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| Effectiveness of lifestyle counseling by certified expert nurse of Japan for non-insulin-treated diabetic outpatients: a 1-year randomized controlled trial |
| Shibayama T, Kobayashi K, Takano A, Kadowaki T, Kazuma K |
| Diabetes Research and Clinical Practice 2007 May;76(2):265-268 |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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We examine whether one-to-one lifestyle counseling for non-insulin-treated diabetic outpatients by a certified expert nurse (CEN) can improve patients' health outcomes. Participants were randomly assigned to a 1-year lifestyle intervention (n = 67) or to a usual care group (n = 67). Main outcome measures were changes from baseline in: HbA1C and score of health related quality of life scales (SF-36 and Problem Areas in Diabetes Scale). Cognitive/behavioral modification for 1 year and satisfaction in CEN counseling was also measured by self-produced items. We found no significant differences in HbA1C, BMI, blood pressure, serum lipids, or health related quality of life over 1 year between the two groups. Patients in the intervention group, however, showed modest but more favorable modification of cognition (p = 0.004) and behavior (p < 0.001) than subjects in usual care group. The low attrition rate (9%), more frequent hospital visit (12 +/- 2 times versus 11 +/- 3 times; p = 0.03) and high degree of satisfaction (95%) in the intervention group indicate feasibility of the monthly CEN counseling in the outpatient settings of Japanese hospitals. Future research should confirm the long-term effectiveness of the CEN counseling on clinical outcomes and the cost effectiveness of a possibly time-consuming intervention.
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