Effect of guided self-determination youth intervention integrated into outpatient visits versus treatment as usual on glycemic control and life skills: a randomized clinical trial in adolescents with type 1 diabetes
1 Department of Pediatrics, Nordsjællands Hospital Hillerød, University of Copenhagen, Dyrehavevej 29, 3400 Hillerød, Denmark
2 Patient Education Research, Steno Health Promotion Center, Steno Diabetes Center, Niels Steensens Vej 8, 2820 Gentofte, Denmark
3 Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital Hillerød, University of Copenhagen, Dyrehavevej 29, 3400 Hillerød, Denmark
4 Research Unit of Nursing and Health Science, Copenhagen University Hospital, Glostrup, Ndr. Ringvej 57, 2600 Glostrup, Denmark
5 Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, Denmark
6 Copenhagen Trial Unit, Center for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark
7 Steno Diabetes Center, Niels Steensensvej 2, 2820 Gentofte, Denmark
8 Juliane Marie Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark
9 Nasjonal kompetansetjeneste for læring og mestring innen helse (NKLMH) Oslo University Hospital, Kierkeveien 166, 0424 Olso, Norway
Trials 2014, 15:321 doi:10.1186/1745-6215-15-321Published: 12 August 2014
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.
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.
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.
Compared with treatment-as-usual, GSD-Y did not improve HbA1c levels, but it did decrease adolescents’ amotivation for diabetes self-management.
ISRCTN 54243636, registered on 10 January 2010. Life skills for adolescents with type 1 diabetes and their parents.