 patients with diabetes from 6 hospitals. The participants were assigned to the intervention group (129 cases, who received education about the clinical research) and the control group (129 cases, who received no intervention). The outcome indicators were the variables on knowledge, attitude for the clinical research between before and after intervention in the same group and between the two groups.

RESULTS

There was no withdrawal or lost in the two groups. Comparing the contents between inter-groups and intra-group for 19 assignment questions, it showed statistical significance (P<0.05). After the patients received education, their knowledge about and attitude towards clinical research, informed consent, placebo, follow-up, random allocation, and ethics, etc. were markedly improved. Their attitudes for the participants to join in scientific research, opinion, confidence were obviously changed, and it also showed that the method was feasible. The patients' education level was positively correlated with the clinical research educated outputs.

CONCLUSION

This study proved the necessity for patients participating in future clinical trials to receive education, as well as its feasibility and effectiveness.