期刊
TRIALS
卷 15, 期 -, 页码 -出版社
BMC
DOI: 10.1186/1745-6215-15-321
关键词
Type 1 diabetes mellitus; Adolescents; Outpatient clinic; Hospital; Clinical trials; Randomization; Empowerment
资金
- Research Foundation at Hillerod Hospital
- Novo Nordisk Foundation
- Lundbeck Foundation
- Sahva Foundation
- Tryg Foundation
- Foundation of Senior Lieutenant Harald Jensen and Wife
- Pediatric Department at Hillerod Hospital
- Research Foundation of the Capital Region of Denmark
- Foundation of Mrs. Lily Benthine Lund
- Axel Muusfeldt Foundation
- Foundation of Master Cabinetmaker Sophus Jacobsen and his wife Astrid Jacobsen
- Ville Heise Foundation
- Beckett Foundation
- Health Insurance Foundation
Background: Providing care for adolescents with type 1 diabetes is complex, demanding, and often unsuccessful. Guided self-determination (GSD) is a life skills approach that has been proven effective in caring for adults with type 1 diabetes. To improve care, GSD was revised for adolescents, their parents, and interdisciplinary healthcare providers (HCP) to create GSD-Youth (GSD-Y). We evaluated the impact of GSD-Y after it was integrated into pediatric outpatient visits versus treatment-as-usual, focusing on glycemic control and the development of life skills in adolescents with type 1 diabetes. Methods: Seventy one adolescents (mean age: 15 years, mean duration of diabetes: 5.7 years, mean HbA1c: 77 mmol/mol (9.1%), upon entering the study) from two pediatric departments were randomized into a GSD-Y group (n = 37, GSD-Y was provided during individual outpatient sessions) versus a treatment-as-usual group (n = 34). The primary outcome was the HbA1c measurement. The secondary outcomes were life skills development (assessed by self-reported psychometric scales), self-monitored blood glucose levels, and hypo- and hyperglycemic episodes. The analysis followed an intention-to-treat basis. Results: Fifty-seven adolescents (80%) completed the trial, and 53 (75%) completed a six-month post-treatment follow-up. No significant effect of GSD-Y on the HbA1c could be detected in a mixed-model analysis after adjusting for the baseline HbA1c levels and the identity of the HCP (P = 0.85). GSD-Y significantly reduced the amotivation for diabetes self-management after adjusting for the baseline value (P = 0.001). Compared with the control group, the trial completion was prolonged in the GSD-Y group (P < 0.001), requiring more visits (P = 0.05) with a higher rate of non-attendance (P = 0.01). GSD-Y parents participated in fewer of the adolescents' visits (P = 0.05) compared with control parents. Conclusions: Compared with treatment-as-usual, GSD-Y did not improve HbA1c levels, but it did decrease adolescents' amotivation for diabetes self-management.
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